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Prevention of Phantom Limb Pain After Transtibial Amputation

TerminatedNot applicableNCT01626755
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

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
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