Impact of Supra-inguinal Fascia Iliaca Compartment Block on Postoperative Opioid Consumption in Total Hip Arthroplasty Interventions by Posterior Approach
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Opioid sparing
研究概览
简要总结
Find the impact of supra-inguinal fascia iliaca compartment block on postoperative pain management after total hip arthroplasty by posterior surgical approach
详细描述
ASA physical status 1, 2 and 3 patients scheduled to undergo elective surgery of total hip arthroplasty under spinal anesthesia.
The investigators would like to study the impact of supra-inguinal fascia iliaca block on postoperative pain management after total hip arthroplasty by posterior surgical approach. The principal investigator perform this block with ultrasound technique. The investigators also want to observe if this loco-regional new approach to fascia iliaca block could have influence on opioid side effects, postoperative nausea and vomiting, length of hospitalisation and first mobilisation side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
Two group simple-blinded RCT: placebo vs fascia iliaca group. Surgeon and patient are blinded of the patient's group. Investigator and loco-regional technique provider know the patient's group.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults patients scheduled to undergo elective surgery of total hip arthroplasty by posterior surgical aboard
排除标准
- •Patient refusal
- •Allergy to used medications or local infection.
- •Pregnancy
- •Obesity with body mass index > 35
- •History of chronic pain or fibromyalgia
- •Drug (opioids) addiction
- •Treatment with corticosteroids for more than 6 months
- •Severe kidney or liver diseases
- •Mental disorders or serious neurological diseases
研究组 & 干预措施
Placebo
Placebo group: patients have multimodal analgesia without fascia-iliaca compartment block
干预措施: Multimodal analgesia and PCA morphine pump (Drug)
Fascia iliaca block
Patients in this arm have multimodal analgesia with supra-inguinal fascia iliaca compartment block before surgery
干预措施: Supra-inguinal fascia iliaca compartment block (Procedure)
Fascia iliaca block
Patients in this arm have multimodal analgesia with supra-inguinal fascia iliaca compartment block before surgery
干预措施: Multimodal analgesia and PCA morphine pump (Drug)
结局指标
主要结局
Opioid sparing
时间窗: 48 hours after the intervention
Difference in cumulated morphine consumption in the first 48 hours after surgery
次要结局
- Opioid secondaries effects(48 hours after the intervention)
- Pain management satisfaction: questionnaire(48 hours after the intervention)
研究者
Jean François Brichant
Head of Anesthesiology Department
University of Liege