Clinical trial NCT01626755: Prevention of Phantom Limb Pain After Transtibial Amputation
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Phantom Limb Pain
Chronic Pain
Prevention
Keywords: Phantom limb pain
Chronic pain
Amputation
Peripheral vascular disease
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: European Society of Anaesthesiology
First posted: 2012-06-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Point prevalence of chronic phantom limb pain
timeFrame: 12 months after amputation
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital, Dept. of Anesthesiology, Perioperative and Pain Medicine
state: Massachusetts
city: Klagenfurt
country: Austria
facility: General Hospital Klagenfurt
state: Carinthia
city: Innsbruck
country: Austria
facility: Innsbruck Medical University Hospital
state: Tirol
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg
state: Limburg
city: Amsterdam
country: Netherlands
facility: Academic Medical Center, University of Amsterdam
state: Noord-Holland
city: Hoorn
country: Netherlands
facility: Westfriesgasthuis
state: Noord-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Noord-Holland
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmus Ziekenhuis
city: Valencia
country: Spain
facility: Valencia University Hospital
Study officials:
affiliation: Dept. of Anaesthesiology, Academic Medical Center / University of Amsterdam, The Netherlands
name: Markus Hollmann, MD PhD
role: STUDY_CHAIR
affiliation: Dept. of Anaesthesiology, Academic Medical Center / University of Amsterdam, The Netherlands
name: Philipp Lirk, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.