Evaluation of Anterior Quadratus Lumborum Block for Postoperative Analgesia in Hip Arthroscopy: A Double-Blinded Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Numerical Pain Rating System (NRS) Pain Scores
研究概览
简要总结
Hip arthroscopy is performed frequently and the postoperative course often involves moderate to severe pain. There remains no definitive perioperative pain regimen that has been proven to be effective and safe for this ambulatory procedure. Some institutions perform peripheral nerve blocks either preoperatively or postoperatively as a rescue block. All of these PNBs lead to quadriceps weakness which may impede earlier mobilization and physical therapy. While some case reports exist, there have not been any studies evaluating the QLB for hip arthroscopy patients. As previously mentioned, the technique is easy to perform, well-tolerated by patients, and avoids side effects such as hypotension, urinary retention, or the quadriceps weakness associated with lumbar plexus blockade.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for hip arthroscopy
- •Ability to follow study protocol
- •English Speaking
排除标准
- •Hepatic or renal insufficiency
- •Younger than 18 years old and older than 80
- •Allergy or intolerance to one of the study medications
- •Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
- •Chronic opioid use (daily opioids use for longer than 3 months)
- •Patients contraindicated to undergo a spinal anesthetic
- •Non English Speakers
研究组 & 干预措施
QLB Block + Standard of Care
Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.
Patients will receive a single shot anterior QLB (30cc 0.5% Bupivacaine with 2mg preservative free dexamethasone).
干预措施: Bupivacaine + dexamethasone (Drug)
QLB Block + Standard of Care
Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.
Patients will receive a single shot anterior QLB (30cc 0.5% Bupivacaine with 2mg preservative free dexamethasone).
干预措施: Ultrasound (Device)
结局指标
主要结局
Numerical Pain Rating System (NRS) Pain Scores
时间窗: 24 hours after Post Anesthesia Care Unite (PACU) arrival
Pain scores at rest and with movement will be through 24 hours after surgery. Score scale is from 0-10. 0 means no pain, 10 means worst pain. A lower score is a better outcome.
次要结局
- Urinary Retention(Up to Post Op Day 1)
- Number of Patients With Presence of IAFE (Intraabdominal Fluid Extravasation) Following Surgery(Immediately post-op in OR)
- Incidence of Hypotension(Up to Post Op Day 1)
- Opioid Use(After Surgery to Post Operative Day 1)
- Antiemetic Use(Up to Post Op Day 1)
- Patient Satisfaction With Post Op Pain Control(Up to Post Op Day 1)
- Change in Quadriceps Motor Strength on Surgical Side(Up to Post Op Day 1)
- Number of Participants With Hospital Admission(Up to Post Op Day 1)
- Number of Patients With Nausea/Vomiting(Up to Post Op Day 1)
- Patient Score on Quality of Recovery-40 (QoR40) Inventory.(Up to Post Op Day 1)