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

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ClinicalTrials.gov Identifier: NCT00443404
Recruitment Status : Completed
First Posted : March 6, 2007
Last Update Posted : November 6, 2011
Sponsor:
Information provided by:
University of Patras

Tracking Information
First Submitted Date  ICMJE March 5, 2007
First Posted Date  ICMJE March 6, 2007
Last Update Posted Date November 6, 2011
Study Start Date  ICMJE December 2003
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2007)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 5, 2007)
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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimized Perioperative Analgesia Reduces the Prevalence and the Intensity of Phantom Pain in Lower Limb Amputation
Official Title  ICMJE Double Blind, Placebo Controlled Study for the Study of the Effectiveness of Perioperative Analgesia in Phantom and Stump Pain
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Phantom Limb Pain
Intervention  ICMJE 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)
Study Arms  ICMJE
  • Active Comparator: 1
    perioperative epidural analgesia
    Intervention: Procedure: perioperative epidural catheter
  • Active Comparator: 2
    Iv PCA Fentanyl preoperative, Epidural analgesia postoperative
    Intervention: Procedure: perioperative epidural catheter
  • Active Comparator: 3
    perioperative IV PCA Fentanyl, epidural anesthesia
    Intervention: Procedure: perioperative epidural catheter
  • Active Comparator: 4
    perioperative IV PCA Fentanyl general anesthesia
    Intervention: Procedure: perioperative epidural catheter
  • 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
    Intervention: Procedure: perioperative epidural catheter
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 5, 2007)
60
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 82 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00443404
Other Study ID Numbers  ICMJE phantom pain-UPatras
There are no secondary Id
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Diamanto Aretha, University Hospital of Patras
Study Sponsor  ICMJE University of Patras
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University of Patras
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP