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Sponsored by: |
University of Manitoba |
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Information provided by: | University of Manitoba |
ClinicalTrials.gov Identifier: | NCT00869037 |
The recovery from knee replacement surgery often involves a significant amount of pain. The best way to prevent/treat this pain is unknown. This study will compare two accepted methods of pain control in order to determine which is superior. The first method involves the injection of a solution containing multiple medications into the knee joint at the time of surgery. The second method involves the placement of a catheter adjacent to the femoral nerve which senses pain from the knee. This catheter is used to deliver local anesthetic which serves to block the transmission of pain signals from the nerve. The catheter will be left in place until 2 days after surgery. This method is combined with injection of local anesthetic in a particular area of the knee joint at the time of surgery. Patients will be followed until 2 days after surgery in order to determine which method is superior. We believe the second method will be deemed superior.
Condition | Intervention | Phase |
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Analgesia |
Drug: Periarticular Injection Drug: CFNB + Posterior Capsular Injection |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Analgesia After Total Knee Arthroplasty: Randomized Controlled Trial Comparing (a) Periarticular Multimodal Technique With (B) Continuous Femoral Nerve Block + Posterior Capsular Injection |
Estimated Enrollment: | 90 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Periarticluar Multimodal Technique: Active Comparator |
Drug: Periarticular Injection
A 20 ml bolus of saline will be given through the sham femoral nerve block catheter. Periarticular infiltration solution containing 400 mg Ropivicaine, 30 mg Ketorolac, 5 mg Epidural Grade Morphine, and 0.6 ml of 1:1000 Epinephrine will be made up to a volume of 100 ml with saline. Intra-op, 20 ml will be injected into the posterior capsule; 40 ml in the quadriceps mechanism, retinacular tissues, medial and lateral collateral ligaments; 40 ml in the skin and subcutaneous tissues. The sham catheter will be connected to a saline infusion running at 15 ml/hr until the morning of post-operative day 2. |
CFNB plus Posterior Capsular Injection: Active Comparator |
Drug: CFNB + Posterior Capsular Injection
A 20 ml bolus of 0.2% Ropivacaine will be given via a femoral nerve catheter. Periarticular infiltration will be performed intra-op. 20 ml of 1% Ropivacaine in the posterior capsule; 20 ml of normal saline in the quadriceps mechanism, retinacular tissues, medial and lateral collateral ligaments; 20 ml of normal saline for the skin and subcutaneous tissues. Postoperatively, the femoral catheter will be infused with 0.15% Ropivacaine running at 15 ml/hour until the morning of post-operative day 2
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sanjay Aragola, MD FRCA | 1-204-6617198 | saragola@sbgh.mb.ca |
Contact: Marshall S Tenenbein, MD | 1-204-996-7847 | marshalltenenbein@hotmail.com |
Canada, Manitoba | |
Concordia Hospital | |
Winnipeg, Manitoba, Canada, R2K 3S8 |
Principal Investigator: | Sanjay Aragola, MD, FRCA | University of Manitoba |
Principal Investigator: | Marshall S Tenenbein, MD | University of Manitoba |
Responsible Party: | Department of Anesthesia, Concordia General Hospital, University of Manitoba ( Sanjay Aragola ) |
Study ID Numbers: | B2008:123 |
Study First Received: | March 24, 2009 |
Last Updated: | March 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00869037 History of Changes |
Health Authority: | Canada: Health Canada |
Randomized controlled study Total knee arthroplasty Post operative pain |
Continuous Femoral Nerve Block Posterior Capsular injection Periarticular injection |
Morphine Ropivacaine Ketorolac Pain |
Epinephrine Ketorolac Tromethamine Pain, Postoperative |