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

NCT00443404 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-11-07

No results posted yet for this study

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.

Conditions

  • Phantom Limb Pain

Interventions

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)

Sponsors & Collaborators

  • University of Patras

    lead OTHER

Principal Investigators

  • Diamanto N. Aretha, MD · University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine

  • Menelaos Karanikolas, MD, MPH · University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine

  • Kriton S Filos, MD Professor · University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine

  • Georgia Monantera, MD · University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine

  • Ioannis Tsolakis, MD Professor · University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Surgery

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
82 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2008-05-31
Completion
2009-05-31

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00443404 on ClinicalTrials.gov