Back to results

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

Primary Purpose

Phantom Limb Pain

Status

Completed

Phase

Phase 2

Locations

Greece

Study Type

Interventional

Intervention

perioperative epidural catheter

About this trial

This is an interventional prevention trial for Phantom Limb Pain focused on measuring 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

Eligibility Criteria

18 Years - 82 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

perioperative epidural analgesia

Iv PCA Fentanyl preoperative, Epidural analgesia postoperative

perioperative IV PCA Fentanyl, epidural anesthesia

perioperative IV PCA Fentanyl general anesthesia

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

Outcomes

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00443404

First Posted

March 5, 2007

Last Updated

November 4, 2011

Sponsor

University of Patras

1. Study Identification

Unique Protocol Identification Number

NCT00443404

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Completed

Study Start Date

December 2003 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Patras

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Phantom Limb Pain

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Factorial Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

perioperative epidural analgesia

Arm Title

Arm Type

Active Comparator

Arm Description

Iv PCA Fentanyl preoperative, Epidural analgesia postoperative

Arm Title

Arm Type

Active Comparator

Arm Description

perioperative IV PCA Fentanyl, epidural anesthesia

Arm Title

Arm Type

Active Comparator

Arm Description

perioperative IV PCA Fentanyl general anesthesia

Arm Title

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

perioperative epidural catheter

Intervention Description

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)

Primary Outcome Measure Information:

Title

Time Frame

six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

82 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials: