Prevention of Phantom Limb Pain After Transtibial Amputation
Stopped early · Not applicable
Conditions studied: Phantom Limb Pain, Chronic Pain, Prevention
In brief
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.
Key facts
- Study ID
- NCT01626755
- Run by
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- People needed
- 12
- Starts
- 2013-08-01
- Expected to finish
- 2017-04-01
- Last updated by the study team
- 2017-10-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- patients undergoing elective transtibial amputation for peripheral vascular disease
- age over 18 years
- American Society of Anaesthesiology status II to IV
You may not qualify if…
- contraindication to peripheral regional anesthesia
- psychiatric disease
- pregnancy or breastfeeding status
- amputation for tumour surgery
- traumatic amputation
- inability to give written and informed consent.
Where it is running
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.