Comparison of Ultrasound-guided PENG Block and Supra-inguinal Fascia Iliaca Compartment Block for Postoperative Opioids Consumption and Early Motor Recovery After Total Hip Arthroplasty: a Randomized Controlled Non-inferiority Clinical Trial.
试验速览
- 阶段
- 4 期
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- NRS 6 hours
研究概览
简要总结
To compare the impact of pericapsular nerve group block (PENG) versus the supra-inguinal fascia-iliaca compartment block (SFICB) in postoperative analgesia, opioid sparing and enhanced recovery after surgery of total hip arthroplasty by poster-lateral approach.
详细描述
ASA physical status 1, 2 and 3 patients scheduled to undergo elective total hip arthroplasty by poster-lateral (Moore) surgical approach with spinal anesthesia.
The investigators want to confirm the non-inferiority of the SFICB compared to the PENG block on postoperative first 6 hours after surgery NRS pain score and 48 hours opioids consumption, and the difference between these in terms of early recovery and motor impact on two first day after surgery. The principal investigator perform these regional anesthesia techniques with ultrasound guided injections.
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, Outcomes Assessor)
盲法说明
Non-inferiority controlled RCT with two groups simple-blinded
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults patients scheduled to undergo elective primary total hip arthroplasty by posterior surgical approach with spinal anesthesia
排除标准
- •Patient refusal
- •Allergy to administrated drugs or local infection
- •Pregnancy
- •History of chronic pain
- •Drugs addiction
- •Mental ou neurological diseases
- •Kidney or liver serious diseases
研究组 & 干预措施
PENG block
Patients scheduled for total hip arthroplasty with spinal anesthesia receive before intra-thecal injection, ultrasound-guided PENG block. Patients in PENG group receive multimodal postoperative analgesia techniques coupled with morphine PCA pump.
干预措施: Pericapsular nerves group (PENG) block (Procedure)
PENG block
Patients scheduled for total hip arthroplasty with spinal anesthesia receive before intra-thecal injection, ultrasound-guided PENG block. Patients in PENG group receive multimodal postoperative analgesia techniques coupled with morphine PCA pump.
干预措施: Ropivacaine 0,75% in PENG block (Drug)
SFICB block
Patients scheduled for total hip arthroplasty with spinal anesthesia receive before intra-thecal injection, ultrasound-guided supra-inguinal fascia iliaca compartment block. Patients in SFICB group receive multimodal postoperative analgesia techniques coupled with morphine PCA pump.
干预措施: Supra-inguinal fascia-iliaca compartment block (Procedure)
SFICB block
Patients scheduled for total hip arthroplasty with spinal anesthesia receive before intra-thecal injection, ultrasound-guided supra-inguinal fascia iliaca compartment block. Patients in SFICB group receive multimodal postoperative analgesia techniques coupled with morphine PCA pump.
干预措施: Ropivacaine 0,375% in SFICB block (Drug)
结局指标
主要结局
NRS 6 hours
时间窗: 6 hours after surgery
The primary endpoint of the study will be the between-group comparisons in postoperative NRS pain scores on 0 to 10 scale.
次要结局
- QoR-15(72 hours after surgery)
- 2 minutes walk test(24 hours after surgery)
- 6 minutes walk test(48 jours after surgery)
- Opioids secondaires side effects(48 hours after surgery)
- Opioid sparing(48 hours after intervention)
- DN4(72 hours after surgery)
- IPO(72 hours after surgery)
研究者
Jean François Brichant
Head of Anesthesiology Departement
University of Liege