Comparison Between Femoral Nerve Block and Adductor Canal Block for Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Pain Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Ropivacaine 0.5% (Drug)
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.
干预措施: Percocet 7.5/325 (Drug)
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.
干预措施: Naprosyn 500 mg (Drug)
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.
干预措施: Ropivacaine 0.5% (Drug)
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.
干预措施: Percocet 7.5/325 (Drug)
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.
干预措施: Naprosyn 500 mg (Drug)
结局指标
主要结局
Pain Score
时间窗: 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.
次要结局
- 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)