Pre-emptive Sciatic Bloc to Prevent Lower Limb Phantom Pain
Primary Purpose
Phantom Limb Pain
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
sciatic nerve block
Sponsored by
About this trial
This is an interventional prevention trial for Phantom Limb Pain focused on measuring Pre-emptive analgesia, Peripheral nerve block (sciatic), phantom lomb pain
Eligibility Criteria
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)
Sites / Locations
- CHU
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
sciatic block
Arm Description
One arm, all patient studied received a block
Outcomes
Primary Outcome Measures
incidence of lower limb phantom pain
Secondary Outcome Measures
Full Information
NCT ID
NCT00528463
First Posted
September 10, 2007
Last Updated
February 1, 2010
Sponsor
Université de Sherbrooke
1. Study Identification
Unique Protocol Identification Number
NCT00528463
Brief Title
Pre-emptive Sciatic Bloc to Prevent Lower Limb Phantom Pain
Official Title
a Prospective Case Series of Pre-emptive Pre-amputation Sciatic Nerve Block to Prevent Lower Limb Phantom Pain
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Université de Sherbrooke
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phantom Limb Pain
Keywords
Pre-emptive analgesia, Peripheral nerve block (sciatic), phantom lomb pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sciatic block
Arm Type
Experimental
Arm Description
One arm, all patient studied received a block
Intervention Type
Procedure
Intervention Name(s)
sciatic nerve block
Intervention Description
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
Primary Outcome Measure Information:
Title
incidence of lower limb phantom pain
Time Frame
3 month post amputation
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ETIENNE DE MEDICIS, MD, MSC
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Pre-emptive Sciatic Bloc to Prevent Lower Limb Phantom Pain
We'll reach out to this number within 24 hrs