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Prevention of Phantom Limb Pain After Transtibial Amputation

NCT01626755 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-10-27

No results posted yet for this study

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.

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

Interventions

PROCEDURE

Sciatic name block

Ultrasound-guided sciatic nerve block.

Sponsors & Collaborators

  • European Society of Anaesthesiology

    collaborator OTHER

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • Markus Hollmann, MD PhD · Dept. of Anaesthesiology, Academic Medical Center / University of Amsterdam, The Netherlands

  • Philipp Lirk, MD PhD · Dept. of Anaesthesiology, Academic Medical Center / University of Amsterdam, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • United States
  • Austria
  • Belgium
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01626755 on ClinicalTrials.gov