Prevention of Phantom Limb Pain After Transtibial Amputation
NCT ID: NCT01626755
Last Updated: 2017-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
12 participants
INTERVENTIONAL
2013-08-31
2017-04-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Sciatic name block
Ultrasound-guided sciatic nerve block.
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.
Sciatic name block
Ultrasound-guided sciatic nerve block.
Interventions
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Sciatic name block
Ultrasound-guided sciatic nerve block.
Eligibility Criteria
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Inclusion Criteria
* age over 18 years
* American Society of Anaesthesiology status II to IV
Exclusion Criteria
* psychiatric disease
* pregnancy or breastfeeding status
* amputation for tumour surgery
* traumatic amputation
* inability to give written and informed consent.
18 Years
ALL
No
Sponsors
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European Society of Anaesthesiology
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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Philipp Lirk
Attending Anesthesiologist
Principal Investigators
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Markus Hollmann, MD PhD
Role: STUDY_CHAIR
Dept. of Anaesthesiology, Academic Medical Center / University of Amsterdam, The Netherlands
Philipp Lirk, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Anaesthesiology, Academic Medical Center / University of Amsterdam, The Netherlands
Locations
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Massachusetts General Hospital, Dept. of Anesthesiology, Perioperative and Pain Medicine
Boston, Massachusetts, United States
General Hospital Klagenfurt
Klagenfurt, Carinthia, Austria
Innsbruck Medical University Hospital
Innsbruck, Tyrol, Austria
Ziekenhuis Oost Limburg
Genk, Limburg, Belgium
Academic Medical Center, University of Amsterdam
Amsterdam, North Holland, Netherlands
Westfriesgasthuis
Hoorn, North Holland, Netherlands
Erasmus Medical Center
Rotterdam, North Holland, Netherlands
Canisius Wilhelmus Ziekenhuis
Nijmegen, , Netherlands
Valencia University Hospital
Valencia, , Spain
Countries
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References
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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.
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.
Other Identifiers
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PLATA
Identifier Type: -
Identifier Source: org_study_id