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Prevention of Phantom Limb Pain After Transtibial Amputation (PLATA)

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ClinicalTrials.gov Identifier: NCT01626755
Recruitment Status : Terminated (Lack of funding and recruitment.)
First Posted : June 25, 2012
Last Update Posted : October 27, 2017
Sponsor:
Collaborator:
European Society of Anaesthesiology
Information provided by (Responsible Party):
Philipp Lirk, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Tracking Information
First Submitted Date  ICMJE June 21, 2012
First Posted Date  ICMJE June 25, 2012
Last Update Posted Date October 27, 2017
Actual Study Start Date  ICMJE August 2013
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2012)
Point prevalence of chronic phantom limb pain [ Time Frame: 12 months after amputation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Phantom Limb Pain After Transtibial Amputation
Official Title  ICMJE 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.
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.

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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Phantom Limb Pain
  • Chronic Pain
  • Prevention
Intervention  ICMJE Procedure: Sciatic name block
Ultrasound-guided sciatic nerve block.
Study Arms  ICMJE
  • 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.

    Intervention: Procedure: Sciatic name 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.

    Intervention: Procedure: Sciatic name block
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 25, 2017)
12
Original Estimated Enrollment  ICMJE
 (submitted: June 22, 2012)
400
Actual Study Completion Date  ICMJE April 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Netherlands,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01626755
Other Study ID Numbers  ICMJE PLATA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Philipp Lirk, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Sponsor  ICMJE Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators  ICMJE European Society of Anaesthesiology
Investigators  ICMJE
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
PRS Account Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP