The Analgesic Efficacy of the Ultrasound-Guided Femoral Articular Branch Block for Ambulatory Hip Arthroscopy: A Randomized-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Quality of Life scores
研究概览
简要总结
Hip arthroscopy surgery can be associated with significant pain. A regional anesthesia technique, the femoral articular branch block (FAB), has recently been proposed to collectively block terminal femoral and accessory obturator nerve branches to the hip joint with a single injection, theoretically blocking most of the innervation relevant to hip arthroscopy while sparing the main femoral nerve branches to the quadriceps muscles. The investigators aim to demonstrate the analgesic benefits of FAB. The investigators hypothesize that FAB will reduce opioid consumption and improve postoperative quality of recovery in patients having hip arthroscopy. This is a randomized, controlled, double-blind study and half the patients will be randomized to receive the femoral articular branch block and the other half of patients will be randomized to receive a placebo block. A comparison of pain will be made between both groups.
详细描述
Hip arthroscopy is a surgical technique that is gaining popularity for its diagnostic and therapeutic role in the management of adult hip pain. This procedure is frequently associated with severe post-operative pain despite the practice of injecting the hip joint with local anesthetics at the end of the procedure and the use of intraoperative opioids. The ideal analgesic technique that provides adequate pain relief following this procedure has not been established yet.
There is evidence to suggest that a femoral nerve block (FNB) may provide clinically meaningful analgesia. The investigators have examined the benefits of FNB both retrospectively and prospectively in hip arthroscopy patients at Women's College Hospital (WCH). Both of our studies suggested modest benefits of the FNB in terms of controlling post-operative pain and reducing opioid consumption. However the majority of patients continued to experience moderate to severe post-operative pain and required significant amounts of opioid analgesics in the Peri-Anesthesia Unit (PAU), despite receiving the FNB.
Another regional anesthesia technique, the femoral articular branch block (FAB) has recently been proposed to collectively block the terminal femoral and accessory obturator nerve branches to the hip joint with a single injection, theoretically blocking most of the innervation relevant to hip arthroscopy while sparing the main femoral nerve branches to the quadriceps muscle. The investigators aim to demonstrate the analgesic benefits of FAB.
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, Care Provider, Outcomes Assessor)
盲法说明
The anesthesiologist performing the nerve block will be aware of group allocation; but a separate anesthesiologist providing intra-operative care will remain blinded. The patient and the research staff collecting outcome data will remain blinded until all data are collected.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical classification system, ASA I-III patients
- •18 - 60 years of age
- •Body Mass Index (BMI) <35 kg/m2
排除标准
- •Pre-existing neurological deficits or peripheral neuropathy in the distribution of femoral, obturator, or lateral cutaneous nerves
- •Local infection
- •Contra-indication to regional anesthesia e.g. bleeding diathesis, coagulopathy
- •Chronic pain disorders
- •History of using over 30mg of oxycodone or equivalent per day
- •Contraindication to a component of multi-modal analgesia
- •Allergy to local anesthesia
- •History of significant psychiatric conditions that may affect patient assessment
- •Pregnancy
- •Inability to provide informed consent
- •Patient refusal of femoral articular branch block
- •Revision arthroscopy surgeries
结局指标
主要结局
Quality of Life scores
时间窗: 24 hours postoperatively
Quality of Recovery (QR15) scores at 24 hours will be the second primary outcome. QR15 is a measurement of quality of recovery after surgery and anesthesia that has been psychometrically tested and validated. Reporting of outcome measures on a scale of 0 to 10 (0=None of the time and 10=All of the time). There are a total of 40 items/questions.
Analgesic Consumption
时间窗: 24 hours postoperatively
Postoperative cumulative oral morphine equivalent consumption during the first 24 hours will be the first primary outcome
次要结局
- Presence of Block-related complications(Up until one month following nerve block)
- Analgesic Consumption(Up to 48 hours following surgery)
- Incidence of opioid-related side effects(Up until one month following nerve block)
- Pain Assessment (VAS)(Up to 48 hours post-operatively and at 7-day mark)
- Patient Satisfaction with Analgesic Technique(One month after surgery)
- Turn over time(after surgery up to discharge, assessed up to 24 hours)
- Demographic Data(Day 1 - first 24 hours)