- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00528463
Pre-emptive Sciatic Bloc to Prevent Lower Limb Phantom Pain
February 1, 2010 updated by: Université de Sherbrooke
a Prospective Case Series of Pre-emptive Pre-amputation Sciatic Nerve Block to Prevent Lower Limb Phantom Pain
Phantom limb pain is a complication of amputation.
Although pre-empitve epidural analgesia was once thought to prevent such a com plication, recent studies did not demonstrate this.
Peripheral blocks are more powerful then epidurals, and can even influence somatotropic representation in the brain.
This a prospective case series in which the investigators hope to show a decrease, against historical control, of the incidence of post-operative amputation lower limb phantom pain.
The investigators established the block at least 24 hours pre-operative and continue it for at least 2 days.
Patient are followed daily for the 1st 3 days and then up to 3 month for the incidence of phantom limb pain.
The investigators hope to recruit 30 patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Quebec
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Sherbrooke, Quebec, Canada, J1H 5N4
- CHU
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient scheduled for lower limb amputation
Exclusion Criteria:
- Inability to consent
- Contraindication to peripheral nerve block
- Inability to perform the block
- Inadequate time frame (less than 24 hours prior to surgery)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: sciatic block
One arm, all patient studied received a block
|
Sciatic nerve block, Labatt approach, with a stimuplex needle and catheter.
Once localized, a bolus of 20 mL ropivacaine 1,0% is given through the catheter and is followed by a perfusion of ropivacaine 0,2% 6-10 mL/hre for at least 24 hours pre-op and 48 hours post-op
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
incidence of lower limb phantom pain
Time Frame: 3 month post amputation
|
3 month post amputation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: ETIENNE DE MEDICIS, MD, MSC, Université de Sherbrooke
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (Actual)
September 1, 2007
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
September 10, 2007
First Submitted That Met QC Criteria
September 11, 2007
First Posted (Estimate)
September 12, 2007
Study Record Updates
Last Update Posted (Estimate)
February 2, 2010
Last Update Submitted That Met QC Criteria
February 1, 2010
Last Verified
September 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- edm1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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