NCT03064165已完成4 期
Postoperative Analgesia After Elective Hip Surgery - Effect of Obturator
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Opioid dose 0-12 hour after total hip replacement
研究概览
简要总结
The study investigates the effect of an obturator nerve block on the postoperative pain and opioid consumption after total hip replacement.
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
- •Patients for primary hip replacement in spinal anesthesia
- •Age >= 18 years
- •American Society of Anesthesiologists physical status classification score I-III
- •Informed consent
排除标准
- •Lacking the ability to corporate
- •Lacking the ability to speak danish
- •Planned discharge on the same day of surgery
- •Neuropathy of the lower extremities
- •Contraindications for NonSteroidal Anti-Inflammatory Drugs (NSAID)
- •Contraindications for dexamethasone
- •Chronic opioid demanding pain
- •Pregnancy
- •Allergy towards one or both investigatory medicinal products
- •Active treatment with amiodarone
- •Active treatment with verapamil
- •Active treatment with corticosteroids
研究组 & 干预措施
Obturator nerve block
Experimental
Postoperative obturator nerve block with 15 mL bupivacain 5 mg/mL and epinephrine 5 µg/mL.
干预措施: Bupivacaine-epinephrine (Drug)
Obturator nerve block
Experimental
Postoperative obturator nerve block with 15 mL bupivacain 5 mg/mL and epinephrine 5 µg/mL.
干预措施: Obturator nerve block (Procedure)
Sham block
Placebo Comparator
Postoperative sham-block with normal saline.
干预措施: Sham block (Procedure)
Sham block
Placebo Comparator
Postoperative sham-block with normal saline.
干预措施: Sodium Chloride 9mg/mL (Drug)
结局指标
主要结局
Opioid dose 0-12 hour after total hip replacement
时间窗: 0-12 hour after completion of total hip replacement
Cumulated dose of opioid 0-12 hour after total hip replacement
次要结局
- Incidences of emesis 0-18 hours after total hip replacement.(0-18 hours after completion of total hip replacement)
- Cumulated dose of ondansetron 0-18 hours after total hip replacement(0-18 hours after completion of total hip replacement)
- Cumulated dose of droperidol 0-18 hours after total hip replacement(0-18 hours after completion of total hip replacement)
- Length of stay on post anesthesia care unit after completion of total hip replacement(24 hours after completion of total hip replacement)
- Length of stay on hospital after completion of total hip replacement(Up to 2 days)
- Ability to ambulate 5 hours after surgery(5 hours after completion of total hip replacement)
- Motor control with operated leg(5 hours after completion of total hip replacement)
- Cumulated dose of opioid 12-18 hours after total hip replacement.(12-18 hours after completion of total hip replacement)
- Pain at rest at time of examination (numeric rating scale)(1, 2, 5, 7 and 24 hours after completion of total hip replacement)
- Pain at passive 90-degree hip flexion (numeric rating scale)(1, 2, 5, 7 and 24 hours after completion of total hip replacement)
- Worst pain during ambulation on the day of surgery(5 hours after completion of total hip replacement)
- Time from completion of surgery to first dose of opioid(24 hours after completion of total hip replacement)
- Intensity of nausea on time of examination (numeric rating scale)(1, 2, 5, 7 and 24 hours after completion of total hip replacement)
- Duration of spinal anesthesia(0-4 hours after completion of total hip replacement)
- Self-reported sleep quality the first night after total hip replacement(24 hours after completion of total hip replacement)
研究者
Niels Dalsgaard Nielsen
MD, PhD-fellow
University of Aarhus
研究点 (1)
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