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临床试验/NCT06298227
NCT06298227已完成不适用

The Comparison of Erector Spinae Plane Block and Quadratus Lumborum Block on Postoperative Analgesia in Patients Undergoing Laparoscopic Nephrectomy: A Randomized, Prospective, Controlled Study

Istanbul Medipol University Hospital2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2024年3月11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
发起方
入组人数
62
试验地点
2
主要终点
Amount of total opioid consumption (Fentanyl PCA) at the first 24 hours period postoperatively

研究概览

简要总结

Ultrasound (US) guided Quadratus Lumborum Block (QLB) is performed at the level of the 12th rib, in the parasagittal oblique plane, at the L1-L2 level. As there are modifications of the block generally local anesthetic is given between quadratus lumborum (QL) and psoas major (PM) muscles (Anterior QLB). The QLB provides a sensory block between T7 - L1. Therefore, QLBs are used to provide postoperative analgesia for abdominal, obstetric, gynecologic, and urologic surgeries.

US-guided erector spinae plane block (ESPB) is performed at the level of the T11 transverse process. After visualization of the erector spinae (ES) muscle and the transverse process, local anesthetic is injected under the ES muscle. ESPB provides a sensory block of the anterior, posterior, and lateral thoracic and abdominal walls accordingly it's used for postoperative analgesia after thoracal wall repairs, thoracotomies, percutaneous nephrolithotomies, nephrectomies, and ventral hernia repairs.

This study aims to compare the effectiveness of US-guided ESPB and QLB on postoperative pain control after laparoscopic nephrectomy.

详细描述

Nephrectomy for renal transplantation is a commonly performed procedure. The laparoscopic live donor nephrectomy (LLDN) is associated with many benefits and has become the gold standard for kidney retrieval surgery. As compared to open donor nephrectomy (ODN), LLDN has been shown to have less post-operative pain, shorter hospital stays, and faster recovery. Even though LLDN is less traumatic, some patients undergoing laparoscopic live donor nephrectomy still suffer significant postoperative pain require parenteral opioids, and have a risk for chronic pain.

The postoperative pain mechanism of LLDN is multifactorial - port pain, pain caused by incisions to retrieve the kidney, pelvic organ nociception, diaphragmatic irritation, and discomfort of a urinary catheter. Opioids, epidural anesthesia, Transversus Abdominal Plane (TAP) Block, and local infiltration of local anesthetics are used to prevent postoperative pain after LLDN.

In this study, the investigators aim to compare the effectiveness of US-guided ESPB and QLB on postoperative pain control after laparoscopic nephrectomy.

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
Double (Participant, Outcomes Assessor)

盲法说明

Outcomes assessor and participants will be blinded to the study

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) classification I-II
  • Scheduled for living donor laparoscopic nephrectomy under general anesthesia

排除标准

  • history of bleeding diathesis,
  • receiving anticoagulant treatment,
  • known local anesthetics and opioid allergy,
  • infection of the skin at the site of the needle puncture,
  • pregnancy or lactation,
  • patients who refuse the procedure or participation in the study

研究组 & 干预措施

Group ESPB = Erector spinae plane block group

Active Comparator

ESPB will be performed

干预措施: Postoperative analgesia management with Paracerol® and IV PCA with Talinat® (Other)

Group ESPB = Erector spinae plane block group

Active Comparator

ESPB will be performed

干预措施: Erector spinae plane block (Other)

Group QLB = Quadratus lumborum block group

Active Comparator

QLB will be performed

干预措施: Postoperative analgesia management with Paracerol® and IV PCA with Talinat® (Other)

Group QLB = Quadratus lumborum block group

Active Comparator

QLB will be performed

干预措施: Quadratus lumborum plane block (Other)

结局指标

主要结局

Amount of total opioid consumption (Fentanyl PCA) at the first 24 hours period postoperatively

时间窗: Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.

The primary aim is to compare postoperative opioid consumption from the PCA device.

次要结局

  • Need for rescue analgesia (meperidine)(Postoperative 24 hours period)
  • Adverse events(Postoperative 24 hours period)
  • Pain scores (Numerical rating scale-NRS)(Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours)

研究者

发起方
Istanbul Medipol University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayse Ince

Principal Investigator

Istanbul Medipol University Hospital

研究点 (2)

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