Pericapsular Nerve Group (PENG) Block vs Intrathecal Morphine for Postoperative Analgesia in Patients Undergoing Total Hip Arthroplasty: a Randomized Non-inferiority Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Maximum pain with active hip flexion
研究概览
简要总结
To compare the impact of pericapsular nerve group (PENG) block to intrathecal morphine on postoperative analgesia, motor function and side effects in patients undergoing primary total hip arthroplasty under spinal anesthesia.
详细描述
The study aims to confirm the non-inferiority of PENG block vs intrathecal morphine in patients undergoing total hip arthroplasty under spinal anesthesia. Non-inferiority will be assessed regarding maximum pain on a numerical rating scale at rest and during active hip flexion and regarding cumulative morphine consumption during 48 postoperative hours. Impact on quadriceps muscle motor function and side effects including pruritus, nausea and vomiting and hypotension will also be assessed.
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
Randomization and study drug preparation by person(s) not involved in patient care, data gathering or outcome evaluation. Group allocation kept in sealed opaque envelope until all data gathered. Outcome assessor/statistician will be blinded as to which group received which intervention
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients with osteoarthritis of the hip scheduled for primary total hip arthroplasty under spinal anesthesia able to provide written informed consent
排除标准
- •patient unwilling / unable to provide informed consent
- •contraindications for any of the drugs and procedures included in the study protocol (allergies, local infection, coagulopathy)
- •high risk for perioperative morbidity/mortality (ASA Physical Status Classification IV)
- •preoperative use of strong opioid analgesia (due to hip pain or other acute/chronic pain condition)
- •pregnancy
- •substance abuse
- •Post Randomization Exclusion Criteria:
- •change of surgical plan
- •violation of study protocol
研究组 & 干预措施
PENG block
Patients scheduled for primary total hip arthroplasty after receiving spinal anesthesia will undergo pericapsular nerve group (PENG) block.
Postoperative multimodal analgesia with paracetamol, etoricoxib and oxycodone
干预措施: Pericapsular nerve group (PENG) block (Procedure)
PENG block
Patients scheduled for primary total hip arthroplasty after receiving spinal anesthesia will undergo pericapsular nerve group (PENG) block.
Postoperative multimodal analgesia with paracetamol, etoricoxib and oxycodone
干预措施: Spinal anesthesia (Procedure)
PENG block
Patients scheduled for primary total hip arthroplasty after receiving spinal anesthesia will undergo pericapsular nerve group (PENG) block.
Postoperative multimodal analgesia with paracetamol, etoricoxib and oxycodone
干预措施: Intrathecal placebo (Drug)
Intrathecal morphine
Patients scheduled for primary total hip arthroplasty will receive spinal anesthesia with local anesthetic and morphine administered intrathecally. After onset of spinal anesthesia a sham PENG block will be performed.
Postoperative multimodal analgesia with paracetamol, etoricoxib and oxycodone.
干预措施: Spinal anesthesia (Procedure)
Intrathecal morphine
Patients scheduled for primary total hip arthroplasty will receive spinal anesthesia with local anesthetic and morphine administered intrathecally. After onset of spinal anesthesia a sham PENG block will be performed.
Postoperative multimodal analgesia with paracetamol, etoricoxib and oxycodone.
干预措施: Intrathecal morphine (Drug)
Intrathecal morphine
Patients scheduled for primary total hip arthroplasty will receive spinal anesthesia with local anesthetic and morphine administered intrathecally. After onset of spinal anesthesia a sham PENG block will be performed.
Postoperative multimodal analgesia with paracetamol, etoricoxib and oxycodone.
干预措施: Sham PENG block (Procedure)
结局指标
主要结局
Maximum pain with active hip flexion
时间窗: 48 postoperative hours
maximum pain on a numerical rating scale with active 60 degrees hip flexion over first 48 post-operative hours Test treatment (PENG block) is to be considered non-inferior to reference treatment (intrathecal morphine) only if during final data analysis conditions of non-inferiority are met for all 3 co-primary outcomes
Maximum pain at rest
时间窗: 48 postoperative hours
maximum pain on a numerical rating scale at rest over first 48 post-operative hours Test treatment (PENG block) is to be considered non-inferior to reference treatment (intrathecal morphine) only if during final data analysis conditions of non-inferiority are met for all 3 co-primary outcomes
cumulative morphine equivalent dose over 48 post-operative hours
时间窗: 48 postoperative hours
cumulative opioid consumption including morphine rescue analgesia will be recorded during the first 48 postoperative hours Test treatment (PENG block) is to be considered non-inferior to reference treatment (intrathecal morphine) only if during final data analysis conditions of non-inferiority are met for all 3 co-primary outcomes
次要结局
- Opioid side effects(48 postoperative hours)
- Quadriceps muscle motor block(24 postoperative hours)
研究者
Kresimir Oremus, MD
Head of Division of Anesthesiology
Akromion Special Hospital for Orthopedic Surgery