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临床试验/NCT04402437
NCT04402437已完成不适用

Utilization of Quadratus Lumborum Versus Lumbar Plexus Blocks for Postoperative Analgesia Following Hip Arthroplasty: A Prospective, Randomized Clinical Trial

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2020年7月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
111
试验地点
2
主要终点
Opioid consumption

研究概览

简要总结

Purpose: Evaluate difference in postoperative opioid consumption when subjects receive a quadratus lumborum (QL) or lumbar plexus (LP) block preoperatively for total hip arthroplasty (THA).

Hypothesis: Preoperative QL and LP blocks will result in similar postoperative opioid consumption following hip arthroplasty.

详细描述

With the goal of improving physical function and quality of life, the demand for total hip arthroplasty (THA) continues to grow. However, postoperative pain associated with THA remains a serious concern for patients. In the middle of a growing opioid epidemic, multimodal approaches utilizing both non-opioid analgesics and regional anesthetic techniques are being increasingly sought.

Regional anesthetic techniques are associated with both decreased opioid consumption and pain scores compared with systemic analgesia alone. However, regional techniques for THA are seldom compared. Lumbar plexus blocks are commonly performed for postoperative analgesia for THA. However, more recent case reports have described utilizing quadratus lumborum blocks for analgesia following hip fracture and THA.

This prospective study would randomize subjects to receive a lumbar plexus block or quadratus lumborum block prior to THA. The primary end point would be opioid consumption at 12 hours postoperative. Our hypothesis is that opioid consumption will not differ between groups.

The quadratus lumborum block is a fascial plane block. Originally described for abdominal surgery, numerous case reports and editorial publications have highlighted the effectiveness of quadratus lumborum (QL) blocks as an analgesic technique for hip fracture and hip arthroplasty. However, prospective randomized studies comparing QL blocks to other regional techniques for THA analgesia are lacking.

The lateral approach to the QL block is performed by injecting local anesthetic deep to the transversus abdominus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. After completing consent, placing monitors and providing mild sedation, the subject is positioned laterally and the muscular anatomy (external oblique, internal oblique, transverse abdominis, quadratus lumborum and latissimus dorsi muscles) identified. After placing a subcutaneous skin wheal with lidiocaine, a blunt regional anesthesia needle is inserted using in-plane ultrasound guidance. Local anesthetic is deposited incrementally with frequent aspiration in the anterolateral border of the quadratus lumborum muscle at the junction of the transversalis fascia, outside the anterior layer of the thoracolumbar fascia and superficial to the fascia transversalis.

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
Single (Participant)

盲法说明

All subjects will be positioned, prepped and sedated for the randomized regional anesthesia procedure in the preoperative holding area. The subject will be positioned in the lateral decubitus position with the operative side up and pulse oximetry and blood pressure cuff placed for monitoring. As part of routine care, the subject will receive sedation for their comfort. All subjects would receive 20 ml of 0.5% ropivacaine in their nerve block regardless of randomization. The relevant anatomy will then be identified using either surface landmarks (lumbar plexus block) or an ultrasound (quadratus lumborum block). Surface anatomy will be marked with a marking pen for both groups to keep the intraoperative and surgical team blinded. The skin will be cleaned with chlorhexidine. Subject, surgeon, intraoperative anesthesia team and data collectors would all be blinded to the allocated group.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age greater than or equal to 18 years-old
  • Undergoing elective hip arthroplasty.

排除标准

  • Local anesthetic allergy
  • Chlorhexidine allergy
  • Subjects with a weight less than 40kg
  • Subjects that are unable or choose not to give informed consent
  • Emergency surgery
  • Known preoperative substance abuse
  • Allergy to all opioids

结局指标

主要结局

Opioid consumption

时间窗: 12 hours

Opioid consumption including intraoperative consumption

次要结局

  • Opioid consumption 8 hours postoperative(8 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sylvia Wilson

Associate Professor

Medical University of South Carolina

研究点 (2)

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