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

Overview

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.

Full Title of Study: “Double Blind, Placebo Controlled Study for the Study of the Effectiveness of Perioperative Analgesia in Phantom and Stump Pain”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2008

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.

Interventions

  • 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)

Arms, Groups and Cohorts

  • Active Comparator: 1
    • perioperative epidural analgesia
  • Active Comparator: 2
    • Iv PCA Fentanyl preoperative, Epidural analgesia postoperative
  • Active Comparator: 3
    • perioperative IV PCA Fentanyl, epidural anesthesia
  • Active Comparator: 4
    • perioperative IV PCA Fentanyl general anesthesia
  • Placebo Comparator: 5
    • IV PCA with saline 0.9% and sc saline 0.9%in the L3-L4 area. IM meperidine, po codeine/acetaminophen, IV acetaminophen and IV parecoxib

Clinical Trial Outcome Measures

Primary Measures

  • VAS and McGill PRI(R)2 scores for phantom and stump pain are recorded 48 and 24 hours before, and 4 and 10 days, 1 and 6 months after amputation. Phantom and stump pain intensity are the endpoints of the study.
    • Time Frame: six months

Participating in This Clinical Trial

Inclusion Criteria

  • Age >18, Visual Analog. Scale (VAS) pain score >70mm which was frequent or continuous one week before scheduled major (above or below knee) amputation, and patient consent. Exclusion Criteria:

  • No written patient consent – Age < 18 years – Age > 82 years – Antiplatelet medication – Mental status not acceptable Exclusion criteria were age >85 – Emergency amputation – Ipsilateral re-amputation – Foot or toe amputation – Inability to complete a detailed pain questionnaire – History of chronic pain or substance abuse – Active psychiatric disease requiring treatment – Any contraindication to epidural catheter placement (anticoagulation, anti-platelet medications, previous lumbar spine surgery).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 82 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Patras
  • Provider of Information About this Clinical Study
    • Diamanto Aretha, University Hospital of Patras
  • Overall Official(s)
    • Diamanto N. Aretha, MD, Principal Investigator, University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine
    • Menelaos Karanikolas, MD, MPH, Study Director, University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine
    • Kriton S Filos, MD Professor, Study Chair, University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine
    • Georgia Monantera, MD, Principal Investigator, University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine
    • Ioannis Tsolakis, MD Professor, Study Director, University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Surgery

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