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Clinical trialNCT01626755TerminatedInterventional

Prevention of Phantom Limb Pain After Transtibial Amputation

SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Enrollment12Chronic PainPhantom Limb PainPrevention
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

  • Markus Hollmann, MD PhD

    Dept. of Anaesthesiology, Academic Medical Center / University of Amsterdam, The Netherlands

    Study Chair
  • Philipp Lirk, MD PhD

    Dept. of Anaesthesiology, Academic Medical Center / University of Amsterdam, The Netherlands

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

9 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Austria
  • General Hospital Klagenfurt

    Klagenfurt, Carinthia, Austria

  • Innsbruck Medical University Hospital

    Innsbruck, Tyrol, Austria

Belgium
  • Ziekenhuis Oost Limburg

    Genk, Limburg, Belgium

Netherlands
  • 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

Spain
  • Valencia University Hospital

    Valencia, Spain

United States
  • Massachusetts General Hospital, Dept. of Anesthesiology, Perioperative and Pain Medicine

    Boston, Massachusetts, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Aug 2013
Primary completion
30 Apr 2017
Completion
30 Apr 2017
Last update posted
27 Oct 2017
Registered enrollment
12
Registry id
NCT01626755

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.