Int Urogynecol J DOI 10.1007/s00192-015-2670-4
ORIGINAL ARTICLE
General or Spinal Anaesthetic for Vaginal Surgery in Pelvic Floor Disorders (GOSSIP): a feasibility randomised controlled trial B. Purwar & K. M. Ismail & N. Turner & A. Farrell & M. Verzune & M. Annappa & I. Smith & Zeiad El-Gizawy & J. C. Cooper
Received: 12 October 2014 / Accepted: 24 February 2015 # The International Urogynecological Association 2015
Abstract Introduction and hypothesis Spinal anaesthesia (SA) and general anaesthesia (GA) are widely used techniques for vaginal surgery for pelvic floor disorders with inconclusive evidence of the superiority of either. We conducted a randomised controlled trial (RCT) to assess the feasibility of a full scale RCT aiming to examine the effect of anaesthetic mode for vaginal surgery on operative, patient reported and length of hospital stay (LOHS) outcomes. Methods Patients undergoing vaginal surgery, recruited through a urogynaecology service in a University teaching hospital, were randomised to receive either GA or SA. Patients were followed up for 12 weeks postoperatively. Pain was measured on a visual analogue scale; nausea was assessed with a four-point verbal rating scale. Patient’s subjective
B. Purwar : M. Verzune : Z. El-Gizawy : J. C. Cooper (*) Department of Obstetrics and Gynaecology, Royal Stoke University Hospital, Newcastle Road, Stoke-on-Trent, Staffordshire ST4 6QG, UK e-mail: [email protected] K. M. Ismail The Birmingham Centre for Women’s and Children’s Health, School of Clinical and Experimental Medicine, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK K. M. Ismail Academic Unit, Birmingham Women’s NHS Foundation Trust, Edgbaston, Birmingham B15 2TG, UK N. Turner : A. Farrell : I. Smith Department of Anaesthesia, Royal Stoke University Hospital, Staffordshire, UK M. Annappa Department of Obstetrics and Gynaecology, Diana, Princess of Wales Hospital, Bridgend, UK
perception of treatment outcome, quality of life (QoL) and functional outcomes were assessed using the International Consultation on Incontinence Modular Questionnaire (ICIQ) on vaginal symptoms and the SF-36 questionnaire. Results Sixty women were randomised, 29 to GA and 31 to SA. The groups were similar in terms of age and type of vaginal surgery performed. No statistically significant differences were noted between the groups with regard to pain, nausea, quality of life (QoL), functional outcomes as well as length of stay in the postoperative recovery room, use of analgesia postoperatively and LOHS. Conclusion This study has demonstrated that a full RCT is feasible and should focus on the length of hospital stay in a subgroup of patients undergoing vaginal surgery where SA may help to facilitate enhanced recovery or day surgery. Keywords General anaesthesia . Spinal anaesthesia . Transvaginal tape . Vaginal hysterectomy . Vaginal repair
Introduction Vaginal prolapse and urinary incontinence are common gynaecological disorders, with a reported estimated prevalence ranging from 3 to 50 %, depending on the definition used [1], and 30–50 % [2] respectively in older age groups. Surgery for prolapse and sling procedures for stress urinary incontinence are amongst the most commonly performed urogynaecological procedures in women [3]. Indeed, in the USA over 300,000 prolapse operations are performed each year [4] at a cost of 1 billion USD [1], while in the UK there were over 340,00 pelvic floor episodes recorded between 2002 and 2008 [3]. Contemporary research into predictors of vaginal surgery outcomes has revolved around patient characteristics, illness severity, comorbidities, surgical procedures and techniques.
Int Urogynecol J
Nevertheless, determinants of surgical outcomes are multifactorial and include perioperative care as well as anaesthetic management [5]. Spinal anaesthesia (SA) and general anaesthesia (GA) are widely used techniques for vaginal surgery. Each has been shown to have distinct benefits and disadvantages in other populations [6], but the evidence remains inconclusive with regards to the long-term outcomes following vaginal surgery. For example, SA was shown to improve early pain and nausea after vaginal hysterectomy, but had no effect on functional status at 12 weeks [7]. Evidence of the impact of anaesthesia on functional and clinical outcomes following other types of vaginal surgery is lacking. We therefore designed and conducted a randomised controlled trial (RCT) to assess the feasibility of a full scale RCT aiming to examine the effect of anaesthetic mode for vaginal surgery (SA versus GA) on operative, patient reported and length of hospital stay (LOHS) outcomes.
Premedication and monitoring
Materials and methods
SA protocol
This feasibility trial was conducted at a University teaching hospital in the UK between February 2012 and May 2013. Ethical approval was obtained from the national research ethics service committee, West Midlands, UK (reference 11/ WM/0044) and the trial was registered on the International Standard Randomised Controlled Trial Number Register (registration number: ISRCTN76637086). The study was carried out following the CONSORT recommendations for randomised, clinical trials.
In the SA group, a 25 G Whitacre needle was inserted at the L3–L4 interspace following skin infiltration with 1 % lidocaine, under aseptic conditions, the patient in the sitting position. Initially, the SA regimen consisted of 1 ml of 0.5 % hyperbaric bupivacaine with 10 µg of fentanyl diluted to a volume of 3.0 ml using normal saline [8]. Patients remained in the sitting position for 5 min following the introduction of SA. However, owing to sub-optimal pain control in the first few patients, the protocol was revised and the spinal anaesthetic mixture was amended to 2.0 ml 0.5 % heavy bupivacaine with 10 µg fentanyl, diluted to 3 ml, with the patient’s position immediately changed to semi-recumbent following spinal injection.
Patient selection and consent Potential study participants listed for vaginal prolapse or incontinence surgical procedures were identified through a specialised urogynaecology service. There was no age restriction for inclusion. Exclusion criteria were an American Society of Anesthesiologists (ASA) grade 3, contraindication to SA, a lack of capacity to provide consent and an inability to read and write in English. Eligible women were provided with written information about the study and valid consent to participate was obtained on the day of surgery by the operating team from those who wished to participate. Once informed consent was obtained, women were randomised to receive either GA or SA. An internet-based sequence allocation randomisation was carried out by the Nottingham (UK) Clinical Trials Support Unit with random permuted blocks of randomly varying size. The anaesthetist was informed of the random allocation allocated by the computer. Owing to the nature of the interventions, it was not possible to blind either patients or the assessing team to the intervention given.
Premedication of sustained release ibuprofen 1,600 mg and paracetamol 1G was given approximately 60 min before surgery. Intravenous access was established with a 20 G cannula in both groups and Hartmann’s solution infused at a rate of 500 ml/h during surgery. Non-invasive blood pressure, electrocardiogram, pulse-oximetry and capnography (GA patients only) were applied in the anaesthetic room and monitored throughout the operation. GA protocol In the GA group, anaesthesia was induced with propofol (3 mg/kg) and maintained with isoflurane in oxygenenriched air to achieve an inspired oxygen fraction (FiO2) of 33 %. Ondansetron 4 mg IV was given as prophylaxis against postoperative nausea and vomiting (PONV).
Intraoperative management The operating surgeon was a urogynaecology consultant (JC) or specialist trainee signed off as competent for independent practice for the type of surgery performed. Anaesthesia was provided by one of two anaesthetic specialists (NT or AF). In both groups, anaesthesia was augmented by surgical infiltration with local anaesthetic solution comprising 30 ml of 0.5 % levobupivacaine, 27 ml of normal saline and 3 ml of adrenaline 1:10,000. In both groups, hypotension (systolic BP
ORIGINAL ARTICLE
General or Spinal Anaesthetic for Vaginal Surgery in Pelvic Floor Disorders (GOSSIP): a feasibility randomised controlled trial B. Purwar & K. M. Ismail & N. Turner & A. Farrell & M. Verzune & M. Annappa & I. Smith & Zeiad El-Gizawy & J. C. Cooper
Received: 12 October 2014 / Accepted: 24 February 2015 # The International Urogynecological Association 2015
Abstract Introduction and hypothesis Spinal anaesthesia (SA) and general anaesthesia (GA) are widely used techniques for vaginal surgery for pelvic floor disorders with inconclusive evidence of the superiority of either. We conducted a randomised controlled trial (RCT) to assess the feasibility of a full scale RCT aiming to examine the effect of anaesthetic mode for vaginal surgery on operative, patient reported and length of hospital stay (LOHS) outcomes. Methods Patients undergoing vaginal surgery, recruited through a urogynaecology service in a University teaching hospital, were randomised to receive either GA or SA. Patients were followed up for 12 weeks postoperatively. Pain was measured on a visual analogue scale; nausea was assessed with a four-point verbal rating scale. Patient’s subjective
B. Purwar : M. Verzune : Z. El-Gizawy : J. C. Cooper (*) Department of Obstetrics and Gynaecology, Royal Stoke University Hospital, Newcastle Road, Stoke-on-Trent, Staffordshire ST4 6QG, UK e-mail: [email protected] K. M. Ismail The Birmingham Centre for Women’s and Children’s Health, School of Clinical and Experimental Medicine, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK K. M. Ismail Academic Unit, Birmingham Women’s NHS Foundation Trust, Edgbaston, Birmingham B15 2TG, UK N. Turner : A. Farrell : I. Smith Department of Anaesthesia, Royal Stoke University Hospital, Staffordshire, UK M. Annappa Department of Obstetrics and Gynaecology, Diana, Princess of Wales Hospital, Bridgend, UK
perception of treatment outcome, quality of life (QoL) and functional outcomes were assessed using the International Consultation on Incontinence Modular Questionnaire (ICIQ) on vaginal symptoms and the SF-36 questionnaire. Results Sixty women were randomised, 29 to GA and 31 to SA. The groups were similar in terms of age and type of vaginal surgery performed. No statistically significant differences were noted between the groups with regard to pain, nausea, quality of life (QoL), functional outcomes as well as length of stay in the postoperative recovery room, use of analgesia postoperatively and LOHS. Conclusion This study has demonstrated that a full RCT is feasible and should focus on the length of hospital stay in a subgroup of patients undergoing vaginal surgery where SA may help to facilitate enhanced recovery or day surgery. Keywords General anaesthesia . Spinal anaesthesia . Transvaginal tape . Vaginal hysterectomy . Vaginal repair
Introduction Vaginal prolapse and urinary incontinence are common gynaecological disorders, with a reported estimated prevalence ranging from 3 to 50 %, depending on the definition used [1], and 30–50 % [2] respectively in older age groups. Surgery for prolapse and sling procedures for stress urinary incontinence are amongst the most commonly performed urogynaecological procedures in women [3]. Indeed, in the USA over 300,000 prolapse operations are performed each year [4] at a cost of 1 billion USD [1], while in the UK there were over 340,00 pelvic floor episodes recorded between 2002 and 2008 [3]. Contemporary research into predictors of vaginal surgery outcomes has revolved around patient characteristics, illness severity, comorbidities, surgical procedures and techniques.
Int Urogynecol J
Nevertheless, determinants of surgical outcomes are multifactorial and include perioperative care as well as anaesthetic management [5]. Spinal anaesthesia (SA) and general anaesthesia (GA) are widely used techniques for vaginal surgery. Each has been shown to have distinct benefits and disadvantages in other populations [6], but the evidence remains inconclusive with regards to the long-term outcomes following vaginal surgery. For example, SA was shown to improve early pain and nausea after vaginal hysterectomy, but had no effect on functional status at 12 weeks [7]. Evidence of the impact of anaesthesia on functional and clinical outcomes following other types of vaginal surgery is lacking. We therefore designed and conducted a randomised controlled trial (RCT) to assess the feasibility of a full scale RCT aiming to examine the effect of anaesthetic mode for vaginal surgery (SA versus GA) on operative, patient reported and length of hospital stay (LOHS) outcomes.
Premedication and monitoring
Materials and methods
SA protocol
This feasibility trial was conducted at a University teaching hospital in the UK between February 2012 and May 2013. Ethical approval was obtained from the national research ethics service committee, West Midlands, UK (reference 11/ WM/0044) and the trial was registered on the International Standard Randomised Controlled Trial Number Register (registration number: ISRCTN76637086). The study was carried out following the CONSORT recommendations for randomised, clinical trials.
In the SA group, a 25 G Whitacre needle was inserted at the L3–L4 interspace following skin infiltration with 1 % lidocaine, under aseptic conditions, the patient in the sitting position. Initially, the SA regimen consisted of 1 ml of 0.5 % hyperbaric bupivacaine with 10 µg of fentanyl diluted to a volume of 3.0 ml using normal saline [8]. Patients remained in the sitting position for 5 min following the introduction of SA. However, owing to sub-optimal pain control in the first few patients, the protocol was revised and the spinal anaesthetic mixture was amended to 2.0 ml 0.5 % heavy bupivacaine with 10 µg fentanyl, diluted to 3 ml, with the patient’s position immediately changed to semi-recumbent following spinal injection.
Patient selection and consent Potential study participants listed for vaginal prolapse or incontinence surgical procedures were identified through a specialised urogynaecology service. There was no age restriction for inclusion. Exclusion criteria were an American Society of Anesthesiologists (ASA) grade 3, contraindication to SA, a lack of capacity to provide consent and an inability to read and write in English. Eligible women were provided with written information about the study and valid consent to participate was obtained on the day of surgery by the operating team from those who wished to participate. Once informed consent was obtained, women were randomised to receive either GA or SA. An internet-based sequence allocation randomisation was carried out by the Nottingham (UK) Clinical Trials Support Unit with random permuted blocks of randomly varying size. The anaesthetist was informed of the random allocation allocated by the computer. Owing to the nature of the interventions, it was not possible to blind either patients or the assessing team to the intervention given.
Premedication of sustained release ibuprofen 1,600 mg and paracetamol 1G was given approximately 60 min before surgery. Intravenous access was established with a 20 G cannula in both groups and Hartmann’s solution infused at a rate of 500 ml/h during surgery. Non-invasive blood pressure, electrocardiogram, pulse-oximetry and capnography (GA patients only) were applied in the anaesthetic room and monitored throughout the operation. GA protocol In the GA group, anaesthesia was induced with propofol (3 mg/kg) and maintained with isoflurane in oxygenenriched air to achieve an inspired oxygen fraction (FiO2) of 33 %. Ondansetron 4 mg IV was given as prophylaxis against postoperative nausea and vomiting (PONV).
Intraoperative management The operating surgeon was a urogynaecology consultant (JC) or specialist trainee signed off as competent for independent practice for the type of surgery performed. Anaesthesia was provided by one of two anaesthetic specialists (NT or AF). In both groups, anaesthesia was augmented by surgical infiltration with local anaesthetic solution comprising 30 ml of 0.5 % levobupivacaine, 27 ml of normal saline and 3 ml of adrenaline 1:10,000. In both groups, hypotension (systolic BP
