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History of Changes for Study: NCT00443404
Perioperative Analgesia Reduces the Intensity of Phantom and Stump Pain in Lower Limb Amputation
Latest version (submitted November 4, 2011) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 5, 2007 None (earliest Version on record)
2 April 23, 2007 Study Status, Contacts/Locations and Eligibility
3 May 22, 2007 Contacts/Locations, Conditions, Study Description, Eligibility, Study Design and Study Status
4 May 23, 2007 Study Status and Study Design
5 November 1, 2007 Study Design, Arms and Interventions, Study Status and Outcome Measures
6 June 3, 2008 Study Status, Study Design and Sponsor/Collaborators
7 August 24, 2009 Recruitment Status, Study Status, Contacts/Locations, Study Design, Study Description and Eligibility
8 September 22, 2009 Study Status, Arms and Interventions, Conditions, Study Description, Contacts/Locations and Study Identification
9 January 12, 2010 Arms and Interventions, Sponsor/Collaborators, Study Status and Study Identification
10 November 4, 2011 Sponsor/Collaborators and Study Status
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Study NCT00443404
Submitted Date:  March 5, 2007 (v1)

Open or close this module Study Identification
Unique Protocol ID: phantom pain-UPatras
Brief Title: Perioperative Analgesia Reduces the Intensity of Phantom and Stump 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
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2007
Overall Status: Recruiting
Study Start: December 2003
Primary Completion:
Study Completion: December 2009
First Submitted: March 5, 2007
First Submitted that
Met QC Criteria:
March 5, 2007
First Posted: March 6, 2007 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 5, 2007
Last Update Posted: March 6, 2007 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of Patras
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: Phantom Pain occurs in 80% of lower extremity amputees, and can persist for years. Pre-amputation pain may be a risk factor for developing phantom pain. We tested the hypothesis that optimized perioperative analgesia decreases the frequency and intensity of phantom pain 6 months after amputation.For our study we use epidural and/or fentanyl PCA analgesia. We start analgesia 48 hours preoperative and continue for 48 hours postamputation.We use five groups of patients.
Detailed Description:

From December 2003 we conduct a prospective, randomized, double-blind trial. Patients are assigned to one of five analgesic regimens (Table 1). In groups 1-4 a lumbar epidural catheter is placed 48 hours before amputation, and patients receive an epidural infusion of either bupivacaine - fentanyl mixture or NS 0.9% before and/or after amputation, based on group assignment. Group 5 receive IM PRN meperidine and oral codeine/acetaminophen. VAS and McGill- PRI(R) 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.50 patients have been assigned to one of five analgesic regimens until today.

Table 1: Anesthesia and Analgesia Protocol by Group

GROUP-Preoperative Analgesia - Anesthesia - Postoperative Analgesia

  1. Epi Epi Epi
  2. PCA Epi Epi
  3. PCA Epi PCA
  4. PCA GA PCA
  5. IM Me, po AC GA IM Me, po AC

Epi=Epidural, GA=General Anesthesia, AC = Acetaminophen/Codeine tbs, Me = Meperidine. Epidural anesthesia: Bupivacaine 0.5% 10-15 ml + Fentanyl 100-200 mcg. Epidural analgesia: Bupivacaine 0.25% + Fentanyl 2 mcg/ml, 5-10 ml/h. PCA: IV Fentanyl 25-50 mcg, lockout 10 minutes. Doses are titrated to VAS<3

Open or close this module Conditions
Conditions: Lower Limp Amputation
Intensity of Phantom Limp Pain
Preemptive Analgesia Reduces Phantom Pain
Perioperative Analgesia Reduces Phantom Pain
Keywords: phantom
amputation
analgesia
pain
preemptive
perioperative
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms:
Masking: Double (masked roles unspecified)
Allocation: Randomized
Enrollment: 60
Open or close this module Arms and Interventions
Intervention Details:
Procedure: perioperative epidural catheter
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 82 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Written patient consent,
  • Age >18 years,
  • Age <82 years,
  • Good mental status

Exclusion Criteria:

  • Not written patient consent,
  • Age <18 years,
  • Age > 82 years,
  • Antiplatelet medication.
  • Not acceptable mental status
Open or close this module Contacts/Locations
Central Contact Person: Menelaos Karanikolas, MD, MPH
Telephone: 0030-2610999224
Email: karanikm@wustl.edu
Study Officials: Diamanto N. Aretha, MD
Principal Investigator
University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Departement of Anaesthesiology and Critical Care Medicine
Menelaos Karanikolas, MD, MPH,
Study Director
University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Departement of Anaesthesiology and Critical Care Medicine
Kriton S Filos, MD Professor
Study Chair
University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Departement of Anaesthesiology and Critical Care Medicine
Georgia Monantera, MD
Principal Investigator
University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Departement of Anaesthesiology and Critical Care Medicine
Ioannis Tsolakis, MD Professor
Study Director
University of Patras, School of medicine, University Hospital of Patras, Rion, 26500, Departement of Surgery
Locations: Greece, Rion
University Hospital of Patras, Departement of Anesthesiology and Critical Care Medicine
[Recruiting]
Patras, Rion, Greece, 26500
Contact:Principal Investigator: Menelaos Karanikolas, MD, MPH
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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