Reuben 2006.
Methods | Double‐blinded (patient and outcome assessor), placebo‐controlled, RCT Sequence generation randomized follow‐up: 12 months |
Participants | Participants : 80 adults, at a teaching hospital, Springfield, MA, USA Operation: lower limb amputation because of ischaemic necrosis, secondary to peripheral vascular disease 2 groups, size: 40/40 Age (group 1, 2): 68 years (SD ± 12 ), 65 years (SD ± 17) Men/women (group 1, 2): 23/17, 25/15 Comorbidities (group 1, 2): BKA:AKA ratio 29:11, 26:14 |
Interventions |
Group 1 (treatment): GA (fentanyl), intra‐op perineural injection of bupivacaine 10 mL 0.25% and clonidine 100 µg, post‐op morphine IV and paracetamol (acetaminophen)/oxycodone orally Group 2 (placebo): GA (fentanyl), intra‐op perineural injection of placebo, post‐op morphine IV and paracetamol/oxycodone orally Adjuvants: clonidine perineurally Immediate post‐op pain control: statistically meaningful reduction in analgesic consumption |
Outcomes | Dichotomous: phantom limb pain and stump pain at 12 months Continuous: not reported Secondary: not reported |
Notes | The sciatic nerve was infiltrated for AKA or the posterior tibial nerve for BKA. We could not make sense of some numbers reported on attrition. As reported 22 January 2009, SS Reuben was accused of publishing fraudulent data. Up to 22 papers have been or will be retracted by the journals in which they have been published (Retraction notice Anesthesia and Analgesia 20 February 2009 (Shafer 2009)). This article appears not to be among the retracted manuscripts. We placed it in the classification pending section on the advice of Cochrane Anaesthesia, Critical and Emergency Care. |