Effect of Adding Dexmedetomidine as Adjuvant to Bupivacaine in Ultrasound Guided External Oblique Intercostal Plane Block in Upper Abdominal Cancer Surgery. A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 54
- 主要终点
- Total Postoperative Opioid Consumption (mg of morphine equivalents)
研究概览
简要总结
Effect of Adding Dexmedetomidine as Adjuvant toBupivacaine in Ultrasound Guided ExternalOblique Intercostal Plane Block in UpperAbdominal Cancer Surgery.
详细描述
Effect of Adding Dexmedetomidine as Adjuvant toBupivacaine in Ultrasound Guided ExternalOblique Intercostal Plane Block in UpperAbdominal Cancer Surgery. A prospectiverandomized clinical trial
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-70 years scheduled for elective upper abdominal cancer surgery (e.g., gastrectomy, hepatectomy, pancreatectomy).
- •American Society of Anesthesiologists (ASA) physical status I-III.
- •Body mass index (BMI) between 18-35 kg/m².
排除标准
- •Patient refusal.
- •Allergy to local anesthetics or dexmedetomidine.
- •Coagulopathy (INR >1.5, platelet count <100,000/mm³).
- •Infection at the injection site.
- •Severe cardiopulmonary, renal, or hepatic dysfunction.
- •Chronic opioid use (>30 mg morphine equivalents daily for >3 months).
- •Pregnancy or lactation.
研究组 & 干预措施
Dexmedetomidine + Bupivacaine
Participants will receive an ultrasound-guided external oblique intercostal plane block using 20 mL of 0.25% bupivacaine combined with dexmedetomidine (0.5 µg/kg) administered as a single-shot injection.
干预措施: Dexmedetomidine (Drug)
Bupivicaine
Participants will receive an ultrasound-guided external oblique intercostal plane block using 20 mL of 0.25% bupivacaine administered as a single-shot injection without any adjuvant.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Total Postoperative Opioid Consumption (mg of morphine equivalents)
时间窗: 24 hours postoperative.
To evaluate the effect of adding dexmedetomidine to bupivacaine on total opioid consumption within the first 24 hours after upper abdominal cancer surgery.
次要结局
- Postoperative Pain Intensity Using the Visual Analog Scale (VAS 0-10)(2, 4, 6, 12, 18, and 24 hours postoperative.)
- Time to First Request for Rescue Analgesia.(24 hour postoperative)
- Number of Participants with Adverse Effects(first 2 hours postoperative.)
- patient satisfaction score(1 hour postoperative)
- Block-related complications.(intraoperative and 24 postoperative)
研究者
Mohamed Ibrahem Shaker
Anesthesia Resident
Assiut University