Prevention of Phantom Limb Pain After Transtibial Amputation (PLATA)

October 25, 2017 updated by: Philipp Lirk, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Rationale:

Phantom limb pain following amputation is a major clinical 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.

Study population:

Patients undergoing elective transtibial amputation for peripheral vascular disease at one of the participating centres, ASA status II to IV.

Intervention:

Infusion of local anesthetic via sciatic nerve catheter placed under ultrasound guidance.

Main study parameter/endpoint:

Point prevalence of chronic phantom limb pain after 12 months.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

All patients, regardless of group allocation, will receive optimalized intravenous pain treatment. The aim of this study is to assess whether additional regional anesthesia (ultrasound-guided sciatic nerve block) can decrease the incidence of phantom limb pain. The working hypothesis is that patients undergoing intervention treatment (optimized intravenous therapy plus nerve block) are expected to feature a decreased incidence of phantom limb pain at 12 months, in addition to improved perioperative analgesia.

The administration of both optimalized intravenous pain treatment and peripheral nerve blockade is routine clinical practice for many procedures on the lower leg, including amputation. The risk of this intervention can be described as very low. In control patients, the sciatic catheter will be used for rescue pain treatment.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Carinthia
      • Klagenfurt, Carinthia, Austria
        • General Hospital Klagenfurt
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • Innsbruck Medical University Hospital
  • Belgium
    • Limburg
      • Genk, Limburg, Belgium
        • Ziekenhuis Oost Limburg
  • Netherlands
      • Nijmegen, Netherlands
        • Canisius Wilhelmus Ziekenhuis
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105AZ
        • Academic Medical Center, University of Amsterdam
      • Hoorn, Noord-Holland, Netherlands
        • Westfriesgasthuis
      • Rotterdam, Noord-Holland, Netherlands
        • Erasmus Medical Center
  • Spain
      • Valencia, Spain
        • Valencia University Hospital
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Massachusetts General Hospital, Dept. of Anesthesiology, Perioperative and Pain Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nerve block

Optimized intravenous pain treatment during surgery and for 7 days postoperatively.

Definition: strong opioid patient-controlled analgesia, non-opioids, ketamine intravenously.

Sciatic nerve block: infusion of local anesthetic.
Procedure: Sciatic name block
Ultrasound-guided sciatic nerve block.
Active Comparator: Control

Optimized intravenous pain treatment during surgery and for 7 days postoperatively.

Definition: strong opioid patient-controlled analgesia, non-opioids, ketamine intravenously.

Sciatic nerve block: saline infusion.
Procedure: Sciatic name block
Ultrasound-guided sciatic nerve block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Point prevalence of chronic phantom limb pain
Time Frame: 12 months after amputation
12 months after amputation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

European Society of Anaesthesiology

Investigators

  • Study Chair: Markus Hollmann, MD PhD, Dept. of Anaesthesiology, Academic Medical Center / University of Amsterdam, The Netherlands
  • Principal Investigator: Philipp Lirk, MD PhD, Dept. of Anaesthesiology, Academic Medical Center / University of Amsterdam, The Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2013

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

June 21, 2012

First Submitted That Met QC Criteria

June 22, 2012

First Posted (Estimate)

June 25, 2012

Study Record Updates

Last Update Posted (Actual)

October 27, 2017

Last Update Submitted That Met QC Criteria

October 25, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLATA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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