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临床试验/NCT06654635
NCT06654635招募中不适用

Comparison Between Ultrasound Guided Rhomboid Intercostal Plane Block and Thoracic Erector Spinae Plane Block in Patients Undergoing Upper Abdominal Surgery: A Randomized Controlled Trial

Tanta University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Total morphine consumption

研究概览

简要总结

The aim of the work is to evaluate the analgesic efficacy of ultrasound guided rhomboid intercostal plane block versus ultrasound guided thoracic erector spinae block in patients undergoing upper abdominal surgery.

详细描述

Abdominal surgery is one of the most definitive and mainstay treatment options for abdominal pathologies in clinical practice. Acute postoperative pain is a major challenge in the postoperative period.

The improved safety and efficacy that ultrasound brings to regional anesthesia helped promote its use and realize the benefits that regional anesthesia has over general anesthesia, such as decreased morbidity and mortality, superior postoperative analgesia, cost-effectiveness, decrease postoperative complications and an improved postoperative course .

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
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 21-65 years.
  • Both gender.
  • American Society of Anesthesiologists (ASA) classification I-II.
  • Presented for elective upper abdominal surgery.

排除标准

  • Patients refused to participate.
  • Patients with known or suspected allergy to the used medication.
  • Patients with preoperative chronic pain.
  • Patients with major cardiac, renal, respiratory, or hepatic disease.
  • Patients with potential risk of coagulopathy.
  • Obese patients with body mass index (BMI) >35.

研究组 & 干预措施

Rhomboid intercostal plane block group

Experimental

The patients in this group will receive ultrasound -guided rhomboid intercostal plane block after induction of general anesthesia. The rhomboid intercostal block will be performed at the T6 levels, bilaterally.

干预措施: Rhomboid intercostal plane block (Drug)

Erector spinae plane block group

Experimental

The patients in this group will receive ultrasound -guided Erector spinae plane block after induction of general anesthesia. ESP block will be performed at the level of T9 bilaterally.

干预措施: Erector spinae plane block (Other)

Control group

Experimental

No block will be performed, and patient will receive general anesthesia (GA) only.

干预措施: Control group (Other)

结局指标

主要结局

Total morphine consumption

时间窗: 24 hours postoperatively

Rescue analgesia will be provided in the form of IV morphine 3 mg boluses if the patient indicates The visual analogue scale (VAS). ≥ 4 with maximum dose 20 mg for 24 hours. The total amount of morphine (mg) given will be recorded for the 3 groups.

次要结局

  • Degree of pain(24 hours postoperatively)
  • Time to 1st request of rescue analgesia(24 hours postoperatively)
  • Heart rate(Every 15 min till the end of surgery)
  • Mean arterial blood pressure(Every 15 min till the end of surgery)
  • Incidence of side effects(24 hours Postoperatively)

研究者

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

Omima Mohammed Fakher Eldin Ali

Assistant 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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