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临床试验/NCT06363578
NCT06363578已完成不适用

Comparing the Analgesic Effects of Different Doses of Dexmedetomidine as an Adjuvant in External Oblique Intercostal Plane Block in Splenectomy: A Randomized Trial

Tanta University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年4月20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
50
试验地点
1
主要终点
Time to the 1st rescue analgesia

研究概览

简要总结

The aim of this study is to compare the analgesic effects of different doses of dexmedetomidine as an adjuvant in external oblique intercostal plane block (EOIPB) in splenectomy.

详细描述

External oblique intercostal plane block (EOIPB) was reported by Elsharkawy et al . It is a novel block, which has been described as an important modification of the fascial plane blocks that can consistently involve the upper lateral abdominal walls. In comparison to quadratus lumborum block (QLB) and erector spinae plane block (ESPB) , EOIPB has the benefit of being performed when the patient is supine. It also has an advantage over serratus intercostal plane block (SIPB) in that it produces greater analgesia throughout the midline of the abdomen.

Dexmedetomidine is used for sedation in patients admitted to the intensive care unit (ICU). Dexmedetomidine is a selective alpha 2- adrenoceptor agonist possessing sedative, anxiolytic, and analgesic properties without the development of respiratory depression . Several studies have shown that dexmedetomidine has an anesthetic sparing effect, which has led to its use as a general adjuvant for prolonging peripheral nerve block duration.

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, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years.
  • Both sexes.
  • American Society of Anesthesiology (ASA) physical status II-III.
  • Scheduled for splenectomy.

排除标准

  • Body mass index (BMI) ≥35 kg/m2
  • History of abdominal surgery.
  • Infection at the injection site.
  • Drug abuse.
  • Allergic reaction to local anesthetics.
  • Coagulation abnormalities.
  • Pregnancy.
  • Severe cardiovascular problems.
  • Diabetic neuropathy.

研究组 & 干预措施

Group dexmedetomidine 0.5

Experimental

Patients will receive 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 0.5 μg/kg diluted in saline.

干预措施: Dexmedetomidine 0.5 μg/kg (Drug)

Group dexmedetomidine1

Experimental

Patients will receive 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 1 μg/kg diluted in saline.

干预措施: Dexmedetomidine 1 μg/kg (Drug)

结局指标

主要结局

Time to the 1st rescue analgesia

时间窗: 48 hour Postoperatively

Rescue analgesia of morphine will be given as 3 mg bolus if the numeric rating scale (NRS) \> 3 to be repeated after 30 min if pain persists until the NRS \< 4. NRS will be assessed at 0, 4, 8, 12, 18, 24, 36 and 48 h postoperatively. Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").

次要结局

  • Heart rate(Till the end of surgery)
  • Intraoperative fentanyl consumption(Intraoperatively)
  • Mean arterial pressure(Till the end of surgery)
  • Total morphine consumption(48 hour postoperatively)
  • Degree of pain(48 hours postoperatively)
  • The incidence of adverse events(48 hour 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 (1)

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