Erector Spinae vs Fascia Iliaca Block in Hip Arthroplasty Post-operative Analgesia With Erector Spinae Plane Block After Total Hip Replacement Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Post-operative pain level measured by the Visual Analog Scale
研究概览
简要总结
The thoracic erector spinae plane (ESP) block was first described by Forero et al in September 2016. In their article, the authors presented the possibility of using this block as an option for the control of thoracic neuropathic pain as well as post-operative thoracic pain. The ESP block is done by administering local anesthetic in the plane deep to the erector spinae muscle, which spreads through the costotransverse foramen to the dorsal and ventral roots of the spinal nerves.
Since then, there have been reports about the successful use of this block for bariatric surgery, ventral hernia repair, radical mastectomy, rib fractures, major abdominal surgery and hip replacement. However, there are no studies in the literature comparing the efficacy of the ESP block to other nerve blocks.
The purpose of this study is to compare the post-operative analgesic efficacy of the ESP block to the fascia iliaca (FI) block after total hip replacement (THR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Surgical plan for total hip replacement
- •Signing of consent form to participate in the study
排除标准
- •Patient refusal
- •BMI > 40 kg/m2
- •Surgical plan for revision of hip replacement
- •Patient unable to quantify pain level
- •Chronic kidney disease with a Glomerular Filtration Rate < 50ml/min
- •Previously medicated with opioids
- •Patient unable to perform the surgery with spinal block
- •Allergy to local anesthetics
- •Infection in the site of the Erector Spinae Plane or Fascia Iliaca block
- •Allergy or contraindication to the use of morphine
研究组 & 干预措施
Control-group
No peripheral nerve block
Single-shot erector spinae plane block
The patient is positioned in lateral decubitus. The anesthesiologist uses a linear high-frequency probe in a longitudinal direction laterally to the mid-sagittal plane at the level of L4 until the transverse process is identified and, more superficial, the erector spinae muscle. A 22G needle of 80mm is introduced in-plane craniocaudally towards the transverse process of L4 until its tip is in the plane deep to the erector spinae muscle. Single-shot block with 30ml of ropivacaine 0,5% + adrenaline 100mcg
干预措施: Single-shot erector spinae plane block (Procedure)
Single-shot fascia iliaca block
The patient is positioned in dorsal decubitus. The anesthesiologist uses a linear high-frequency probe in a transversal direction, below the crural arch so as to identify the femoral artery. Afterwards the probe is moved laterally to find the iliac muscle and its fascia. A 22G needle of 80mm is introduced in-plane latero-medially until its tip is below the fascia iliaca (between the muscle and its fascia). Single-shot block with 40ml of ropivacaine 0,2%.
干预措施: Single-shot fascia iliaca block (Procedure)
结局指标
主要结局
Post-operative pain level measured by the Visual Analog Scale
时间窗: At 24 hours post-operative
Measurement of patient's pain level using the Visual Analog Scale (with a score of 0-100, 0 being no pain and 100 maximum pain)
Post-operative pain level measured by morphine consumption using patient-controlled intravenous analgesia
时间窗: At 24 hours post-operative
Total amount (in mg) of morphine administered by a patient-controlled intravenous analgesia pump of morphine 1mg/ml with bolus of 1ml per patient request with a lockout time of 10 minutes
Post-operative pain level measured by the Visual Analog Scale
时间窗: At 6 hours post-operative
Measurement of patient's pain level using the Visual Analog Scale (with a score of 0-100, 0 being no pain and 100 maximum pain)
Post-operative pain level measured by the Visual Analog Scale
时间窗: At 12 hours post-operative
Measurement of patient's pain level using the Visual Analog Scale (with a score of 0-100, 0 being no pain and 100 maximum pain)
次要结局
- Sensory block assessed through a tactile stimulation test(At 24 hours post-operative)
- Muscle Strength grade(At 24 hours post-operative)
- Sensory block assessed through a temperature test(At 24 hours post-operative)
- Detection of side effects related to the anesthetic and analgesic technique namely pruritus, urinary retention, nausea and vomiting in each patient(At 24 hours post-operative)
- Muscle Strength grade(At 12 hours post-operative)
研究者
André Carrão
Principal Investigator
Hospital Beatriz Ângelo