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临床试验/NCT07055438
NCT07055438已完成不适用

Analgesic Efficacy of Ultrasound Guided Bilateral External Oblique Intercostal Plane Block Versus Rectus Sheath Block in Upper Abdominal Surgeries: A Randomized Double-blinded Controlled Study

Kasr El Aini Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年7月24日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Time to first request for rescue analgesia

研究概览

简要总结

The current study is designed to investigate the analgesic potentials of two modalities of abdominal blocks where local anesthetics is injected in the fascial planes of the abdominal muscles to anesthetize the nerves supplying the abdomen in patients undergoing upper abdomial surgeries.

the two modalities are the rectus sheath block (RSB) and the external oblique intercostal plane block (EOIPB). The investigators are going to use the ultrasound to identify the muscles and inject the local anesthetics. The investigators suggest that the EOIPB might provide better pain control when compared to RSB.

详细描述

Fascial plane blocks emerge as an appealing technique to provide good intraoperative and postoperative analgesia in patients undergoing upper abdominal surgeries. Such techniques have the benefit of decreasing opioids use and consequently reducing the like hood of their side effects.

Ultrasound guided rectus sheath Block (RSB) targets the terminal branches of thoracic nerves thus providing analgesia for midline abdominal incisions.

Ultrasound guided external oblique intercostal plane block (EOIPB), a relatively new technique, targets the lateral cutaneous branches of the thoracoabdominal nerves providing analgesia for anterolateral and upper median plane of the abdomen.

Studies Comparing both techniques are deficient, that is why the investigators designed the current study to evaluate and compare the analgesic efficacy of both techniques in upper abdominal surgeries namely Whipple operation and total gastrectomy.

The study is a randomized controlled double blinded trial comprising two groups. The RSB group will receive bilateral ultrasound guided rectus sheath block with 20ml of 0.25% bupivacaine on each side. The EOIB group will receive bilateral ultrasound guided External oblique intercostal plane block with 20ml of 0.25% bupivacaine on each side as well. Both blocks will be performed after administering general anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

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
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status II, III.
  • Patients who will undergo upper abdominal surgeries (Whipple operation, total gastrectomy).

排除标准

  • Coagulation disorders.
  • Abdominal surgery history.
  • Infection in the block application area.
  • Chronic opioid use.
  • Local anesthetic (LA) allergy.
  • Pregnancy.
  • BMI ≥35 kg/m
  • Severe cardiovascular problems.
  • Diabetic neuropathy.
  • Complicated surgeries with massive blood loss and hemodynamic instability.

结局指标

主要结局

Time to first request for rescue analgesia

时间窗: Time in hours from end of surgery to first dose of morphine administered up to 24 hours postoperatively

Time from end of surgery to first dose of morphine administered

次要结局

  • Fentanyl consumption(From the start of the surgery till the end in micogram/Kg)
  • Postoperative morphine consumption(from the time numerical rating scale exceeds 3 and till 24 hours after the end of the surgery)
  • Patient satisfaction of analgesia(2 hours after recovery from anesthesia)
  • Pain score(from the time of recovery immediately in the postoperative period and then at 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours postoperatively)
  • Incidence of postoperative nausea and vomiting(From the recovery of anesthesia and up to 24 hours postoperatively)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rania Samir Fahmy

Associate professor of Anesthesia, intesive care and pain management - Kasr El Aini Hospital

Kasr El Aini Hospital

研究点 (2)

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