Comparison Between Femoral Nerve Block and Adductor Canal Block for Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Ropivacaine 0.5%
- Conditions
- Anterior Cruciate Ligament Reconstruction
- Sponsor
- Emory University
- Enrollment
- 115
- Locations
- 1
- Primary Endpoint
- Pain Score
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The objective of this study is to compare the pain control benefit of two different types of nerve blocks in patients undergoing anterior cruciate ligament (ACL) reconstruction.
Detailed Description
This trial is a prospective, randomized, surgeon-blinded, two-armed trial to investigate the safety and efficacy of femoral nerve blocks versus adductor canal blocks for participants undergoing outpatient anterior cruciate ligament (ACL) reconstruction surgery. The objective of this study is to compare the pain control benefit of two different types of nerve blocks. Ropivacaine, which is FDA-approved for use in both femoral nerve blocks as well as adductor canal blocks, will be utilized. The study will be comparing the efficacy between FDA approved treatments.
Investigators
John Xerogeanes
Professor
Emory University
Eligibility Criteria
Inclusion Criteria
- •Patients undergoing scheduled anterior cruciate ligament (ACL) surgery at the Emory Orthopaedic and Spine Center
- •Patients willing and able to provide written informed consent
- •Parents willing and able to provide written informed consent for minors
Exclusion Criteria
- •Patients who are pregnant or lactating
- •Patients with liver dysfunction or renal failure
- •Patients with a known allergy to ropivacaine
- •Patients with a local infection
- •Patients who take chronic pain medications
- •Patients with an opioid tolerance
- •Patients with known coagulopathy or bleeding risk.
- •Patients who are getting neuraxial anesthesia for surgery
Arms & Interventions
Femoral Nerve Block
Subjects undergoing anterior cruciate ligament (ACL) surgery will be randomized to receive 20 mL of ropivacaine 0.5% in the femoral nerve. Subjects will also receive standard of care Percocet 7.5/325 and naprosyn following surgery.
Intervention: Ropivacaine 0.5%
Femoral Nerve Block
Subjects undergoing anterior cruciate ligament (ACL) surgery will be randomized to receive 20 mL of ropivacaine 0.5% in the femoral nerve. Subjects will also receive standard of care Percocet 7.5/325 and naprosyn following surgery.
Intervention: Percocet 7.5/325
Femoral Nerve Block
Subjects undergoing anterior cruciate ligament (ACL) surgery will be randomized to receive 20 mL of ropivacaine 0.5% in the femoral nerve. Subjects will also receive standard of care Percocet 7.5/325 and naprosyn following surgery.
Intervention: Naprosyn 500 mg
Adductor Canal Block
Subjects undergoing anterior cruciate ligament surgery will be randomized to receive 20 mL of ropivacaine 0.5% in the adductor canal. Subjects will also receive standard of care Percocet 7.5/325 and naprosyn following surgery.
Intervention: Ropivacaine 0.5%
Adductor Canal Block
Subjects undergoing anterior cruciate ligament surgery will be randomized to receive 20 mL of ropivacaine 0.5% in the adductor canal. Subjects will also receive standard of care Percocet 7.5/325 and naprosyn following surgery.
Intervention: Percocet 7.5/325
Adductor Canal Block
Subjects undergoing anterior cruciate ligament surgery will be randomized to receive 20 mL of ropivacaine 0.5% in the adductor canal. Subjects will also receive standard of care Percocet 7.5/325 and naprosyn following surgery.
Intervention: Naprosyn 500 mg
Outcomes
Primary Outcomes
Pain Score
Time Frame: Post-surgery (day of surgery to 6 days post-surgery)
Pain scores range from 0 (no pain at all) to 10 (worst imaginable pain). Pain level was reported at the time of discharge from the surgery recovery room, the evening of the day of surgery, and then three times per day for six days post-surgery. During the six days after surgery, the morning assessment asked about typical knee pain levels overnight, the afternoon assessment asked about knee pain levels since the morning entry, and the evening assessment asked about knee pain levels since the afternoon entry.
Secondary Outcomes
- Patient-Reported Vomiting(Post-Surgery (up to 6 days))
- Number of Percocet Tablets Consumed(Post surgery, Day 0 to Day 6)
- Patient-Reported Nausea(Post-Surgery (up to 6 days))
- Patient-Reported Itching(Post-Surgery (up to 6 days))
- Total Hours of Sleep(First Postoperative Night (up to 12 hours))
- Patient-Reported Constipation(Post-Surgery (up to 6 days))
- Patient-Reported Sedation(Post-Surgery (up to 6 days))
- Time to Straight Less Raise(Post-Surgery (up to 6 days))
- Percent of Patients Rating Their Satisfaction as "Excellent" or "Good"(2 Weeks Post-Surgery)