Periarticular Nerve Group (PENG) Block for Postoperative Rehabilitation in Total Hip Arthroplasty: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 556
- 试验地点
- 1
- 主要终点
- postoperative Numeric Pain Rating Scale in motion
研究概览
简要总结
This randomized, double-blinded, placebo-controlled trial seeks to evaluate the efficacy of the pericapsular nerve group block on postoperative rehabilitation.
详细描述
The pericapsular nerve group, or PENG block, has been recently described and shows promise in providing analgesia to the hip joint. However, the effect of this block on postoperative rehabilitation is uncertain. This study compares a preoperative PENG block to a placebo before total hip arthroplasty under spinal anesthesia. The primary outcome measure is verticalization, walking distance, ability to go out of bed, active lifting of the limb, range of motion in the hip joint, bending range of motion, and abduction range of motion. The secondary measure is postoperative pain assessment during rehabilitation.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients > 18 years old undergoing unilateral total hip arthroplasty
排除标准
- •refusal to participate
- •Chronic opioid use
- •localized infection
研究组 & 干预措施
PENG with 20mL 0,5% Ropivacaine
Patients will receive a preoperative ultrasound-guided pericapsular nerve group block with 20 mL of 0.5% ropivacaine. Using appropriate sterile precautions and procedural sedation with up to 2 mg IV midazolam, an ultrasound (Mindrey TE9) equipped with either a linear 15-6 megahertz (MHz) or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the anterior inferior iliac spine, iliopubic eminence, and psoas muscle. After spinal anesthesia, a 22g 80 mm echogenic block needle (Stimuplex Ultra 360) is advanced lateral to medial, in the plane with the ultrasound beam, beneath the psoas tendon to the iliopubic eminence. 20 mL 0.5% ropivacaine is injected beneath the psoas tendon and above the iliopubic eminence in 5 mL increments with a periodic aspiration to prevent intravascular injection. The needle is withdrawn, and the needle entry site is wiped clean.
干预措施: Ropivacaine 0.5% Injectable Solution (Drug)
PENG block with 20mL 0,9% normal saline
Patients will receive a preoperative ultrasound-guided pericapsular nerve group block with 20 mL of 0.9% normal saline. Using appropriate sterile precautions and procedural sedation with up to 2 mg IV midazolam, an ultrasound (Mindrey TE9) equipped with either a linear 15-6 megahertz (MHz) or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the anterior inferior iliac spine, iliopubic eminence, and psoas muscle. After spinal anesthesia, a 22g 80 mm echogenic block needle (Stimuplex Ultra 360) is advanced lateral to medial, in the plane with the ultrasound beam, beneath the psoas tendon to the iliopubic eminence. 20 mL 0.9% normal saline is injected beneath the psoas tendon and above the iliopubic eminence in 5 mL increments with a periodic aspiration to prevent intravascular injection. The needle is withdrawn, and the needle entry site is wiped clean.
干预措施: 0,9% normal saline (Drug)
结局指标
主要结局
postoperative Numeric Pain Rating Scale in motion
时间窗: Day 4
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
次要结局
- Time to first opioid(96 hours postoperatively)
- total opioid consumption(96 hours postoperatively)
- Functional assessment: independent verticalization- by the balcony(First day after surgery)
- postoperative Numeric Pain Rating Scale et rest(Day 4)
- Functional assessment: getting out of bed without help(First day after surgery)
- Functional assessment: active elevation of the operated limb(First day after surgery)
- Functional assessment: walking by the balcony(First day after surgery)