Pericapsular Nerve Group Block for Analgesia After Hip Arthroplasty: a Randomized Double-Blind, Placebo-Controlled Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pain Score on first Mobilization
研究概览
简要总结
This study examine the effect of Pericapsular Nerve Group (PENG) Block on analgesia after elective hip arthroplasty. Half of participants will receive a PENG Block with local anesthetic, while the other half will receive a PENG Block with a placebo.
详细描述
Optimized analgesia is crucial for early mobilization after hip arthroplasty. Regional anesthesia, like fascia iliaca block or femoral nerve block, have limited indication because of motor blockade whereas local infiltrations analgesia have shown conflicting analgesic efficacy results in hip arthroplasty.
Pericapsular nerve group (PENG) block is a new regional anesthesia technique targeting specifically sensory nerve branches of the hip articulation. It has been originally described in hip fracture patients.
The aim of this study is to evaluate the efficacy of PENG block on analgesia after elective hip arthroplasty.
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)
盲法说明
Injected solutions will be prepared by an anesthetist not involved in the study protocol.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective total hip arthroplasty
- •General anesthesia
- •Enhanced Recovery Program
排除标准
- •American Society of Anesthesiologists (ASA) Score > 2
- •Drug allergy
- •Significant psychiatric disturbances
- •Preoperative opioid use
- •Contraindication to acetaminophen, celecoxib, methylprednisolone or tranexamic acid
- •Body Mass Index > 40 kg/m²
结局指标
主要结局
Pain Score on first Mobilization
时间窗: Postoperative time until midnight day 0
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[100-mm scale\]) will be used to evaluate pain on first mobilization at day 0 after surgery
次要结局
- Pain Score on mobilization Day 1 AM(Day 1 in the morning after surgery)
- Piritramid Consumption(Through the end of surgery until Post Anesthesia Care Unit discharge to the ward at day 0)
- Pain Score at Rest Day 2 AM(Day 2 in the morning after surgery)
- Pain Score on mobilization Day 2 AM(Day 2 in the morning after surgery)
- Pain Score on mobilization Day 2 PM(Day 2 in the afternoon after surgery)
- Morphine Consumption at Day 1(Postoperative time during Post Anesthesia Care Unit stay at day 0)
- Morphine Consumption at Day 2(Postoperative time until midnight day 2)
- First Mobilization Success(Postoperative time until midnight day 0)
- Maximum Pain Score in Post-Anaesthesia Care Unit(Through postoperative time during Post Anesthesia Care Unit stay at day 0)
- Pain Score at Rest 6h Postop(6 hours after surgery)
- Pain Score on mobilization Day 1 PM(Day 1 in the afternoon after surgery)
- Mean remifentanil Infusion Rate(Intraoperatively)
- Quadriceps weakness(Through postoperative time during Post Anesthesia Care Unit stay at day 0)
- Morphine Consumption at Day 0(Postoperative time until midnight day 0)
- Pain Score at Rest 2h Postop(2 hours after surgery)
- Pain Score at Rest 4h Postop(4 hours after surgery)
- Pain Score on mobilization 4h Postop(4 hours after surgery)
- Pain Score at Rest Day 1 AM(Day 1 in the morning after surgery)
- Pain Score on mobilization 2h Postop(2 hours after surgery)
- Pain Score on mobilization 6h Postop(6 hours after surgery)
- Pain Score at Rest Day 1 PM(Day 1 in the afternoon after surgery)
- Pain Score at Rest Day 2 PM(Day 2 in the afternoon after surgery)