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临床试验/NCT05003544
NCT05003544已完成不适用

Comparıson Of PENG Block wıth Intra-articular And Quadratus Lumborum Block İn Primary Total Hip Arthroplasty: : Randomized Controlled Double Blinded Trial Trial

Karaman Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2021年8月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
89
试验地点
2
主要终点
Numerical Rating Scale (NRS) scores

研究概览

简要总结

90 patients ASA I-III, undergoing Total hip arthroplasty (THA) under spinal anesthesia, will be randomly assigned into one of three groups, namely group A (n=30), where an PENG block, group B (N:30) where an inra-articuler, and group C (n=30) where Quadratus lumborum block will be performed preoperatively. All patients will receive a standardized postoperative analgesia regimen. NRS scores will be evaluated in static and dynamic conditions during the first 48 hours postoperatively.

详细描述

Total hip arthroplasty (THA) is the second most common joint replacement surgery, partly due to the aging population. The primary aim of this study is to compare the analgesic efficacy of Pericapsular nerve group (PENG) block with intra-articular and Quadrotus lumborum block (QLB). Regional anesthesia (RA), such as the recently described pericapsular nerve group (PENG) block, may provide additional analgesic benefit in this situation. Pericapsular nerve group (PENG) block is a new regional anesthesia technique to provide analgesia after hip fractures and hip arthroplasty. The aim of this single-center, double-blind, randomized controlled trial is to confirm the efficacy of PENG block for postoperative recovery after primary THA.

Routine multimodal analgesia will be used for postoperative analgesia

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Physical status according to American Society of Anesthesiologists (ASA ) I-III

排除标准

  • Previous operation on the same hip
  • Hepatic or renal insufficiency
  • Younger than 18 years old and older than 85
  • Patients undergoing general anesthesia
  • Allergy or intolerance to one of the study medications
  • Chronic gabapentin/pregabalin use ( regular use for longer than 3 months)
  • Chronic opioid use ( taking opioids for longer than 3 months, or daily oral morphine equivalent of >5 mg/day one month

结局指标

主要结局

Numerical Rating Scale (NRS) scores

时间窗: 48 Hours

Range 0-10, 0=no pain, 10=the worse pain ever

次要结局

  • Opioid consumption(3-6-8-12-24 and 48 hours)
  • Patient satisfaction(48 hours)
  • Presence of quadriceps motor block (defined as paralysis or paresis )(3-6-12-24 hours after the block)
  • Mobilization time(24 hour)
  • Static and dynamic pain(3-6-8-12-24 and 48 hours)
  • Hip adduction strength(3-6-12-24 hours after the block)
  • Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression(3-6-12-24 hours after the block)
  • Quality of Recovery (QoR-40) score(measurements are obtained at 24 hours, 48 hours, and one week)

研究者

发起方
Karaman Training and Research Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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