Prevention of Phantom Limb Pain After Transtibial Amputation

NCT01626755 | Terminated DMC

• 1 other identifier: PLATA
• Study Type: interventional
• Target: 12
• Locations: 5 countries
• Sites: 9

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.

Conditions

Phantom Limb Pain; Chronic Pain; Prevention

Keywords

Phantom limb pain; Chronic pain; Amputation; Peripheral vascular disease

Outcome Measures

Primary Outcomes (1)

• Point prevalence of chronic phantom limb pain

  12 months after amputation

Study Arms (2)

Nerve block

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

Sciatic name block PROCEDURE

Ultrasound-guided sciatic nerve block.

Control; Nerve block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing elective transtibial amputation for peripheral vascular disease
• age over 18 years
• American Society of Anaesthesiology status II to IV

You may not qualify if:

• contraindication to peripheral regional anesthesia
• psychiatric disease
• pregnancy or breastfeeding status
• amputation for tumour surgery
• traumatic amputation
• inability to give written and informed consent.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• European Society of Anaesthesiology: collaborator

Study Sites (9)

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

Boston, Massachusetts, 02115, United States

Location

General Hospital Klagenfurt

Klagenfurt, Carinthia, Austria

Location

Innsbruck Medical University Hospital

Innsbruck, Tyrol, 6020, Austria

Location

Ziekenhuis Oost Limburg

Genk, Limburg, Belgium

Location

Academic Medical Center, University of Amsterdam

Amsterdam, North Holland, 1105AZ, Netherlands

Location

Westfriesgasthuis

Hoorn, North Holland, Netherlands

Location

Erasmus Medical Center

Rotterdam, North Holland, Netherlands

Location

Canisius Wilhelmus Ziekenhuis

Nijmegen, Netherlands

Location

Valencia University Hospital

Valencia, Spain

Location

Related Publications (2)

• Ypsilantis E, Tang TY. Pre-emptive analgesia for chronic limb pain after amputation for peripheral vascular disease: a systematic review. Ann Vasc Surg. 2010 Nov;24(8):1139-46. doi: 10.1016/j.avsg.2010.03.026.

  PMID: 20800987 BACKGROUND

• Rathmell JP, Kehlet H. Do we have the tools to prevent phantom limb pain? Anesthesiology. 2011 May;114(5):1021-4. doi: 10.1097/ALN.0b013e31820fc80d. No abstract available.

  PMID: 21383618 BACKGROUND

MeSH Terms

Conditions

Phantom Limb; Chronic Pain; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Anesthesiologist

Study Record Dates

• First Submitted: June 21, 2012
• First Posted: June 25, 2012
• Study Start: August 1, 2013
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: October 27, 2017

Record last verified: 2017-10

Locations

US (1); AU (2); NL (4); BE (1); ES (1)