NCT00443404

Optimized Perioperative Analgesia Reduces the Prevalence and the Intensity of Phantom Pain in Lower Limb Amputation

Double Blind, Placebo Controlled Study for the Study of the Effectiveness of Perioperative Analgesia in Phantom and Stump Pain

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Patras · Academic / Other
• Sex: All
• Age: 18 Years – 82 Years
• Healthy volunteers: Not accepted

Summary

Severe pre-amputation pain is associated with phantom pain development, and phantom pain models assign major importance to central and peripheral nervous system changes related to pre-amputation pain. Several interventions have been evaluated for phantom pain prevention, including continuous brachial plexus blockade5, intravenous6 or epidural ketamine administration, postoperative perineural ketamine/clonidine infusion8 and oral gabapentin9, but their true effect remains unclear.

Detailed description

In a prospective, randomized, double-blind trial, 65 patients undergoing elective lower limb amputation were assigned to one of five analgesic regimens. Patients in groups 1-4 had lumbar epidural catheter placed 48 hours before amputation, and received epidural bupivacaine/fentanyl or saline infusion before and/or after amputation. Patients receiving epidural saline also had IV Fentanyl Patient-Control Analgesia, whereas patients receiving epidural analgesia also had IV saline. Group 5 (control) received IM meperidine and oral codeine/acetaminophen. VAS and McGill Pain Questionnaire (MPQ) scores (for ischemic, phantom and stump pain) were recorded starting 48 hours before, continuing until 48 hours after amputation, and at 4 days, 10 days, 1 and 6 months after amputation. Phantom and stump pain intensity and frequency were the main study endpoints.

Conditions

• Phantom Limb Pain

Interventions

Type	Name	Description
PROCEDURE	perioperative epidural catheter	Perioperative epidural catheter in groups 1-4. Pre- and postoperative epidural analgesia in group 1. Preoperative IV PCA Fentanyl and postoperative epidural analgesia in group 2. Perioperative IV PCA Fentanyl in groups 2,3. IM meperidine p.o. codeine/acetaminophen, IV acetaminophen and IV parecoxib in group 5 (control)

Timeline

• Start date: 2003-12-01
• Primary completion: 2008-05-01
• Completion: 2009-05-01
• First posted: 2007-03-06
• Last updated: 2011-11-07

Locations

1 site across 1 country: Greece