Effect of a Lateral Nerve of the Thigh Block on Postoperative Pain After Total Hip Replacement Surgery: a Clinical Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- VAS-score 4 hours postoperative during movement
研究概览
简要总结
The purpose of this study was to evaluate the analgesic efficacy of the nervus cutaneous femoral lateralis (NCFL) blockade on postoperative pain after total hip replacement surgery. The NCFL-block is a pure sensory block. We hypothesized that the NCFL-block would reduced the postoperative pain without delaying mobilization.
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)
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
- •Primary total hip replacement
排除标准
- •general anaesthesia
- •Allergy to local anesthetics of the amide type
- •Revision surgery
- •Bilateral surgery
- •Chronic pain patient
- •Women in the fertile age
研究组 & 干预措施
Ropivacaine
8 ml of ropivacaine 7,5 mg/ml will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided.
干预措施: Ropivacaine (Drug)
Ropivacaine
8 ml of ropivacaine 7,5 mg/ml will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided.
干预措施: An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively (Device)
Placebo
8 ml of isotonic saline will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided
干预措施: Placebo (Drug)
Placebo
8 ml of isotonic saline will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided
干预措施: An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively (Device)
结局指标
主要结局
VAS-score 4 hours postoperative during movement
时间窗: 4 hours postoperative
VAS-score 4 hours postoperative during 30 degrees of flexion of the hip. VAS-score: 0-100 mm; 0: no pain, 100: worst imaginable pain.
次要结局
- Oxynorm consumption(0-24 hours postoperative)
- Mobilization(0-24 hours postoperatively)
- Length of stay(0-7 days postoperative)
- VAS-score 0-24 hours postoperative during movement(0-24 hours postoperatively)
- VAS-score 0-24 hours postoperative at rest(0-24 hours postoperatively)
- time to first oxynorm requirement(0-24 hours postoperatively)
研究者
Daniel Hägi-Pedersen
Consultant
Naestved Hospital