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

This study has been completed.
Sponsor:
Information provided by:
University of Patras
ClinicalTrials.gov Identifier:
NCT00443404
First received: March 5, 2007
Last updated: November 4, 2011
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Phantom Limb Pain
Procedure: perioperative epidural catheter
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Double Blind, Placebo Controlled Study for the Study of the Effectiveness of Perioperative Analgesia in Phantom and Stump Pain

Resource links provided by NLM:


Further study details as provided by University of Patras:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: December 2003
Study Completion Date: May 2009
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
perioperative epidural analgesia
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)
Active Comparator: 2
Iv PCA Fentanyl preoperative, Epidural analgesia postoperative
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)
Active Comparator: 3
perioperative IV PCA Fentanyl, epidural anesthesia
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)
Active Comparator: 4
perioperative IV PCA Fentanyl general anesthesia
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)
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
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 82 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443404

Locations
Greece
Patras, Greece
Sponsors and Collaborators
University of Patras
Investigators
Principal Investigator: Diamanto N. Aretha, MD University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine
Study Director: Menelaos Karanikolas, MD, MPH University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine
Study Chair: Kriton S Filos, MD Professor University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine
Principal Investigator: Georgia Monantera, MD University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine
Study Director: Ioannis Tsolakis, MD Professor University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Surgery
  More Information

No publications provided by University of Patras

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Diamanto Aretha, University Hospital of Patras
ClinicalTrials.gov Identifier: NCT00443404     History of Changes
Other Study ID Numbers: phantom pain-UPatras, There are no secondary Id
Study First Received: March 5, 2007
Last Updated: November 4, 2011
Health Authority: Greece: Ethics Committee

Keywords provided by University of Patras:
phantom
amputation
analgesia
pain
preemptive
perioperative
lower limb amputation
intensity of phantom limb pain
preemptive analgesia reduces phantom pain
perioperative analgesia reduces phantom pain
Severe Phantom Limb Pain (VAS>70 mm)
resistant to medical treatment one week before amputation

Additional relevant MeSH terms:
Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Acetaminophen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014