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临床试验/NCT05710107
NCT05710107已完成不适用

The Impact or Quadratum Lumborum (QL) Block Versus Pericapsular Nerve Group (PENG) With Lateral Femoral Cutaneous (LFC) Nerve Blocks for Analgesia After 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 106 人开始时间: 2023年2月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
106
试验地点
2
主要终点
Postoperative Cumulative Opioid Consumption

研究概览

简要总结

This study will consist of patients 18 years and older who are undergoing elective hip replacement with planned same day discharge. The patients will be randomized to receive a PENG+LFC or QL block prior to undergoing the surgery to help with postoperative pain control. The primary goal will be assessing postoperative opioid use during the first 72 hours after surgery. Secondary outcomes will include postoperative pain scores from, 0-72 hours. Additional outcomes consist of time to first ambulation, functional and mobility outcomes, PACU duration, patient satisfaction and opioid related side effects.

详细描述

  1. Patients demographic data and health information will be collected including age, height, weight, and details related to injury from the medical record. Patients will also be asked to complete a set of questionnaires detailing how they feel prior to the procedure.
  2. Patients will be randomly assigned to one of two groups. Group A will receive the PENG + LFC block. Group B will receive the QL block. Patients will be sedated while receiving either block.

If patients are assigned to the QL block, ultrasound technology will be used to identify appropriate structures on the side of the abdomen. An injection of lidocaine (numbing medication) into the skin will be inserted first for comfort. A second needle will be inserted into the side of the abdomen and a numbing medication called ropivacaine will be injected.\

If patients are randomized to receive PENG + LFC, ultrasound technology will be used to identify appropriate structures between the hip and groin area. An injection of lidocaine (numbing medication) into the skin will be inserted first for comfort. A needle will be inserted to the appropriate location between the hip and groin, and a numbing medication called ropivacaine will be injected. This may take more than one injection in the same area. 3. Surgery will begin shortly after the placement of the nerve block(s). 4. Before being discharged from the surgery center, patients will be asked their current pain score (0-100) and the study team will provide a detailed information sheet that includes instructions for the study follow-up period. Patients will receive a text message with a link to a questionnaire at 9:00 AM, and 3:00 PM for the first three days after surgery. This questionnaire will ask them to rate their average pain at rest and while moving in a specific time period by using a visual scale from 0-100. The study will also ask questions about the pain medication taken in that same time period. At day 7, participants will receive a survey link via text message with additional questions about recovery. If they do not wish to be contacted by text message, someone from the study team will contact them by telephone at the end of the seven days and ask them to read back the information recorded on the paper data sheet provided. 5. At approximately 2-3 weeks after surgery, and again at approximately 6 weeks after surgery a study team member will contact patients either via telephone or visit patients during their post-surgical clinic visit to complete a set of questionnaires related to their recovery. Patients will also be asked to report any side effects, urgent care/emergency room visits, or any new conditions while participating in the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Subjects, surgeons, and data collectors will all be blinded to the allocated group. Unblinded personnel will be the Anesthesia Attending placing the block and clinical staff assisting.

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 of age
  • undergoing elective hip arthroplasty with planned same day discharge

排除标准

  • local anesthetic allergy
  • subjects with a weight less than 40kg
  • subjects that are unable or choose not to give informed consent
  • Known preoperative substance abuse

研究组 & 干预措施

QL Block

Active Comparator

The lateral QL block is performed by injecting local anesthetic deep to the transversus abdominis aponeurosis and superficial to the fascia transversalis with direct ultrasound guidance. After completing consent, placing monitors and providing mild sedation, the patient 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 wheel with lidocaine, 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.

干预措施: QL Block (Other)

PENG + LFC Block

Active Comparator

The pericapsular nerve group (PENG) block is an ultrasound-guided approach, first described by Giron-Arango et al. for the blockade of the articular branches of the femoral, obturator and accessory obturator nerves that provide sensory innervation to the anterior hip capsule [5,6]. In the PENG block, a low-frequency, curvilinear probe is used to visualize the anterior inferior iliac spine, iliopsoas tendon, and iliopubic eminence. After placing a subcutaneous skin wheel with lidocaine, a blunt regional anesthesia needle is inserted using in-plane ultrasound guidance. The needle is advanced until the tip lies on the lateral and inferior margin of the iliopsoas tendon between the anterior inferior iliac spine (lateral) and iliopubic eminence (deep).

干预措施: PENG + LFC Block (Other)

结局指标

主要结局

Postoperative Cumulative Opioid Consumption

时间窗: 0-72 hours postoperatively

The primary outcome will be postoperative cumulative opioid consumption (in IV morphine mg equivalents: IV MME) over time, from 0-72 hours postoperatively. Cumulative opioid consumption will be evaluated at PACU, and through 72 hours post-op.

次要结局

  • Average Postoperative Pain Score(0-72 hours postoperatively)

研究者

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

Ellen Hay

Principal Investigator

Medical University of South Carolina

研究点 (2)

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