Ultrasound-Guided Lumbal Erector Spinae Plane Block on Postoperative Pain Management After Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- morphine consumption
研究概览
简要总结
The Erector Spinae Plane (ESP) block or spinal erector block was first described in September 2016 by a Canadian team. It's a block that was initially used for the treatment of chronic thoracic neuropathic pain. The ESP block is one of the inter-fascicular blocks and it's an easy-to-perform technique.In the literature, it has been reported that Lumbar ESPB provides effective analgesia after a hip surgery.
The purpose of this prospective randomized study was to compare the analgesic effects of the ultrasound-guided lumbar Erector Spinae Plane block on postoperative pain management versus the multimodal analgesia after total hip arthroplasty.
详细描述
Patients aged more than 18 years, ASA I-III scheduled for primary total hip arthroplasty with lateral approach and under general anesthesia Patients were randomly assigned, into 1 of 2 groups, namely, group ESPBL and group Placebo, using sealed envelopes
- For ESPBL group: Lumbar ESP block performed after anesthesia induction. A low-frequency ultrasound probe will be placed longitudinally 2-3 cm lateral to the L4 transverse process. Erector spinae muscle will be visualized on the hyperechoic transverse process. The block needle (100 mm, 22G) will be inserted cranio-caudal direction and following confirmation of the correct position of the needle, between the erectorspinae muscle and the transverse process,30 ml of local anesthetic (0.25% bupivacaine/0.2% ropivacaine) will be administered for the block.
- For Placebo group: patients had multimodal analgesia without lumbar ESP block Patients will be transferred to continuous care unit for 24 hours.
Post-operative analgesia will include:
- Paracetamol 1g IV every 8 hours for 1 day then oral paracetamol 1g every 8 hours for 4 weeks.
- Diclofenac sodium(50mg) 1 tablet x 2 per day for 5 days.
- PCA morphine (Patient Controlled Analgesia), as a rescue analgesia, programmed as: Bolus of 1mg/ refractory period of 10 min/ maximum dose set up at 10mg every 12h.
The primary outcome of the study is to compare postoperative opioids consumption in the first 24 postoperative hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •primary total hip arthroplasty with lateral approach and under general anesthesia .
排除标准
- •• Contraindication or refusal to regional anesthesia
- •Contraindication to non-steroidal anti-inflammatory (NSAID's)
- •Allergy to opioids
- •Allergy to paracetamol
- •Creatinine clearance < 30ml/min
- •Weight<50 kg or >100kg
- •Psychiatric disorders and difficulty of communication
- •Lower limb neurological deficit
- •Patients undergoing bilateral or revision total hip replacement
研究组 & 干预措施
hip arthroplasty with nerve block
Lumbar ESP block performed after anesthesia induction. A low-frequency ultrasound probe will be placed longitudinally 2-3 cm lateral to the L4 transverse process. Erector spinae muscle will be visualized on the hyperechoic transverse process. The block needle (100 mm, 22G) will be inserted cranio-caudal direction and following confirmation of the correct position of the needle, between the erectorspinae muscle and the transverse process,30 ml of local anesthetic (0.25% bupivacaine/0.2% ropivacaine) will be administered for the block
干预措施: Lumbal Erector Spinae Plane Block (Procedure)
hip arthroplasty with intravenous pain killers
intravenous pain killers
干预措施: intravenous pain killers (Procedure)
结局指标
主要结局
morphine consumption
时间窗: Day 1
total morphine dose
次要结局
- pain scores(Hour 2, Hour 4, Hour 6, Hour 12, Hour 18, Hour 24 and on Day 2 and Day 7.)
- intraoperative opioid consumption(end of surgery)
- pain on sitting position(Day 1)
- QR 9 score(Day 2)
- ROM(Day 1)
- pain during walk(Day 7)
研究者
Olfa kaabachi, MD
professor
University Tunis El Manar