BJA
Correspondence
within the UK,4 it is important to consider ibogaine toxicity in the differential diagnosis of the acutely unwell intoxicated patient and in patients presenting with a prolonged QT interval and cardiac rhythm disturbance.
Declaration of interest None declared. I. Asua* Oxford, UK * E-mail: [email protected]
1 Alper KR, Lotsof HS, Frenken GMN, et al. Treatment of acute opiod withdrawal with ibogaine. Am J Addict 1999; 8: 234– 42 2 Mash DC, Kovera CA, Pablo J, et al. Ibogaine: complex pharmacokinetics, concerns for safety and preliminary efficacy measures. Ann N Y Acad Sci 2000; 914: 394–401 3 Hoelen DWM, Spiering W, Valk GD. Long QT syndrome induced by the antiaddiction drug ibogaine. N Engl J Med 2009; 360: 308– 9 4 BBC News Magazine, April 2012. Available at http://www.bbc.co. uk/news/magazine-17666589
doi:10.1093/bja/aet396
Sustained effect of spinal cord stimulation on pain and quality of life in painful diabetic peripheral neuropathy Editor—Painful diabetic peripheral neuropathy (PDPN) is a common complication of diabetes mellitus (DM) and may cause physical and emotional suffering with severe impact on quality of life (QoL).1 Pharmacological treatment often is only partially effective or unsuccessful due to unacceptable side-effects. Spinal cord stimulation (SCS) is considered a possible treatment modality. Recently, the short- and long-term
10.0
1.00 0.80
8.0
0.40 4.0
38
QoL
Pain
0.60 6.0
40 0.20
42 44
2.0
0.00 –0.20
0 Baseline
12 months 24 months
36 months
Baseline
12 months
24 months
36 months
Fig 1 Scores for daytime pain intensity and QoL during follow-up. Presented are the median (50th percentile) and the interquartile range (IQR) (25th and 75th percentile).
1030
Downloaded from http://bja.oxfordjournals.org/ at University of California Santa Barbara/Davidson Library on July 15, 2015
References
results of SCS in PDPN were reviewed,2 showing sufficient pain relief in 15 out of 24 patients (63%) after 1 yr.3 – 5 After 2.5–3 yr, the percentage of patients who experienced pain relief remained 63%, although the number of patients decreased from 24 to 19.3 6 In view of these findings, we studied the longterm effectiveness of SCS on pain and QoL in patients with PDPN. The short-term results of SCS were reported earlier in a prospective open-label cohort study.7 Besides the effect of SCS on pain, effect on patients’ QoL was investigated. Complications and adverse events were registered. The study protocol was approved by the local Medical Ethics Committee, and all patients gave written informed consent. Fifteen patients [eight male, mean age 59.9 yr (range 50 – 72)] with PDPN in the lower limbs met the eligibility criteria.7 A 2 week trial stimulation with an octapolar lead (Octadw lead, Medtronic, Minneapolis, MN, USA) was performed to evaluate sufficient pain relief before definitive SCS system implantation (Synergy Versitrelw, Medtronic) as described elsewhere.7 Eleven patients [seven male, mean age 60.9 yr (50 – 72)] received a definitive SCS system after positive trail stimulation. The primary outcome parameters were pain intensity, scored with a numeric rating scale, and patients’ global impression of change (PGIC) scale at 12, 24, and 36 months. Successful treatment was defined as ≥50% decrease in pain intensity at daytime and/or night-time, and/or peak pain and/or significant improvement of painful symptoms measured with the PGIC.7 Additionally, health-related QoL was assessed using the EuroQol-5 dimensions (EQ-5D) questionnaire.8 9 Four patients had mild neuropathy and seven had moderateto-severe neuropathy.10 The duration of DM was 18.3 (SD 20.6) yr, the mean duration of neuropathy and of painful symptoms was 11.0 (SD 16.0) and 5.3 (SD 3.4) yr, respectively. The group of 11 patients showed a significant pain reduction during daytime and night-time and peak pain at all time points compared with baseline, except for night-time pain after 24 months (Fig. 1). The majority of patients showed a significant
Correspondence
Acknowledgements The authors would like to acknowledge the patients who participated in the study. Furthermore, we would like to thank M.N. Janssen, MD, for performing SCS system implantation and the members, especially Dr E.A. Joosten, of the multidisciplinary steering committee for their scientific expertise. R. Slangen* W. A. Pluijms C. G. Faber C. D. Dirksen A. G. H. Kessels M. van Kleef Maastricht, The Netherlands * E-mail: [email protected]
Declaration of interest None declared.
Funding This work was supported by a grant from Medtronic for the employment of one researcher for 3 yr. Medtronic was not involved in the analysis and interpretation of the data. This study was guided by a multidisciplinary steering committee. 1 Doth AH, Hansson PT, Jensen MP, Taylor RS. The burden of neuropathic pain: a systematic review and meta-analysis of health utilities. Pain 2010; 149: 338– 44
2 Pluijms WA, Slangen R, Joosten EA, et al. Electrical spinal cord stimulation in painful diabetic polyneuropathy, a systematic review on treatment efficacy and safety. Eur J Pain 2011; 15: 783– 8 3 de Vos CC, Rajan V, Steenbergen W, van der Aa HE, Buschman HP. Effect and safety of spinal cord stimulation for treatment of chronic pain caused by diabetic neuropathy. J Diabetes Complications 2009; 23: 40 –5 4 Kumar K, Toth C, Nath RK. Spinal cord stimulation for chronic pain in peripheral neuropathy. Surg Neurol 1996; 46: 363–9 5 Tesfaye S, Watt J, Benbow SJ, Pang KA, Miles J, MacFarlane IA. Electrical spinal-cord stimulation for painful diabetic peripheral neuropathy. Lancet 1996; 348: 1698–701 6 Daousi C, Benbow SJ, MacFarlane IA. Electrical spinal cord stimulation in the long-term treatment of chronic painful diabetic neuropathy. Diabet Med 2005; 22: 393–8 7 Pluijms WA, Slangen R, Bakkers M, et al. Pain relief and quality-of-life improvement after spinal cord stimulation in painful diabetic polyneuropathy: a pilot study. Br J Anaesth 2012; 109: 623–9 8 Dolan P. Modeling valuations for EuroQol health states. Med Care 1997; 35: 1095– 108 9 EuroQol—a new facility for the measurement of health-related quality of life. The EuroQol Group. Health Policy 1990; 16: 199– 208 10 Feldman EL, Stevens MJ, Thomas PK, Brown MB, Canal N, Greene DA. A practical two-step quantitative clinical and electrophysiological assessment for the diagnosis and staging of diabetic neuropathy. Diabetes Care 1994; 17: 1281– 9 11 Luo N, Johnson JA, Shaw JW, Feeny D, Coons SJ. Self-reported health status of the general adult U.S. population as assessed by the EQ-5D and Health Utilities Index. Med Care 2005; 43: 1078– 86 12 Johnson JA, Pickard AS. Comparison of the EQ-5D and SF-12 health surveys in a general population survey in Alberta, Canada. Med Care 2000; 38: 115–21
doi:10.1093/bja/aet397
Early surgical reintervention for haemostasis after breast surgery using persistent sensory block of a paravertebral block Editor—The use of analgesic thoracic paravertebral block (PVB) for breast cancer surgery is well established. We report a case with a sensory block that persisted long enough for an emergency reintervention. The patient gave approval to publish her case. A 60-yr-old female patient was undergoing surgery on a breast carcinoma. An elective breast tumour resection with radioisotope-guided sentinel lymph node biopsy under general anaesthesia associated with analgesic PVB was planned. Her medical history had no bleeding reported. The blood tests did not find any preoperative thrombocytopenia or abnormal haemostasis (PT 100%, aPTT 30 s). The PVB was performed on the conscious patient in the left lateral decubitus position at the T3–4 thoracic space right level just before induction of general anaesthesia. After skin disinfection and the use of sterile gloves, an injection of 20 ml ropivacaine (7.5 mg ml21) (Ropivacaine Kabiw, Fresenius Kabi, Sevres, France) was given via a 22 G×80 mm needle (SonoTAP cannula, Laboratoire Gamida Pajunk, Geisingen, Germany). The needle was inserted
1031
Downloaded from http://bja.oxfordjournals.org/ at University of California Santa Barbara/Davidson Library on July 15, 2015
pain relief of ≥50% during daytime and/or night-time and/or peak pain during follow-up. After 12 months, 73% showed ≥50% pain relief, which is similar to results from earlier studies.3 – 5 Another long-term study3 reported a success rate at 24 months of 75%, compared with 55% in our study population. After 36 months, 64% of the patients in our study reported pain relief. PGIC for pain revealed improvement in pain in 73%, 27%, and 36% of the patients at 12, 24, and 36 months, respectively. Overall success rates of SCS on pain relief were 91% at 12 months, 55% at 24 months, and 64% at 36 months. An improvement in QoL was seen in 64% of the patients at 12 months, 55% at 24 months, and 64% at 36 months. The baseline values of the EQ-5D utility scores [median 0.35 (interquartile range: 0.06–0.68)] (Fig. 1) were lower than previously described in PDPN1 and lower compared with two general population-based samples in the USA with mean utility scores of 0.8711 and 0.91.12 In two patients, a new pulse generator was implanted during the follow-up period. Owing to loss of benefit of SCS in two other patients, the SCS system was removed 29 and 34 months after implantation, respectively. No serious adverse events, infections, or wound breakdown occurred during the study. In conclusion, a sustained effect of SCS on pain and QoL is noted in PDPN patients. This makes SCS an acceptable treatment modality for those patients who do not respond to conventional medical treatment.
BJA
Correspondence
within the UK,4 it is important to consider ibogaine toxicity in the differential diagnosis of the acutely unwell intoxicated patient and in patients presenting with a prolonged QT interval and cardiac rhythm disturbance.
Declaration of interest None declared. I. Asua* Oxford, UK * E-mail: [email protected]
1 Alper KR, Lotsof HS, Frenken GMN, et al. Treatment of acute opiod withdrawal with ibogaine. Am J Addict 1999; 8: 234– 42 2 Mash DC, Kovera CA, Pablo J, et al. Ibogaine: complex pharmacokinetics, concerns for safety and preliminary efficacy measures. Ann N Y Acad Sci 2000; 914: 394–401 3 Hoelen DWM, Spiering W, Valk GD. Long QT syndrome induced by the antiaddiction drug ibogaine. N Engl J Med 2009; 360: 308– 9 4 BBC News Magazine, April 2012. Available at http://www.bbc.co. uk/news/magazine-17666589
doi:10.1093/bja/aet396
Sustained effect of spinal cord stimulation on pain and quality of life in painful diabetic peripheral neuropathy Editor—Painful diabetic peripheral neuropathy (PDPN) is a common complication of diabetes mellitus (DM) and may cause physical and emotional suffering with severe impact on quality of life (QoL).1 Pharmacological treatment often is only partially effective or unsuccessful due to unacceptable side-effects. Spinal cord stimulation (SCS) is considered a possible treatment modality. Recently, the short- and long-term
10.0
1.00 0.80
8.0
0.40 4.0
38
QoL
Pain
0.60 6.0
40 0.20
42 44
2.0
0.00 –0.20
0 Baseline
12 months 24 months
36 months
Baseline
12 months
24 months
36 months
Fig 1 Scores for daytime pain intensity and QoL during follow-up. Presented are the median (50th percentile) and the interquartile range (IQR) (25th and 75th percentile).
1030
Downloaded from http://bja.oxfordjournals.org/ at University of California Santa Barbara/Davidson Library on July 15, 2015
References
results of SCS in PDPN were reviewed,2 showing sufficient pain relief in 15 out of 24 patients (63%) after 1 yr.3 – 5 After 2.5–3 yr, the percentage of patients who experienced pain relief remained 63%, although the number of patients decreased from 24 to 19.3 6 In view of these findings, we studied the longterm effectiveness of SCS on pain and QoL in patients with PDPN. The short-term results of SCS were reported earlier in a prospective open-label cohort study.7 Besides the effect of SCS on pain, effect on patients’ QoL was investigated. Complications and adverse events were registered. The study protocol was approved by the local Medical Ethics Committee, and all patients gave written informed consent. Fifteen patients [eight male, mean age 59.9 yr (range 50 – 72)] with PDPN in the lower limbs met the eligibility criteria.7 A 2 week trial stimulation with an octapolar lead (Octadw lead, Medtronic, Minneapolis, MN, USA) was performed to evaluate sufficient pain relief before definitive SCS system implantation (Synergy Versitrelw, Medtronic) as described elsewhere.7 Eleven patients [seven male, mean age 60.9 yr (50 – 72)] received a definitive SCS system after positive trail stimulation. The primary outcome parameters were pain intensity, scored with a numeric rating scale, and patients’ global impression of change (PGIC) scale at 12, 24, and 36 months. Successful treatment was defined as ≥50% decrease in pain intensity at daytime and/or night-time, and/or peak pain and/or significant improvement of painful symptoms measured with the PGIC.7 Additionally, health-related QoL was assessed using the EuroQol-5 dimensions (EQ-5D) questionnaire.8 9 Four patients had mild neuropathy and seven had moderateto-severe neuropathy.10 The duration of DM was 18.3 (SD 20.6) yr, the mean duration of neuropathy and of painful symptoms was 11.0 (SD 16.0) and 5.3 (SD 3.4) yr, respectively. The group of 11 patients showed a significant pain reduction during daytime and night-time and peak pain at all time points compared with baseline, except for night-time pain after 24 months (Fig. 1). The majority of patients showed a significant
Correspondence
Acknowledgements The authors would like to acknowledge the patients who participated in the study. Furthermore, we would like to thank M.N. Janssen, MD, for performing SCS system implantation and the members, especially Dr E.A. Joosten, of the multidisciplinary steering committee for their scientific expertise. R. Slangen* W. A. Pluijms C. G. Faber C. D. Dirksen A. G. H. Kessels M. van Kleef Maastricht, The Netherlands * E-mail: [email protected]
Declaration of interest None declared.
Funding This work was supported by a grant from Medtronic for the employment of one researcher for 3 yr. Medtronic was not involved in the analysis and interpretation of the data. This study was guided by a multidisciplinary steering committee. 1 Doth AH, Hansson PT, Jensen MP, Taylor RS. The burden of neuropathic pain: a systematic review and meta-analysis of health utilities. Pain 2010; 149: 338– 44
2 Pluijms WA, Slangen R, Joosten EA, et al. Electrical spinal cord stimulation in painful diabetic polyneuropathy, a systematic review on treatment efficacy and safety. Eur J Pain 2011; 15: 783– 8 3 de Vos CC, Rajan V, Steenbergen W, van der Aa HE, Buschman HP. Effect and safety of spinal cord stimulation for treatment of chronic pain caused by diabetic neuropathy. J Diabetes Complications 2009; 23: 40 –5 4 Kumar K, Toth C, Nath RK. Spinal cord stimulation for chronic pain in peripheral neuropathy. Surg Neurol 1996; 46: 363–9 5 Tesfaye S, Watt J, Benbow SJ, Pang KA, Miles J, MacFarlane IA. Electrical spinal-cord stimulation for painful diabetic peripheral neuropathy. Lancet 1996; 348: 1698–701 6 Daousi C, Benbow SJ, MacFarlane IA. Electrical spinal cord stimulation in the long-term treatment of chronic painful diabetic neuropathy. Diabet Med 2005; 22: 393–8 7 Pluijms WA, Slangen R, Bakkers M, et al. Pain relief and quality-of-life improvement after spinal cord stimulation in painful diabetic polyneuropathy: a pilot study. Br J Anaesth 2012; 109: 623–9 8 Dolan P. Modeling valuations for EuroQol health states. Med Care 1997; 35: 1095– 108 9 EuroQol—a new facility for the measurement of health-related quality of life. The EuroQol Group. Health Policy 1990; 16: 199– 208 10 Feldman EL, Stevens MJ, Thomas PK, Brown MB, Canal N, Greene DA. A practical two-step quantitative clinical and electrophysiological assessment for the diagnosis and staging of diabetic neuropathy. Diabetes Care 1994; 17: 1281– 9 11 Luo N, Johnson JA, Shaw JW, Feeny D, Coons SJ. Self-reported health status of the general adult U.S. population as assessed by the EQ-5D and Health Utilities Index. Med Care 2005; 43: 1078– 86 12 Johnson JA, Pickard AS. Comparison of the EQ-5D and SF-12 health surveys in a general population survey in Alberta, Canada. Med Care 2000; 38: 115–21
doi:10.1093/bja/aet397
Early surgical reintervention for haemostasis after breast surgery using persistent sensory block of a paravertebral block Editor—The use of analgesic thoracic paravertebral block (PVB) for breast cancer surgery is well established. We report a case with a sensory block that persisted long enough for an emergency reintervention. The patient gave approval to publish her case. A 60-yr-old female patient was undergoing surgery on a breast carcinoma. An elective breast tumour resection with radioisotope-guided sentinel lymph node biopsy under general anaesthesia associated with analgesic PVB was planned. Her medical history had no bleeding reported. The blood tests did not find any preoperative thrombocytopenia or abnormal haemostasis (PT 100%, aPTT 30 s). The PVB was performed on the conscious patient in the left lateral decubitus position at the T3–4 thoracic space right level just before induction of general anaesthesia. After skin disinfection and the use of sterile gloves, an injection of 20 ml ropivacaine (7.5 mg ml21) (Ropivacaine Kabiw, Fresenius Kabi, Sevres, France) was given via a 22 G×80 mm needle (SonoTAP cannula, Laboratoire Gamida Pajunk, Geisingen, Germany). The needle was inserted
1031
Downloaded from http://bja.oxfordjournals.org/ at University of California Santa Barbara/Davidson Library on July 15, 2015
pain relief of ≥50% during daytime and/or night-time and/or peak pain during follow-up. After 12 months, 73% showed ≥50% pain relief, which is similar to results from earlier studies.3 – 5 Another long-term study3 reported a success rate at 24 months of 75%, compared with 55% in our study population. After 36 months, 64% of the patients in our study reported pain relief. PGIC for pain revealed improvement in pain in 73%, 27%, and 36% of the patients at 12, 24, and 36 months, respectively. Overall success rates of SCS on pain relief were 91% at 12 months, 55% at 24 months, and 64% at 36 months. An improvement in QoL was seen in 64% of the patients at 12 months, 55% at 24 months, and 64% at 36 months. The baseline values of the EQ-5D utility scores [median 0.35 (interquartile range: 0.06–0.68)] (Fig. 1) were lower than previously described in PDPN1 and lower compared with two general population-based samples in the USA with mean utility scores of 0.8711 and 0.91.12 In two patients, a new pulse generator was implanted during the follow-up period. Owing to loss of benefit of SCS in two other patients, the SCS system was removed 29 and 34 months after implantation, respectively. No serious adverse events, infections, or wound breakdown occurred during the study. In conclusion, a sustained effect of SCS on pain and QoL is noted in PDPN patients. This makes SCS an acceptable treatment modality for those patients who do not respond to conventional medical treatment.
BJA
