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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

Page last updated: August 23, 2015

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