The Analgesic Efficacy of Pericapsular Nerve Group (PENG) Block in Patients Undergoing Primary Total Hip Arthoplasty: a Prospective, Double-blinded, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Rate of postoperative opioid administration
研究概览
简要总结
The aim of this study is to investigate the analgesic efficacy of the pericapsular nerve group (PENG) block during the implantation of hip endoprostheses. The study is designed as a prospective randomized double-blind study and the study participants were randomized into 2 arms and either 20 ml ropivacaine 0.5% (verum group) or 20 ml physiological saline solution (placebo group) will be applied.
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
- Double (Participant, Investigator)
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
- •planned cementless hip TEP operation for primary coxarthrosis via minimally invasive anterolateral approach using the identical implant system (Taperloc stem, Plamafit cup)
- •Patient capable of giving consent
- •Informed consent has been obtained
- •age > 18 years
排除标准
- •Refusal to participate in the study
- •Regular use of opioids
- •Known chronic pain symptoms
- •Infections in the area of the puncture site
- •Presence of a contraindication to ropivacaine
- •Presence of a contraindication to metamizole
- •Presence of a contraindication to postoperative analgesia with diclofenac
- •Secondary forms of osteoarthritis with deformities (i.e. high-grade dysplasia, secondary conditions after trauma, secondary conditions after childtrauma, secondary conditions after childhood hip joint diseases
- •Spinopelvic dysbalance, spinal canal stenosis
- •Previous operations on the hip/pelvis
研究组 & 干预措施
Verum Group
20 ml ropivacaine 0.5%
干预措施: Ropivacaine (Drug)
Placebo Group
20 ml physiological saline
干预措施: Physiological saline (Other)
结局指标
主要结局
Rate of postoperative opioid administration
时间窗: 60 minutes after arrival in the recovery room
The primary objective is to investigate the influence of the PENG block on the need for postoperative ntravenously opioid administration within the first hour in the recovery room.
次要结局
- Quantity of total opioid consumption(until the evening of the second postoperative day)
- Intensity of postoperative pain(until the evening of the second postoperative day)
- Intensity of postoperative nausea and vomiting(until the evening of the second postoperative day)
- Postoperative recovery(until the evening of the second postoperative day)
研究者
Prof. Dr. Rainer Meierhernich
Principal Investigator
Diakonie-Klinikum Stuttgart