Optimized Perioperative Analgesia Reduces the Prevalence and the Intensity of Phantom Pain in Lower Limb Amputation
Information source: University of Patras
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Phantom Limb Pain
Intervention: perioperative epidural catheter (Procedure)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: University of Patras Official(s) and/or principal investigator(s): Diamanto N. Aretha, MD, Principal Investigator, Affiliation: University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine Menelaos Karanikolas, MD, MPH, Study Director, Affiliation: University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine Kriton S Filos, MD Professor, Study Chair, Affiliation: University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine Georgia Monantera, MD, Principal Investigator, Affiliation: University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine Ioannis Tsolakis, MD Professor, Study Director, Affiliation: University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Surgery
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.
Clinical Details
Official title: Double Blind, Placebo Controlled Study for the Study of the Effectiveness of Perioperative Analgesia in Phantom and Stump Pain
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: 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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 82 Years.
Gender(s): Both.
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).
Locations and Contacts
Patras, Greece
Additional Information
Starting date: December 2003
Last updated: November 4, 2011
|