The Analgesic Efficacy of the Ultrasound-Guided Femoral Articular Branch Block for Ambulatory Hip Arthroplasty: A Randomized-Controlled Trial Secondary IDs:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 95
- 主要终点
- Analgesic Consumption
研究概览
简要总结
Hip arthroplasty 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 arthroplasty. 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 arthroplasty 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. These patients usually receive a spinal anesthetic as well. The ideal analgesic technique that provides adequate pain relief following this procedure has not been established yet.
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
- Quadruple (Participant, Care Provider, Investigator, 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-III patients
- •Ages 18-60yrs
- •BMI ≤ 35 kg/m2
排除标准
- •Preexisting 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 use of over 30mg oxycodone or equivalent per day
- •Contraindication to a component of multi-modal analgesia
- •Allergy to local anesthetics
- •History of significant psychiatric conditions that may affect patient assessment
- •Pregnancy
- •Inability to provide informed consent
- •Patient refusal of FAB
- •Revision arthroscopy surgeries
结局指标
主要结局
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
Quality of Life scores
时间窗: 24 hours postoperatively
Quality of Recovery (QR15) scores at 24 hours will be the second primary outcome.
次要结局
- Analgesic Consumption(Up to 48 hours following surgery)
- Pain Assessment (VAS)(Up to 48 hours post-operatively)
- Block Success(4 hours after nerve block has been administered)
- Incidence of block-related complications(Up until one month following nerve block)
- Patient Satisfaction with Analgesic Technique(One month after surgery)
- Demographic Data(Day 1 - first 24 hours)
- Incidence of opioid-related side effects(Up until one month following nerve block)