Injury, Int. J. Care Injured 46 (2015) 1562–1566
Contents lists available at ScienceDirect
Injury journal homepage: www.elsevier.com/locate/injury
General versus regional anaesthesia for hip fractures. A pilot randomised controlled trial of 322 patients Martyn J. Parker a,*, Richard Griffiths b a b
Department of Orthopaedics, Peterborough and Stamford Hospital NHS Foundation Trust, Peterborough City Hospital, United Kingdom Department of Anaesthesia, Peterborough and Stamford Hospital NHS Foundation Trust, Peterborough City Hospital, United Kingdom
A R T I C L E I N F O
A B S T R A C T
Article history: Accepted 1 May 2015
Uncertainty remains regarding the optimum method of anaesthesia for hip fracture surgery. We randomised 322 patients with a hip fracture to receive either general anaesthesia or regional (spinal) anaesthesia. Surviving patients were followed up to 1 year from injury. There was no notable difference in the outcomes of hospital stay, need for blood transfusion or post-operative complications between groups. 30-day mortality was marginally reduced for spinal anaesthesia 7/164(4.3%) versus 5/158(3.2%) (p = 0.57), whilst at 1 year it was less for general anaesthesia 20/163(12.1%) versus 32/158(20.2%) (p = 0.05). Within the confines of the limited patient numbers studied we conclude that there are no marked differences in outcome between the two techniques. ß 2015 Elsevier Ltd. All rights reserved.
Keywords: Hip fracture Anaesthesia Randomised trial
Introduction
Patients and methods
At present about 1.5 million hip fractures occur each year around the world with numbers predicted increase to between 7 and 21 million by 2050 [1]. In the UK the incidence is about 77,000 [2]. The number of hip fractures in England is expected to reach 100,000 by the year 2033 [[3_TD$IF]3]. The majority of these fractures are treated surgically requiring some form of anaesthesia. Despite the frequent nature of the condition controversy still exists regarding the optimum choice of anaesthesia [4–6]. For specific groups of patients one particular type of anaesthesia may be preferred. For example those with chest disease are felt to be better treated with spinal anaesthesia, whilst for those on warfarin general anaesthesia (GA) is more likely to be chosen. There remains a substantial proportion of patients for which either technique may be used. This study aims to revisit this controversy by randomising 322 patients with a hip fracture to either regional or general anaesthesia to see if there is any suggestion of a significant benefit for either technique.
The protocol for this study is that it only included those patients aged over 49 years of age presenting to one hospital with an acute hip fracture. Discussion with study participants was undertaken by the lead trialist ([4_TD$IF]MJP). Patient with dementia were included if their next was willing to allow their relative to participate in the study. Patients with more than one injury were included within the study if spinal anaesthesia was suitable for all necessary surgical procedures. Patients who expressed a preference to a particular method of anaesthesia were excluded at their request. In addition those patients in whom either the attending anaesthetist or surgeon felt either technique was more appropriate were also excluded. Randomisation was undertaken by the opening of sealed opaque numbered envelopes, which were prepared at the start of the study by a person independent to the trial. Each envelope contained details of the type of anaesthesia to be given (general versus spinal anaesthesia). The exact technique and doses of drugs used for the different types of anaesthesia was the choice of the anaesthetist. Patients were assessed on admission and this included the patients ASA grade [7], mental test score [8] and a mobility score [9,10]. Surgery was undertaken or supervised by a single surgeon ([4_TD$IF]MJP). All patients received low molecular weight heparin from admission for approximately 14 days. Any complications that occurred after surgery were recorded. After discharge surviving patients were initially reviewed in a hip fracture clinic at six weeks from discharge and then completed a telephone assessment at 1 year from injury.
* Corresponding author at: Peterborough and Stamford Hospital NHS Foundation Trust, Peterborough City Hospital, CBU PO Box 211, Core C, Bretton Gate, Peterborough PE3 9GZ, United Kingdom. Tel.: +44 1733 678000x1133; fax: +44 1733 678532. E-mail addresses: [email protected] (M.J. Parker), Richard.Griffi[email protected] (R. Griffiths). http://dx.doi.org/10.1016/j.injury.2015.05.004 0020–1383/ß 2015 Elsevier Ltd. All rights reserved.
M.J. Parker, R. Griffiths / Injury, Int. J. Care Injured 46 (2015) 1562–1566
The primary outcome measure for this study was mortality. Independent statistical advice for patient numbers for this study was undertaken based on data from the Cochrane review which reported a 30 day mortality of 6.8% for spinal anaesthesia versus 9.4% for general anaesthesia [5]. To detect a significant difference with minimum power threshold of 80% then an estimated number of participants would be 2520 in total (1260 in each group). These large numbers of participants was not possible for a single centre study and therefore in the absence of sufficient funding it was decided to undertake this trial as a pilot study. All participants within the study provided written consent apart from patients with dementia who were included if the assent of the next of kin was obtained. There was no blinding of trailists, participants or outcome assessors. There was no external source of funding for this study. The study had research ethics approval and approval of the hospital Research and Development Committee. Binary outcomes for the two groups were analysed using Fisher exact test and the unpaired two-tailed t-test for continuous outcomes. For the outcome of hospital stay, the data was not parametric and therefore the Mann–Whitney U-test was used. A pvalue of p < 0.05 was considered as statistically significant. All results were analysis on an intention-to-treat basis using GraphPad InStat (version 3.00 for Windows 95, GraphPad Software, San Diego, CA, USA).
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received regional anaesthesia, generally because of a change of their condition prior to surgery. 158 patients were allocated to spinal anaesthesia but for 10 patients it was not possible to achieve a satisfactory block and a general anaesthetic was given. In another 3 patients a general anaesthesia was given because of a change in the patient’s condition. 1 patient in the general anaesthesia group was lost to follow-up at 68 days from admission. 1879 patients were excluded from the study for a variety of reasons given in Fig. 1. Some patients were excluded from the study for more than one reason. The characteristics of the two groups of patients included in the study are given in Table 1. The only statistically significant difference between the two groups was an increased proportion of male patients in the general anaesthesia group (p = 0.002). 84% of anaesthetics were undertaken or directly supervised by one of 29 different consultant anaesthetists. The remaining anaesthetics were undertaken by trainees or staff grade anaesthetists. All surgical operations were undertaken of directly supervised by the lead author ([4_TD$IF]MJP). Table 2 details the outcome measures. Intraoperative hypotension was defined as a fall in systolic blood pressure of more than 40 mm for more than 5 min. Orthopaedic ward stay refers to the days spent on the admission orthopaedic ward and total hospital stay refers to the days stay on any hospital ward till discharge home. Fig. 2 details the patient survival graphically.
Results Discussion Fig. 1 details the flow pattern of participants. Between June 2007 and November 2012, 2200 patients were admitted with a hip fracture to [5_TD$IF]Peterborough District Hospital (latterly [6_TD$IF]Peterborough City Hospital). 322 of these patients consented to be involved in the [(Fig._1)TD$IG]study. 164 were allocated to general anaesthesia but 6 of these
Controversy still continues over the value of regional (spinal) versus general anaesthesia for hip fracture repair. Most anaesthetists believe there is no difference in outcome between the two techniques, and at present both methods are used with similar
Fig. 1. Details of patient included and excluded from the study; flow pattern of participants. Patients may be excluded for more than one reason.
M.J. Parker, R. Griffiths / Injury, Int. J. Care Injured 46 (2015) 1562–1566
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Table 1 Characteristics of the general anaesthesia (GA) and spinal anaesthesia groups (percentage or standard deviation).
Number Mean age [range] Number male ASA grade 1 or 2 Median ASA grade Median mental test score Mean mobility score Haemoglobin on admission (g l r 1) Consultant anaesthetist Medical conditions present Cardiac disease Respiratory disease Diabetes Residence at time of fall From own home From residential or nursing home Fall in hospital Type of fracture Intracapsular fracture Extracapsular fracture Operation Arthroplasty Sliding hip screw/plate & screws Intramedullary nail
GA
Spinal
164 83.0[59–99] 57 (34.8%) 98 (59.8%) 2 8 6.4 (2.5) 124 (16.3)
158 82.9[52–105] 30 (19.0%) 94 9 (59.5%) 2 8 6.3 (2.5) 125 (14.5)
0.91 0.0017 1.0 0.15 0.08 0.72 0.56
136 (82.9%)
134 (84.8%)
0.65
38 (23.2%) 16 (9.8%) 20 (12.2%)
39 (24.7%) 8 (5.1%) 14 (8.8%)
0.79 0.14 0.37
145 (88.4%) 17 (10.4%)
144 (91.1%) 9 (5.6%)
0.47 0.15
2 (1.2%)
Table 2 Complications and outcomes for patients who received either general anaesthesia (GA) versus spinal anaesthesia (percentage or standard deviation).
P value
5 (3.2%)
0.28
103 (61.8%) 61 (37.2%)
101 (63.9%) 57 (36.1%)
0.91 0.91
54 (32.9%) 79 (48.2%)
55 (34.8%) 70 (44.3%)
0.73 0.50
31 (18.9%)
33 (20.1%)
0.68
frequency. The National Hip Fracture Database 2013 audit for all hospitals in England treating hip fractures reported that 47% of patients received regional anaesthesia with a range between hospitals of between 2% and 98% [11]. Prior to this study comparisons between the two techniques has been made within a number of randomised studies and all these studies have been summarised within systematic reviews [4– 6]. These reviews suggest that spinal anaesthesia may have marginal benefits in a reduced risk of thrombosis, delirium and early mortality. Many of the previous randomised studies have included less than 100 patients, and often reporting on only one or two specific outcomes measures. Furthermore, many of these studies are now somewhat dated with only two studies with over 200 patients dating from the 1980s. Since[1_TD$IF] these studies were undertaken there has been little change in the technique of spinal anaesthesia other than the more aggressive treatment of hypotension. For general anaesthesia there has been a change in many of the drugs used[7_TD$IF] with an increasing use of short acting drugs. The results for twenty-two randomised trials comparing general with regional anaesthesia involving 2506 patients have been summarised in a Cochrane review [5]. Results from this review showed a tendency to a reduced one-month mortality with regional anaesthesia (53/781(6.8%) versus 78/826(9.4%)). This was of borderline statistical significance (relative risk (RR) 0.72, 95% confidence interval (CI) 0.51 to 1.00). By three month this difference in mortality was lost (86/726 (11.8%) versus 98/765 (12.8%). Only two trials reported on 1-year mortality with no significant difference between groups (80/354 (22.6%) versus 78/ 372 (21.0%)). This study showed a small tendency to a reduced early mortality from spinal anaesthesia, which may have been more apparent, had larger number of patients been included. The difference in 1-year mortality between the two groups in this study with a lower mortality for those who received a general anaesthetic was of questionable statistical significance. We feel the difference in this study is more likely to be a chance finding related to the limited patient numbers, rather than an outcome
GA Surgical outcomes Length of anaesthesia (minutes) Intra operative hypotension Mean units blood transfused Number of patients transfused General complications Pneumonia Pulmonary embolism Deep vein thrombosis Post-operative delirium Urine retention Myocardial infarction Cerebrovascular accident Congestive cardiac failure Cardiac arrhythmia Acute renal failure Gastrointestinal bleed Pressure sores Wound infection Hospital stay Mean orthopaedic ward stay (days) Mean total hospital stay (days) Discharged to same residence Mortality Died by 30 days Died by 90 days Died by 120 days Died by 1 year
Spinal
64.8 (18.1) 17 (10.4%) 0.35 (0.81) 28 (17.1%) 3 2 3 0 8 1 0 1 3 2 0 2 2
(1.8%) (1.2%) (1.8%) (4.9%) (0.6%) (0.6%) (1.8%) (1.2%) (1.2%) (1.2%)
65.5 (16.9) 9 (5.6%) 0.35 (0.74) 30 (19.0%) 2 0 1 3 1 1 0 0 0 0 1 2 3
(1.3%)
p value 0.72 0.15 1.0 0.67
(0.6%) (1.9%) (0.6%) (0.6%)
1.0 0.50 0.62 0.25 0.04 1.0
(0.6%) (1.3%) (1.9%)
1.0 0.25 0.50 1.0 1.0 0.68
14.1 (9.3)
15.0 (11.9)
0.95
15.9 (13.7)
16.2 (14.6)
0.75
150 (91.5%)
143 (90.5%)
0.85
8 12 12 19
(4.9%) (7.3%) (7.3%) (11.7%)
5 12 15 32
(3.2%) (7.6%) (9.5%) (20.2%)
0.57 1.00 0.55 0.05
related to the anaesthetic technique. It is difficult to explain why a difference in anaesthetic technique that does not affect 30 day mortality can influence mortality at later time periods. The Cochrane review reported that regional anaesthesia was associated with a reduced risk of deep venous thrombosis (RR 0.64, 95% CI: 0.48–0.86) [5]. However, this finding was considered insecure due to possible selection bias in the subgroups in which this outcome was measured. This study found a small reduction in the numbers of thrombotic complications for those that received regional anaesthesia (5 cases versus 1 case, p value 0.21) which may provide some support for this finding. Within the Cochrane review, regional anaesthesia was also associated with a marginally reduced risk of acute post-operative delirium (RR 0.50, 95% CI: 0.26–0.95). This study was not able to support this finding. The number of patients included within this study was too small to make any definite conclusions on the overall outcomes and differences between the two techniques. Mortality was the primary outcome for this study and a power calculation, based on the data from the Cochrane review indicated that at least 2500 patients would be needed within such a randomised trial. This study has been planned to recruit 600 patients but we were only able to recruit 322 patients within the time frame of this study. A significant number of patients were excluded for the reasons detailed in Fig. 1. This study was set up as a pilot study to determine if there was any trend to a difference in mortality and to add the data to previous studies on this topic. With 322 patients recruited it still represents the third largest randomised trial in this patient group to date. The aim of the study was to stimulate the development of a large multicentre trial on this topic had a trend to notable differences in outcome between groups been demonstrated. This study included patients with a wide variant of comorbidities and a number of different hip fracture operations. It is possible that a particular subgroup of patients or those with a
[(Fig._2)TD$IG]
M.J. Parker, R. Griffiths / Injury, Int. J. Care Injured 46 (2015) 1562–1566
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Fig. 2. Kaplain Meir survival curve for the two groups.
specific surgical procedure may be better managed with specific form of anaesthesia. Unfortunately the limited patient’s numbers within this study precluded such an analysis. Those patients with a specific co-morbidity, which in the anaesthetists opinion, indicated a specific type of anaesthesia had to excluded from this study as detailed in Fig. 1. Other potential biases within this study may be related to the large number of patients excluded (Fig. 1). Most of the exclusions were due to administrative reasons of the lead trialist being away or lack of consent/assent. A further 294 patients expressed a preference for the type of anaesthesia used, this was mainly preferring general anaesthesia. Other exclusions were because the anaesthetist felt the patients’ medical conditions dictated that in their opinion one method of anaesthesia was preferable. Being a single centre study this may introduce potential biases which would be less in a larger multicentre study. A further potential bias with the study was the increased proportion of male patients entered into the general anaesthesia group. Mortality has been reported to be higher in male patients after a hip fracture [12]. This study used an intention to treat analysis, which meant that once randomised patients results were all analysed for the group to which the patient was allocated. It is possible that those patients that have a change in their type of anaesthesia may be frailer to the group as a whole due to either an unstable medical condition, or
being a patient with more spinal collapse that precluded accessing the spinal canal. For this reason it is appropriate to keep these patients within the group to which they were originally allocated. The 30 day mortality excluding the 19 patients who did not have the type of anaesthesia to which they were allocated showed no statistically significant difference (7/158(3.9%) versus 4/ 145(2.7%)). For the 1 year mortality exclusion of the 19 patients increased the difference in mortality in favour of the GA group ([8_TD$IF]17/ 158(10.8%) versus 29/145(20.0%), p value = 0.04). In summary this randomised controlled trial failed to find any notable differences in outcome between the techniques of regional or spinal anaesthesia for hip fracture surgery. It therefore suggests that for those patients in whom there is no pre-existing condition that dictates the choice of anaesthesia, either method may be used. Further large multi-centre randomised trials on this topic or analysis of large patient datasets and appropriate subgroups are indicated to determine if one particular method of anaesthesia is more appropriate for specific patient groups or surgical procedures. Funding The study was funded from the Peterborough Hospitals Hip Fracture Fund.
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Conflict of interest The authors declare that they have no conflict of interest in connection with this paper[2_TD$IF]. References
[5] [6]
[7] [8]
[1] Gullberg B, Johnell O, Kanis JA. World-wide projections for hip fracture. Osteoporos Int 1997;7:407–13. [2] Brophy S, John G, Evans E, Lyons RA. Methodological issues in the identification of hip fractures using routine hospital data: a database study. Osteoporos Int 2009;69:1573–9. [3] White SM, Griffiths R. Projected incidence of proximal femoral fracture in England: a report from the NHS Hip Fracture Anaesthesia Network (NIPFAN). Injury 2011;42:1230–3. [4] Luger TJ, Kammerlandeer C, Gosch M, Luger MF, Kammerlander-Knauer U, Roth T, Kreutziger. Neuroaxial versus general anaesthesia in geriatric patients
[9] [10]
[11] [12]
for hip fracture surgery: does it matter? Osteoporos Int 2010;21(Suppl. 4): S555–72. Parker MJ, Handoll HHG, Griffiths R. Anaesthesia for hip fracture surgery in adults. Cochrane Database Syst Rev 2004;4:CD000521. Rodgers A, Walker N, Schug S, McKee A, Kehlet H, van Zundert A, et al. Reduction of postoperative mortality and morbidity with epidural or spinal anaesthesia: results from overview of randomised trials. Br Med J 2000;321:1493–7. American Society of Anaesthesiologists. New classification of physical status. Anaesthesiology 1963;24:111. Qureshi KN, Hodkinson HM. Evaluation of a ten-question mental test in the institutionalised elderly. Age Ageing 1974;3:152–7. Parker MJ, Palmer CR. A new mobility score for predicting mortality after hip fracture. J Bone Joint Surg [Br] 1993;75-B:797–8. Kristensen MT, Bandholm T, Foss NB, Ekdahl C, Kehlet H. High inter-tester reliability of the new mobility score in patients with hip fracture. J Rehabil Med 2008;40:589–91. National Hip Fracture Database; National report 2013. www.nhfd.co.uk. Hu F, Jiang C, Shen J, Tang P, Wang Y. Preoperative predictors for mortality following hip fracture surgery: a systematic review and meta-analysis. Injury 2012;43:676–85.
Contents lists available at ScienceDirect
Injury journal homepage: www.elsevier.com/locate/injury
General versus regional anaesthesia for hip fractures. A pilot randomised controlled trial of 322 patients Martyn J. Parker a,*, Richard Griffiths b a b
Department of Orthopaedics, Peterborough and Stamford Hospital NHS Foundation Trust, Peterborough City Hospital, United Kingdom Department of Anaesthesia, Peterborough and Stamford Hospital NHS Foundation Trust, Peterborough City Hospital, United Kingdom
A R T I C L E I N F O
A B S T R A C T
Article history: Accepted 1 May 2015
Uncertainty remains regarding the optimum method of anaesthesia for hip fracture surgery. We randomised 322 patients with a hip fracture to receive either general anaesthesia or regional (spinal) anaesthesia. Surviving patients were followed up to 1 year from injury. There was no notable difference in the outcomes of hospital stay, need for blood transfusion or post-operative complications between groups. 30-day mortality was marginally reduced for spinal anaesthesia 7/164(4.3%) versus 5/158(3.2%) (p = 0.57), whilst at 1 year it was less for general anaesthesia 20/163(12.1%) versus 32/158(20.2%) (p = 0.05). Within the confines of the limited patient numbers studied we conclude that there are no marked differences in outcome between the two techniques. ß 2015 Elsevier Ltd. All rights reserved.
Keywords: Hip fracture Anaesthesia Randomised trial
Introduction
Patients and methods
At present about 1.5 million hip fractures occur each year around the world with numbers predicted increase to between 7 and 21 million by 2050 [1]. In the UK the incidence is about 77,000 [2]. The number of hip fractures in England is expected to reach 100,000 by the year 2033 [[3_TD$IF]3]. The majority of these fractures are treated surgically requiring some form of anaesthesia. Despite the frequent nature of the condition controversy still exists regarding the optimum choice of anaesthesia [4–6]. For specific groups of patients one particular type of anaesthesia may be preferred. For example those with chest disease are felt to be better treated with spinal anaesthesia, whilst for those on warfarin general anaesthesia (GA) is more likely to be chosen. There remains a substantial proportion of patients for which either technique may be used. This study aims to revisit this controversy by randomising 322 patients with a hip fracture to either regional or general anaesthesia to see if there is any suggestion of a significant benefit for either technique.
The protocol for this study is that it only included those patients aged over 49 years of age presenting to one hospital with an acute hip fracture. Discussion with study participants was undertaken by the lead trialist ([4_TD$IF]MJP). Patient with dementia were included if their next was willing to allow their relative to participate in the study. Patients with more than one injury were included within the study if spinal anaesthesia was suitable for all necessary surgical procedures. Patients who expressed a preference to a particular method of anaesthesia were excluded at their request. In addition those patients in whom either the attending anaesthetist or surgeon felt either technique was more appropriate were also excluded. Randomisation was undertaken by the opening of sealed opaque numbered envelopes, which were prepared at the start of the study by a person independent to the trial. Each envelope contained details of the type of anaesthesia to be given (general versus spinal anaesthesia). The exact technique and doses of drugs used for the different types of anaesthesia was the choice of the anaesthetist. Patients were assessed on admission and this included the patients ASA grade [7], mental test score [8] and a mobility score [9,10]. Surgery was undertaken or supervised by a single surgeon ([4_TD$IF]MJP). All patients received low molecular weight heparin from admission for approximately 14 days. Any complications that occurred after surgery were recorded. After discharge surviving patients were initially reviewed in a hip fracture clinic at six weeks from discharge and then completed a telephone assessment at 1 year from injury.
* Corresponding author at: Peterborough and Stamford Hospital NHS Foundation Trust, Peterborough City Hospital, CBU PO Box 211, Core C, Bretton Gate, Peterborough PE3 9GZ, United Kingdom. Tel.: +44 1733 678000x1133; fax: +44 1733 678532. E-mail addresses: [email protected] (M.J. Parker), Richard.Griffi[email protected] (R. Griffiths). http://dx.doi.org/10.1016/j.injury.2015.05.004 0020–1383/ß 2015 Elsevier Ltd. All rights reserved.
M.J. Parker, R. Griffiths / Injury, Int. J. Care Injured 46 (2015) 1562–1566
The primary outcome measure for this study was mortality. Independent statistical advice for patient numbers for this study was undertaken based on data from the Cochrane review which reported a 30 day mortality of 6.8% for spinal anaesthesia versus 9.4% for general anaesthesia [5]. To detect a significant difference with minimum power threshold of 80% then an estimated number of participants would be 2520 in total (1260 in each group). These large numbers of participants was not possible for a single centre study and therefore in the absence of sufficient funding it was decided to undertake this trial as a pilot study. All participants within the study provided written consent apart from patients with dementia who were included if the assent of the next of kin was obtained. There was no blinding of trailists, participants or outcome assessors. There was no external source of funding for this study. The study had research ethics approval and approval of the hospital Research and Development Committee. Binary outcomes for the two groups were analysed using Fisher exact test and the unpaired two-tailed t-test for continuous outcomes. For the outcome of hospital stay, the data was not parametric and therefore the Mann–Whitney U-test was used. A pvalue of p < 0.05 was considered as statistically significant. All results were analysis on an intention-to-treat basis using GraphPad InStat (version 3.00 for Windows 95, GraphPad Software, San Diego, CA, USA).
1563
received regional anaesthesia, generally because of a change of their condition prior to surgery. 158 patients were allocated to spinal anaesthesia but for 10 patients it was not possible to achieve a satisfactory block and a general anaesthetic was given. In another 3 patients a general anaesthesia was given because of a change in the patient’s condition. 1 patient in the general anaesthesia group was lost to follow-up at 68 days from admission. 1879 patients were excluded from the study for a variety of reasons given in Fig. 1. Some patients were excluded from the study for more than one reason. The characteristics of the two groups of patients included in the study are given in Table 1. The only statistically significant difference between the two groups was an increased proportion of male patients in the general anaesthesia group (p = 0.002). 84% of anaesthetics were undertaken or directly supervised by one of 29 different consultant anaesthetists. The remaining anaesthetics were undertaken by trainees or staff grade anaesthetists. All surgical operations were undertaken of directly supervised by the lead author ([4_TD$IF]MJP). Table 2 details the outcome measures. Intraoperative hypotension was defined as a fall in systolic blood pressure of more than 40 mm for more than 5 min. Orthopaedic ward stay refers to the days spent on the admission orthopaedic ward and total hospital stay refers to the days stay on any hospital ward till discharge home. Fig. 2 details the patient survival graphically.
Results Discussion Fig. 1 details the flow pattern of participants. Between June 2007 and November 2012, 2200 patients were admitted with a hip fracture to [5_TD$IF]Peterborough District Hospital (latterly [6_TD$IF]Peterborough City Hospital). 322 of these patients consented to be involved in the [(Fig._1)TD$IG]study. 164 were allocated to general anaesthesia but 6 of these
Controversy still continues over the value of regional (spinal) versus general anaesthesia for hip fracture repair. Most anaesthetists believe there is no difference in outcome between the two techniques, and at present both methods are used with similar
Fig. 1. Details of patient included and excluded from the study; flow pattern of participants. Patients may be excluded for more than one reason.
M.J. Parker, R. Griffiths / Injury, Int. J. Care Injured 46 (2015) 1562–1566
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Table 1 Characteristics of the general anaesthesia (GA) and spinal anaesthesia groups (percentage or standard deviation).
Number Mean age [range] Number male ASA grade 1 or 2 Median ASA grade Median mental test score Mean mobility score Haemoglobin on admission (g l r 1) Consultant anaesthetist Medical conditions present Cardiac disease Respiratory disease Diabetes Residence at time of fall From own home From residential or nursing home Fall in hospital Type of fracture Intracapsular fracture Extracapsular fracture Operation Arthroplasty Sliding hip screw/plate & screws Intramedullary nail
GA
Spinal
164 83.0[59–99] 57 (34.8%) 98 (59.8%) 2 8 6.4 (2.5) 124 (16.3)
158 82.9[52–105] 30 (19.0%) 94 9 (59.5%) 2 8 6.3 (2.5) 125 (14.5)
0.91 0.0017 1.0 0.15 0.08 0.72 0.56
136 (82.9%)
134 (84.8%)
0.65
38 (23.2%) 16 (9.8%) 20 (12.2%)
39 (24.7%) 8 (5.1%) 14 (8.8%)
0.79 0.14 0.37
145 (88.4%) 17 (10.4%)
144 (91.1%) 9 (5.6%)
0.47 0.15
2 (1.2%)
Table 2 Complications and outcomes for patients who received either general anaesthesia (GA) versus spinal anaesthesia (percentage or standard deviation).
P value
5 (3.2%)
0.28
103 (61.8%) 61 (37.2%)
101 (63.9%) 57 (36.1%)
0.91 0.91
54 (32.9%) 79 (48.2%)
55 (34.8%) 70 (44.3%)
0.73 0.50
31 (18.9%)
33 (20.1%)
0.68
frequency. The National Hip Fracture Database 2013 audit for all hospitals in England treating hip fractures reported that 47% of patients received regional anaesthesia with a range between hospitals of between 2% and 98% [11]. Prior to this study comparisons between the two techniques has been made within a number of randomised studies and all these studies have been summarised within systematic reviews [4– 6]. These reviews suggest that spinal anaesthesia may have marginal benefits in a reduced risk of thrombosis, delirium and early mortality. Many of the previous randomised studies have included less than 100 patients, and often reporting on only one or two specific outcomes measures. Furthermore, many of these studies are now somewhat dated with only two studies with over 200 patients dating from the 1980s. Since[1_TD$IF] these studies were undertaken there has been little change in the technique of spinal anaesthesia other than the more aggressive treatment of hypotension. For general anaesthesia there has been a change in many of the drugs used[7_TD$IF] with an increasing use of short acting drugs. The results for twenty-two randomised trials comparing general with regional anaesthesia involving 2506 patients have been summarised in a Cochrane review [5]. Results from this review showed a tendency to a reduced one-month mortality with regional anaesthesia (53/781(6.8%) versus 78/826(9.4%)). This was of borderline statistical significance (relative risk (RR) 0.72, 95% confidence interval (CI) 0.51 to 1.00). By three month this difference in mortality was lost (86/726 (11.8%) versus 98/765 (12.8%). Only two trials reported on 1-year mortality with no significant difference between groups (80/354 (22.6%) versus 78/ 372 (21.0%)). This study showed a small tendency to a reduced early mortality from spinal anaesthesia, which may have been more apparent, had larger number of patients been included. The difference in 1-year mortality between the two groups in this study with a lower mortality for those who received a general anaesthetic was of questionable statistical significance. We feel the difference in this study is more likely to be a chance finding related to the limited patient numbers, rather than an outcome
GA Surgical outcomes Length of anaesthesia (minutes) Intra operative hypotension Mean units blood transfused Number of patients transfused General complications Pneumonia Pulmonary embolism Deep vein thrombosis Post-operative delirium Urine retention Myocardial infarction Cerebrovascular accident Congestive cardiac failure Cardiac arrhythmia Acute renal failure Gastrointestinal bleed Pressure sores Wound infection Hospital stay Mean orthopaedic ward stay (days) Mean total hospital stay (days) Discharged to same residence Mortality Died by 30 days Died by 90 days Died by 120 days Died by 1 year
Spinal
64.8 (18.1) 17 (10.4%) 0.35 (0.81) 28 (17.1%) 3 2 3 0 8 1 0 1 3 2 0 2 2
(1.8%) (1.2%) (1.8%) (4.9%) (0.6%) (0.6%) (1.8%) (1.2%) (1.2%) (1.2%)
65.5 (16.9) 9 (5.6%) 0.35 (0.74) 30 (19.0%) 2 0 1 3 1 1 0 0 0 0 1 2 3
(1.3%)
p value 0.72 0.15 1.0 0.67
(0.6%) (1.9%) (0.6%) (0.6%)
1.0 0.50 0.62 0.25 0.04 1.0
(0.6%) (1.3%) (1.9%)
1.0 0.25 0.50 1.0 1.0 0.68
14.1 (9.3)
15.0 (11.9)
0.95
15.9 (13.7)
16.2 (14.6)
0.75
150 (91.5%)
143 (90.5%)
0.85
8 12 12 19
(4.9%) (7.3%) (7.3%) (11.7%)
5 12 15 32
(3.2%) (7.6%) (9.5%) (20.2%)
0.57 1.00 0.55 0.05
related to the anaesthetic technique. It is difficult to explain why a difference in anaesthetic technique that does not affect 30 day mortality can influence mortality at later time periods. The Cochrane review reported that regional anaesthesia was associated with a reduced risk of deep venous thrombosis (RR 0.64, 95% CI: 0.48–0.86) [5]. However, this finding was considered insecure due to possible selection bias in the subgroups in which this outcome was measured. This study found a small reduction in the numbers of thrombotic complications for those that received regional anaesthesia (5 cases versus 1 case, p value 0.21) which may provide some support for this finding. Within the Cochrane review, regional anaesthesia was also associated with a marginally reduced risk of acute post-operative delirium (RR 0.50, 95% CI: 0.26–0.95). This study was not able to support this finding. The number of patients included within this study was too small to make any definite conclusions on the overall outcomes and differences between the two techniques. Mortality was the primary outcome for this study and a power calculation, based on the data from the Cochrane review indicated that at least 2500 patients would be needed within such a randomised trial. This study has been planned to recruit 600 patients but we were only able to recruit 322 patients within the time frame of this study. A significant number of patients were excluded for the reasons detailed in Fig. 1. This study was set up as a pilot study to determine if there was any trend to a difference in mortality and to add the data to previous studies on this topic. With 322 patients recruited it still represents the third largest randomised trial in this patient group to date. The aim of the study was to stimulate the development of a large multicentre trial on this topic had a trend to notable differences in outcome between groups been demonstrated. This study included patients with a wide variant of comorbidities and a number of different hip fracture operations. It is possible that a particular subgroup of patients or those with a
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Fig. 2. Kaplain Meir survival curve for the two groups.
specific surgical procedure may be better managed with specific form of anaesthesia. Unfortunately the limited patient’s numbers within this study precluded such an analysis. Those patients with a specific co-morbidity, which in the anaesthetists opinion, indicated a specific type of anaesthesia had to excluded from this study as detailed in Fig. 1. Other potential biases within this study may be related to the large number of patients excluded (Fig. 1). Most of the exclusions were due to administrative reasons of the lead trialist being away or lack of consent/assent. A further 294 patients expressed a preference for the type of anaesthesia used, this was mainly preferring general anaesthesia. Other exclusions were because the anaesthetist felt the patients’ medical conditions dictated that in their opinion one method of anaesthesia was preferable. Being a single centre study this may introduce potential biases which would be less in a larger multicentre study. A further potential bias with the study was the increased proportion of male patients entered into the general anaesthesia group. Mortality has been reported to be higher in male patients after a hip fracture [12]. This study used an intention to treat analysis, which meant that once randomised patients results were all analysed for the group to which the patient was allocated. It is possible that those patients that have a change in their type of anaesthesia may be frailer to the group as a whole due to either an unstable medical condition, or
being a patient with more spinal collapse that precluded accessing the spinal canal. For this reason it is appropriate to keep these patients within the group to which they were originally allocated. The 30 day mortality excluding the 19 patients who did not have the type of anaesthesia to which they were allocated showed no statistically significant difference (7/158(3.9%) versus 4/ 145(2.7%)). For the 1 year mortality exclusion of the 19 patients increased the difference in mortality in favour of the GA group ([8_TD$IF]17/ 158(10.8%) versus 29/145(20.0%), p value = 0.04). In summary this randomised controlled trial failed to find any notable differences in outcome between the techniques of regional or spinal anaesthesia for hip fracture surgery. It therefore suggests that for those patients in whom there is no pre-existing condition that dictates the choice of anaesthesia, either method may be used. Further large multi-centre randomised trials on this topic or analysis of large patient datasets and appropriate subgroups are indicated to determine if one particular method of anaesthesia is more appropriate for specific patient groups or surgical procedures. Funding The study was funded from the Peterborough Hospitals Hip Fracture Fund.
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Conflict of interest The authors declare that they have no conflict of interest in connection with this paper[2_TD$IF]. References
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