TerminatedN/AOther

Prevention of Phantom Limb Pain After Transtibial Amputation

Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

NCT ID
NCT01626755
Target Enrollment
12 participants
Start Date
2013-08
Est. Completion
2017-04

About This Study

Phantom limb pain following amputation is a major problem. Current evidence how to best prevent phantom limb pain is equivocal because previous trials have included small numbers of patients, and tested heterogeneous patient collectives. There is some evidence that optimized perioperative pain control is effective in preventing phantom limb pain, but the potential added role of regional anesthesia has not been defined. Objective: The Aim of this study is to test the hypothesis that sciatic nerve block decreases the point prevalence of phantom limb pain 12 months after transtibial amputation for peripheral vascular disease compared to optimized intravenous pain therapy. Study design: Randomized, prospective, double-blind (patient, physician, statistician) clinical trial. All patients will receive standard optimized intravenous anesthesia and analgesia (opiate patient-controlled analgesia (PCA), intravenous ketamine). Patients in the intervention group will receive additional infusion of local anesthetic via a sciatic nerve catheter placed under ultrasound guidance. Main outcome of this study: Point prevalence of chronic phantom limb pain after 12 months.

Conditions Studied

Phantom Limb PainChronic PainPrevention

Interventions

  • Sciatic name block

Eligibility

Age:18 Years - N/A
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

* patients undergoing elective transtibial amputation for peripheral vascular disease
* age over 18 years
* American Society of Anaesthesiology status II to IV

Exclusion Criteria:

* contraindication to peripheral regional anesthesia
* psychiatric disease
* pregnancy or breastfeeding status
* amputation for tumour surgery
* traumatic amputation
* inability to give written and informed consent.

Study Locations (9)

Massachusetts General Hospital, Dept. of Anesthesiology, Perioperative and Pain Medicine
Boston, Massachusetts, United States
General Hospital Klagenfurt
Klagenfurt, Carinthia, Austria
Innsbruck Medical University Hospital
Innsbruck, Tyrol, Austria
Ziekenhuis Oost Limburg
Genk, Limburg, Belgium
Academic Medical Center, University of Amsterdam
Amsterdam, North Holland, Netherlands
Westfriesgasthuis
Hoorn, North Holland, Netherlands
Erasmus Medical Center
Rotterdam, North Holland, Netherlands
Canisius Wilhelmus Ziekenhuis
Nijmegen, Netherlands
Valencia University Hospital
Valencia, Spain

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source

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