Defining the Best Approach to Block the Pain After Knee Surgery
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|ClinicalTrials.gov Identifier: NCT00294073|
Recruitment Status : Unknown
Verified August 2005 by McGill University Health Center.
Recruitment status was: Recruiting
First Posted : February 20, 2006
Last Update Posted : June 19, 2007
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative||Procedure: Fascia Iliaca Block Procedure: Femoral Block (with stimulating catheter) Procedure: Femoral Block (without stimulating catheter)||Phase 3|
60 patients being treated for ACL repair or knee arthroplasties under regional anesthesia will be randomized to three groups: Fascia Iliaca Block (FIB), Femoral Block (FB) with stimulating catheter or FB without stimulating catheter. A catheter will be placed according to each technique, before the surgery. A bolus of local anesthetic will be given pre-surgery and at the end of the operation, in all groups. A continuous infusion will be started for 48 hours. All patients receive a standard analgesia cocktail and rescue medication.
Pain and level of activity, as well as side effects, will be evaluated.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Defining the Best Approach to Block the Pain After Knee Surgery|
|Study Start Date :||July 2005|
- pain relief; measured by VAS at rest and on activity [ Time Frame: before surgery, before discharge from PACU and on evenings of days 1, 2, 7, 60, 90 ]
- pain relief; measured by WOMAC [ Time Frame: before surgery and at days 7, 60, 90 ]
- pain relief; evaluated from standard datasheet [ Time Frame: over 48-hour period ]
- knee range of bending [ Time Frame: measured before surgery, and at days 7, 60, 90 ]
- thigh circumference 20 cm above the knee [ Time Frame: measured before surgery and at days 7, 60, 90 ]
- neurological exam of femorocutaneous, femoral and obturator nerves [ Time Frame: evaluated once spinal anesthesia has worn off, post-surgery, before anesthesia ]
- level of activity; measured using questionnaire [ Time Frame: at 7-10 days and at 2 and 3 months ]
- need for rescue analgesia [ Time Frame: in recovery room and at home ]
- need for second bolus or crossing over between groups
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00294073
|Contact: Juan F Asenjo, MD||514-934-1934 ext firstname.lastname@example.org|
|Montreal General Hospital||Recruiting|
|Montreal, Quebec, Canada, H3G 1A4|
|Principal Investigator: Juan F Asenjo, MD|
|Principal Investigator:||Juan F Asenjo, MD||Montreal General Hospital|