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临床试验/NCT07138794
NCT07138794已完成不适用

Ultrasound-Guided Subtransverse Interligamentary Block Versus Thoracic Paravertebral Block for Postoperative Analgesia in Patients Undergoing Open Nephrectomy: A Randomized Clinical Trial

Tanta University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年8月23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
70
试验地点
1
主要终点
Total morphine consumption

研究概览

简要总结

This study aims to compare ultrasound-guided subtransverse process interligamentary (STIL) block versus thoracic paravertebral block (TPVB) for postoperative analgesia in patients undergoing open nephrectomy.

详细描述

Acute pain physiopathology is explained as it is mediated by inflammatory cell infiltration, activation of spinal cord pain pathways, and also by reflexive muscle spasm. All of these three mechanisms of acute pain are typically ameliorated during the postoperative recovery.

A thoracic paravertebral block (TPVB) shows comparable analgesic efficacy with fewer side effects compared with thoracic epidural analgesia in patients undergoing thoracotomy.

The recently introduced subtransverse process interligamentary (STIL) block offers a safer alternative by targeting thoracic nerves without entering paravertebral space.

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)

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
否

入选标准

  • •Age from 18 to 65 years.
  • •Both sexes.
  • •American Society of Anesthesiology (ASA) physical status I-III.
  • •Undergoing open nephrectomy under general anesthesia.

排除标准

  • •History of allergies to local anesthetics.
  • •Opioid dependency.
  • •Bleeding or coagulation disorders.
  • •Psychiatric and neurological disorder.
  • •Local infection at the site of injection.
  • •Body mass index (BMI) > 35 kg/m
  • •Severe heart, lung, liver, and renal dysfunction.
  • •Pregnant or lactating women.

研究组 & 干预措施

STIL group

Experimental

Patients will receive subtransverse process interligamentary (STIL) block using 20ml of bupivacaine 0.25%.

干预措施: Subtransverse process interligamentary (Other)

TPVB group

Experimental

Patients will receive a thoracic paravertebral block (TPVB) using 20ml of bupivacaine 0.25%.

干预措施: Thoracic paravertebral block (Other)

结局指标

主要结局

Total morphine consumption

时间窗: 48 hours postoperatively

Rescue analgesia of morphine will be given as 3 mg bolus if the numeric rating scale (NRS) \> 3 to be repeated after 30 min if pain persists until the NRS \< 4.

次要结局

  • Time to the 1st rescue analgesia(48 hours postoperatively)
  • Mean arterial pressure(Till the end of surgery (Up to 2 hours))
  • Heart rate(Till the end of surgery (Up to 2 hours))
  • Intraoperative fentanyl consumption(Intraoperatively)
  • Degree of pain(48 hours postoperatively)
  • Incidence of adverse events(48 hours postoperatively)

研究者

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

Mohammed Said ElSharkawy

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Tanta University

研究点 (1)

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