A Comparative Study of Dexmedetomidine Versus Fentanyl as Adjuvants to Bupivacaine in Ultrasound Guided Transversus Abdominis Plane Block in Patients Undergoing Radical Cystectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- The time for first rescue analgesia after the TAP block.
研究概览
简要总结
The aim and objective of this study is to compare dexmedetomidine and fentanyl as adjuvants to bupivacaine in ultrasound guided TAP block analgesia in patients undergoing radical cystectomy as regarding postoperative analgesic efficacy.
详细描述
Radical cystectomy with pelvic lymph node dissection is the gold standard treatment for muscle invasive bladder cancer and is associated with a high risk of complications. Management of the postoperative pain is important to decrease the length of stay in the hospital and the risk of morbidity. Multimodal analgesia management is utilized for pain observed in the postoperative period.As part of a multimodal analgesic regimen, a peripheral nerve block can decrease opioid consumption, providing more effective analgesia with fewer adverse effects.TAP block is a relatively new regional anesthesia technique that provides analgesia to the parietal peritoneum, as well as skin and muscles of the lower anterior abdominal wall. Dexmedetomidine and fentanyl have been used as adjuvants to local anesthetics in different surgeries to provide superior analgesia and to improve the duration of the block.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both sexes.
- •ASA grade I and II.
- •Age between 50-70 years.
- •Elective open radical cystectomy.
排除标准
- •Any history or signs of cardiac, hepatic and renal failure.
- •Patients with coagulopathy or under anticoagulation therapy.
- •Infection near the site of needle insertion.
- •Morbid obesity (BMI>40 kg/m2).
- •History of allergic reactions to any of the study medications.
- •Previous abdominal surgery.
- •Patients with any neurological or neuromuscular disorder or history of seizures.
研究组 & 干预措施
Group(B)
Patients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% on each side.
干预措施: Bupivacaine (Drug)
Group(BD)
Patients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg dexmedetomedine on each side.
干预措施: Dexmedetomidine (Drug)
Group(BF)
Patients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg fentanyl on each side.
干预措施: Fentanyl (Drug)
结局指标
主要结局
The time for first rescue analgesia after the TAP block.
时间窗: first 24 hours after block.
Postoperative analgesia duration.
次要结局
- the total dose of rescue analgesia after TAP bock.(first 24 hours after block.)
- VAS for pain.(0, 2, 4, 6, 12 and 24 hours postoperatively.)
研究者
Dina Mahmoud Fakhry
Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management
Beni-Suef University
