- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00443404
Optimized Perioperative Analgesia Reduces the Prevalence and the Intensity of Phantom Pain in Lower Limb Amputation
November 4, 2011 updated by: University of Patras
Double Blind, Placebo Controlled Study for the Study of the Effectiveness of Perioperative Analgesia in Phantom and Stump Pain
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Patras, Greece
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 82 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
perioperative epidural analgesia
|
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
|
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
|
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
|
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
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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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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six months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2003
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
March 5, 2007
First Submitted That Met QC Criteria
March 5, 2007
First Posted (Estimate)
March 6, 2007
Study Record Updates
Last Update Posted (Estimate)
November 6, 2011
Last Update Submitted That Met QC Criteria
November 4, 2011
Last Verified
September 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- phantom pain-UPatras
- There are no secondary Id
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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