A Comparison of Analgesic Efficacy of Ultrasound-Guided Genicular Nerve Block Versus Saline Injection for Total Knee Replacement
Study Details
Study Description
Brief Summary
Do ultrasound-guided genicular nerve blocks with 0.5% bupivacaine provide improved knee analgesia for patients recovering from total knee replacement surgery compared to saline injection?
Hypotheses:
The investigators hypothesize that the combination of ultrasound-guided adductor canal block (ACB) and genicular nerve block will achieve lower opioid consumption and therefore lead to decreased systemic side effects and improved overall satisfaction compared to ultrasound-guided saline injection for patients undergoing minimally invasive elective total knee arthroplasty (TKA).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Group 1 Patient will receive genicular nerve block with bupivacaine |
Drug: bupivacaine
Group 1 will receive genicular nerve block using bupivacaine
|
Placebo Comparator: Group 2 Patient will receive normal saline as the nerve block |
Drug: saline
Group 2 will receive genicular nerve block using normal saline
|
Outcome Measures
Primary Outcome Measures
- Post-operative opioid consumption during the hospital stay [21 days after surgery]
Post-operative opioid consumption measured in morphine equivalents during the hospital stay.
Secondary Outcome Measures
- Pain scores in the knee at rest and during activity recorded every 6 hours up to discharge [21 days after surgery]
Pain scores in the knee at rest and during activity. This will be measured every 6 hours up to discharge with the visual analog scale where 0 equals no pain and 10 equals excruciating pain. Low pain scores are considered a better outcome than high pain scores.
- Overall global pain score recorded every 6 hours up to discharge [21 days after surgery]
Overall global pain score. This will be measured every 6 hours up to discharge with the visual analog scale where 0 equals no pain and 10 equals excruciating pain. Low pain scores are considered a better outcome than high pain scores.
- Overall pain burden for the first 36 hours [36 hours after surgery]
Pain burden is defined as the area under the visual analog scale for pain over the first 36 hours and will be calculated using the trapezoidal method. Time to report first pain and overall patient satisfaction between groups will be compared using the Kruskal-Wallis H test.
- Opioid related side effects [21 days after surgery]
- Time to physical therapy milestones [21 days after surgery]
active straight leg raise, time until patient first gets out of bed, ambulation about the hospital room with or without assistance, ambulating 100 feet and ability to climb stairs
- Length of hospitalization [21 days after surgery]
- Readmission to the hospital or emergency room visit for evaluation during study [1 year after surgery]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participants 40 to 85 years old who are presenting for minimally invasive total knee arthroplasty under spinal anesthesia and are candidates for peripheral nerve blocks.
-
Minimally invasive is defined as custom modified instrumentation, a quadriceps sparing arthrotomy that does not extend beyond 1cm proximal to the patella and surgical techniques that focus on soft tissue protection.
Exclusion Criteria:
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Patient refusal
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American Society of Anesthesiologists physical status classification of 4 or higher
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Pre-existing neuropathy in the femoral or sciatic distribution
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Coagulopathy
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Infection at the site
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Chronic opioid use (greater than 3 months)
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Pregnancy
-
Medical conditions limiting physical therapy participation
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Any other contra-indication to regional anesthesia
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Northwestern University | Chicago | Illinois | United States | 60611 |
Sponsors and Collaborators
- Northwestern University
Investigators
- Principal Investigator: Antoun M Nader, MD, Northwestern University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STU#:00204116