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临床试验/NCT06703229
NCT06703229已完成不适用

Assessment of the Impact of Two Dexmedetomidine Dosages Added with Bupivacaine in Ultrasound-Guided Transversus Abdominis Plane Block for Postoperative Analgesia Following Inguinal Hernia Repair: Randomized Controlled Study

Helwan University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年1月15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
100
试验地点
1
主要终点
the initial request for analgesia post-surgery

研究概览

简要总结

The principal outcome assessed was the duration until the initial request for analgesia post-surgery. The secondary outcomes encompassed the total quantity of analgesics administered (ketorolac, paracetamol, and morphine) within the initial 24 hours. Pain levels, measured using the Visual Analogue Scale (VAS), were evaluated at rest and during movement at many intervals following surgery (1, 6, 12, and 24 hours). The study also observed postoperative complications, such as emesis, hypotension, bradycardia, and pruritus.

详细描述

One of the most frequently performed surgical procedures worldwide is the repair of an open inguinal hernia, with a postoperative pain severity of moderate to severe affecting over 60% of patients. Post-surgical analgesia frequently employs a multifaceted approach, incorporating oral pharmacotherapy and regional anesthetic procedures. Opioids are a conventional option for postoperative pain management; nevertheless, their administration is linked to adverse effects such as nausea, vomiting, sleepiness, pruritus, and respiratory depression, which may impede the recovery process. Non-opioid alternatives, however, can improve patient rehabilitation and overall outcomes. The Transversus Abdominis Plane (TAP) block efficiently reduces early postoperative discomfort and decreases narcotic usage, which is a significant advantage for patients undergoing inguinal hernia repair. To alleviate pain in the abdominal wall muscles, peritoneum, and skin, this treatment involves administering a local anesthetic into the space between the transversus abdominis and internal oblique muscles.]2[

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

入选标准

  • with ASA physical status I or II
  • scheduled for elective unilateral inguinal hernioplasty under spinal anesthesia
  • aged 18 to 60 years
  • both genders

排除标准

  • patient refusal, BMI ≥ 40 kg/m2 incapacity to engage in pain assessment contraindications to spinal anesthesia (e.g., coagulopathy, skin infection)
  • and intolerance to the research medications.

研究组 & 干预措施

group, D1

Active Comparator

group, D1, had a TAP block that included 0.5 µg/kg of dexmedetomidine and bupivacaine

干预措施: The Transversus Abdominis Plane (TAP) block (Drug)

group, D2

Active Comparator

group, D2, received the same block but with 1 µg/kg of dexmedetomidine.

干预措施: The transverse abdominis plane (TAP) block (Drug)

结局指标

主要结局

the initial request for analgesia post-surgery

时间窗: 24 hours

The postoperative Visual Analogue Scale (VAS) is a 10 cm horizontal line labeled "no pain" at one end and "worst pain" on the other end.

次要结局

未报告次要终点

研究者

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

Adel Ali Hassan

Lecturer of Anesthesia, Surgical Intensive Care and Pain Management, Faculty of Medicine, Port Said University

Port Said University

研究点 (1)

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