Ketamine Clinical Trials
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.
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Organisation Name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Overal Status: Terminated
Start Date: August 2013
Last Update: October 27, 2017
Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Brief Summary: 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.Conditions
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.
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.
- Phantom Limb Pain
- Chronic Pain
Total execution time in seconds: 0.48191404342651