Prevention of Phantom Limb Pain After Transtibial Amputation
TerminatedNot applicableNCT01626755
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Prevention of Phantom Limb Pain After Transtibial Amputation (PLATA) - Randomized, Double-blind, Controlled, Multi-center Trial Comparing Optimized Intravenous Pain Control vs Optimized Intravenous Pain Control Plus Nerve Block.
- Conditions
- Phantom Limb Pain
- Chronic Pain
- Prevention
- Interventions
- Procedure: Sciatic name block
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Collaborators
- European Society of Anaesthesiology
- Start date
- 2013-08
- Primary completion
- 2017-04
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Austria, Belgium, Netherlands, Spain, United States
- Total sites listed
- 9
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01626755