Evaluating the Addition of Obturator Nerve Block to Adductor Canal Block for Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Morphine Equivalence Consumption
研究概览
简要总结
One common anesthetic that is performed for total knee replacement surgery is spinal anesthesia with an adductor canal regional block, which involves injecting numbing medication in the thigh region for pain control after surgery. The aim of this study is to determine whether the addition of another regional block called obturator nerve block, which involves injecting numbing medication in the upper thigh region, will improve pain control after surgery while not sacrificing mobility after surgery.
详细描述
There is currently no consensus on the optimal strategy that provides the most effective postoperative analgesia while preserving ambulation and limiting side effects such as nausea and vomiting. The clinical team's hypothesis is that the obturator nerve block in addition to adductor canal block can target both the anterior and posterior distribution of nerves to the knee to provide superior analgesia while not limiting ambulation. To test this hypothesis, the clinical team will compare the rate of IV opioid consumption in patients who receive a combination of adductor canal block and obturator nerve block at the surgical site versus patients who receive adductor canal block alone.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo total knee arthroplasty
- •Planned use of regional anesthesia for procedure
- •Willing and able to provide informed consent
排除标准
- •Patients on immunosuppressive therapy
- •Patients with history of diabetes
- •Patients with lower limb neuropathy
- •Patients with history of chronic opioid use for > 3 months, including but not limited to, fentanyl, morphine, oxycodone, methadone
- •Patients with known allergy or intolerance to any drug used in the study
- •Patients with history of alcohol or drug abuse
- •Patients with history of intolerance of nonsteroidal anti-inflammatory drugs
- •Patients with hepatic or renal insufficiency
- •ASA score of 4 or greater
研究组 & 干预措施
Investigational arm
Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine
干预措施: Obturator nerve regional block (Drug)
Investigational arm
Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine
干预措施: Adductor canal regional block (Drug)
Control arm
Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with saline
干预措施: Adductor canal regional block (Drug)
Control arm
Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with saline
干预措施: Saline (Drug)
结局指标
主要结局
Morphine Equivalence Consumption
时间窗: up to 24 hours after surgery
Total amount of opioids consumed
次要结局
- Pain Score(1, 6, 12, and 24 hours after surgery)
- Number of Participants With Nausea or Vomiting(up to 24 hours after surgery)
- Time to Ambulation(on postoperative day 1 after surgery)
- Time to Breakthrough Pain Medication(up to post operative day 2 after surgery)
- Analgesia Satisfaction Score(2 weeks after surgery)
研究者
Christina Jeng
Christina Jeng MD Assistant Professor
Icahn School of Medicine at Mount Sinai