Prevention of Phantom Limb Pain After Transtibial Amputation (PLATA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor:
Collaborator:
European Society of Anaesthesiology
Information provided by (Responsible Party):
Philipp Lirk, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01626755
First received: June 21, 2012
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Phantom Limb Pain
Chronic Pain
Prevention
Procedure: Sciatic name block

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • Point prevalence of chronic phantom limb pain [ Time Frame: 12 months after amputation ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: August 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626755

Contacts
Contact: Philipp Lirk, MD +31(20)566 ext 4032 p.lirk@amc.uva.nl
Contact: ESA Research Committee +32(2)7433290 research@esahq.org

Locations
Netherlands
Academic Medical Center, University of Amsterdam Recruiting
Amsterdam, Noord-Holland, Netherlands, 1105AZ
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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 Dept. of Anaesthesiology, Academic Medical Center / University of Amsterdam, The Netherlands
  More Information

Publications:
Responsible Party: Philipp Lirk, Attending Anesthesiologist, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01626755     History of Changes
Other Study ID Numbers: PLATA
Study First Received: June 21, 2012
Last Updated: September 12, 2013
Health Authority: Netherlands: Central Commission for Clinical Research (CCMO)

Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Phantom limb pain
Chronic pain
Amputation
Peripheral vascular disease

Additional relevant MeSH terms:
Phantom Limb
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Perceptual Disorders
Neurobehavioral Manifestations
Pain, Postoperative
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014