A Comparison of Sartorius Vs. Quadriceps Evoked Motor Response for Femoral Nerve to Prevent Secondary Catheter Failure
Recruitment status was Not yet recruiting
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Purpose
Objective: Continuous nerve block (freezing the nerve) is needed for knee replacement surgery to reduce pain, increase rehabilitation and discharge patients home fast. A lot of time, money and hospital resources are invested in inserting these catheters. The aim of this study is to compare two end points used for insertion of continuous femoral nerve block and to see which one results in fewer failures on the surgical ward.
Methodology: Patients having total knee replacement surgery will be recruited in this study. Patients will be randomized into two groups. The continuous femoral nerve block catheter will be inserted using ultrasound and nerve stimulation with two different end points (certain muscle contraction).
Patients will be followed on day 1 and 2 after surgery to observe which catheter fails, how much pain the patient suffers and how much painkiller the patients used.
| Condition | Intervention | Phase |
|---|---|---|
|
Arthroplasty, Replacement, Knee |
Other: Stimulation of quariceps muscle |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | A Comparison of Sartorius Vs. Quadriceps Evoked Motor Response for Femoral Nerve to Prevent Secondary Catheter Failure |
- the number of secondary catheter failures [ Time Frame: 12 months ] [ Designated as safety issue: No ]to prevent the occurance of failed femoral nerve catheter on postoperative day 1
- total morphine consumption [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: quadriceps
quadriceps muscular contraction
|
Other: Stimulation of quariceps muscle
stimulation of quadriceps muscle through the stimulating catheter
Other Names:
|
|
Active Comparator: sartorius
stimulation of sartorius muscle through femoral nerve
|
Other: Stimulation of quariceps muscle
stimulation of quadriceps muscle through the stimulating catheter
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients having total knee arthroplasty AsA 1-3
Exclusion Criteria:
- patients with a history of significant medical or psychiatric problems, BMI > 40, allergy to local anesthetic drugs, prior surgery in the inguinal region, neurological disease with sensory or motor deficit, and diabetic neuropathy.
Contacts and Locations| Contact: IMAD AWAD, MBChB | 416 480 4864 | imad.awad@sunnybrook.ca |
| Contact: colin MCCARTNEY, FRCPC |
| Canada, Ontario | |
| The Holland orthopedic and arthritic centre | Not yet recruiting |
| TOronto, Ontario, Canada | |
| Contact: imad awad | |
| Principal Investigator: | imad Awad, FFARCSI | Sunnybrook Hospital |
More Information
No publications provided
| Responsible Party: | Dr. Imad Awad, Sunnybrook Health Sciences Centre |
| ClinicalTrials.gov Identifier: | NCT01313546 History of Changes |
| Other Study ID Numbers: | Sunnybrook_Women's |
| Study First Received: | March 10, 2011 |
| Last Updated: | March 10, 2011 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Sunnybrook Health Sciences Centre:
|
Femoral nerve block total knee arthroplasty |
ClinicalTrials.gov processed this record on May 16, 2013