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临床试验/NCT07842861
NCT07842861已完成不适用

Comparative Study Between Morphine and Dexmedetomidine as Adjuvants to Bupivacaine in TAP Block in Lower Abdominal Surgeries: A Randomized Double-Blinded Clinical Study

Cairo University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年12月1日最近更新:
适应症
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
70
试验地点
1
主要终点
Duration of analgesia

研究概览

简要总结

This study aimed to ascertain the safety and efficacy of dexmedetomidine in comparison to morphine as adjuvants to bupivacaine during transversus abdominis plane (TAP) block in postoperative pain management in adult patients undergoing lower abdominal surgery.

详细描述

Postoperative pain is a significant contributor to higher morbidity, patient discomfort, and extended hospital stays.

The ultrasound-guided transversus abdominis plane (TAP) block has become more popular than systemic analgesics for reducing pain following abdominal surgery.

A plethora of adjuvants, including but not limited to morphine, fentanyl, and dexmedetomidine, have been incorporated into various regimens of TAP block, yielding disparate outcomes.

The use of alpha-2 agonist dexmedetomidine has been sanctioned for its application as an adjuvant in the management of pain and as a venous sedative.

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 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age from 18 to 60 years.
  • •Both genders.
  • •Classified according to the American Society of Anesthesiologists physical status (ASA) classification system as I-II.
  • •Body mass index (BMI) of less than
  • •Patients scheduled to undergo elective surgical procedures on the lower abdominal region.

排除标准

  • •Patients with hypersensitivity to the utilized pharmaceutical agents.
  • •Mental disorders.
  • •Serious pulmonary or cardiac disease.
  • •Severe renal insufficiency.
  • •Coagulopathy.
  • •Infection at the injection site.

研究组 & 干预措施

Group D

Experimental

Patients received transversus abdominis plane (TAP) block with bupivacaine 0.25% plus a dose of 1 µg/kg of dexmedetomidine.

干预措施: Transversus abdominis plane block + Dexmedetomidine (Drug)

Group M

Experimental

Patients received a dose of 10 mg of morphine.

干预措施: Morphine (Drug)

结局指标

主要结局

Duration of analgesia

时间窗: 24 hours postoperatively

Duration of analgesia was defined as the time interval from the end of the surgical procedure to the administration of the initial dose of morphine.

次要结局

  • Total opioid dose required(24 hours postoperatively)
  • Degree of pain(24 hours postoperatively)
  • Incidence of adverse events(24 hours postoperatively)
  • Degree of patient satisfaction(24 hours postoperatively)

研究者

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

Heba Mahmoud Raafat

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management, Faculty of Medicine, Cairo University, Egypt

Cairo University

研究点 (1)

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