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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
Sponsored by
University of Patras
About
Eligibility
Locations
Arms
Outcomes
Full info

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

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

4

5

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

First Posted
March 5, 2007
Last Updated
November 4, 2011
Sponsor
University of Patras
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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
1
Arm Type
Active Comparator
Arm Description
perioperative epidural analgesia
Arm Title
2
Arm Type
Active Comparator
Arm Description
Iv PCA Fentanyl preoperative, Epidural analgesia postoperative
Arm Title
3
Arm Type
Active Comparator
Arm Description
perioperative IV PCA Fentanyl, epidural anesthesia
Arm Title
4
Arm Type
Active Comparator
Arm Description
perioperative IV PCA Fentanyl general anesthesia
Arm Title
5
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
82 Years
Accepts Healthy Volunteers
No
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:
First Name & Middle Initial & Last Name & Degree
Diamanto N. Aretha, MD
Organizational Affiliation
University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Menelaos Karanikolas, MD, MPH
Organizational Affiliation
University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kriton S Filos, MD Professor
Organizational Affiliation
University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Georgia Monantera, MD
Organizational Affiliation
University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ioannis Tsolakis, MD Professor
Organizational Affiliation
University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Surgery
Official's Role
Study Director
Facility Information:
City
Patras
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
21368651
Citation
Karanikolas M, Aretha D, Tsolakis I, Monantera G, Kiekkas P, Papadoulas S, Swarm RA, Filos KS. Optimized perioperative analgesia reduces chronic phantom limb pain intensity, prevalence, and frequency: a prospective, randomized, clinical trial. Anesthesiology. 2011 May;114(5):1144-54. doi: 10.1097/ALN.0b013e31820fc7d2.
Results Reference
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Optimized Perioperative Analgesia Reduces the Prevalence and the Intensity of Phantom Pain in Lower Limb Amputation

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