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临床试验/NCT07201272
NCT07201272已完成不适用

Ultrasound-Guided Transversalis Fascia Plane Block Versus Intrathecal Morphine for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized Clinical Trial

Tanta University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年10月1日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Time to the 1st rescue analgesia

研究概览

简要总结

This study aims to compare the ultrasound-guided transversalis fascia plane (TFP) block and intrathecal morphine for postoperative analgesia in patients undergoing total abdominal hysterectomy (TAH).

详细描述

Total abdominal hysterectomy (TAH) is a commonly performed major surgical procedure that results in substantial postoperative pain and discomfort. Postoperative pain, if not treated promptly, can impair the patient's ability to ambulate which may lead to adverse effects such as thromboembolism, myocardial ischemia, and arrhythmia.

Intrathecal opioids are synergistic with local anesthetics and intensify the sensory block without increasing the sympathetic block. Morphine, which is relatively less hydrophobic than other opioids, has a longer residence time in the cerebrospinal fluid and therefore may reach rostral sites over a longer period than other opioids.

Ultrasound-guided interfascial plane blocks are often used in multimodal analgesia regimens. Local anaesthetic injection into the transversalis fascia plane (TFP) anesthetizes the proximal branches of T12 and L1 which targeted in the plane between the transversus abdominis muscle and the transversalis fascia.

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

入选标准

  • Age from 18 to 65 years.
  • American Society of Anesthesiology (ASA) physical status I-II.
  • Women undergoing total abdominal hysterectomy (TAH) under spinal anesthesia.

排除标准

  • History of allergies to local anesthetics.
  • Local infection at the site of injection.
  • Bleeding disorders.
  • History of chronic use of analgesic.
  • Physical or mental conditions.
  • Hepatic, renal or cardiac disease.
  • Contraindication to spinal anesthesia.

研究组 & 干预措施

TFP group

Experimental

Patients will receive spinal anesthesia (using 3.5 mL of hyperbaric bupivacaine 0.5%) with bilateral transversalis fascia plane (TFP) block (using 20 mL of bupivacaine 0.25%) at the end of surgery.

干预措施: Transversalis fascia plane block (Other)

IM group

Experimental

Patients will receive spinal anesthesia (using 3 mL of hyperbaric bupivacaine 0.5%) + (75 µg morphine diluted in 0.5ml saline) with sham block at the end of surgery.

干预措施: Morphine (Drug)

结局指标

主要结局

Time to the 1st rescue analgesia

时间窗: 24 hours postoperatively

Time to the first request for the rescue analgesia (time from the end of surgery to first dose of morphine administrated).

次要结局

  • Total morphine consumption(24 hours postoperatively)
  • Degree of pain(24 hours postoperatively)
  • Incidence of adverse events(24 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 (2)

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