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

Sponsor

University of Patras (Other)

Overall Status

Completed

CT.gov ID

NCT00443404

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Phantom Limb Pain	Procedure: perioperative epidural catheter	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Triple (Participant, 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

Study Start Date :

Dec 1, 2003

Actual Primary Completion Date :

May 1, 2008

Actual Study Completion Date :

May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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)

Outcome Measures

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. [six months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 82 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1		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