Dexmedetomidine as an Adjuvant to Bupivacaine in Scalp Block Versus Bupivacaine Alone for Postoperative Pain Management in Patients Undergoing Craniotomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Cumulative postoperative morphine consumption
研究概览
简要总结
This study aims to compare dexmedetomidine as an adjuvant to bupivacaine in scalp block versus bupivacaine alone for postoperative pain management in patients undergoing craniotomy.
详细描述
Scalp block is proposed as a multimodal approach to preventing postoperative pain and hemodynamic responses to previous noxious stimulation during the operation.
The use of adjuvants, such as dexmedetomidine, a highly selective alpha-2 adrenergic receptor agonist, has recently been studied for its analgesic effects. Dexmedetomidine acts additionally to local anesthetics, prolonging their duration of action.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 65 years.
- •Both sexes.
- •American Society of Anesthesiologists (ASA) physical status I or II.
- •Undergoing supratentorial elective planned craniotomies.
排除标准
- •Patients refusal.
- •History of known allergy to the used local anesthetic or dexmedetomidine.
- •Bleeding disorders.
- •Evidence of local infection at the site of injection.
- •Emergency craniotomy.
- •Psychotic disorder.
- •Patients who will not be extubated in the operating room after surgery.
研究组 & 干预措施
Group SB
Patients will receive a scalp block with bupivacaine alone.
干预措施: Scalp block (Other)
Group SD
Patients will receive a scalp block with dexmedetomidine as an adjuvant to bupivacaine.
干预措施: Scalp block + Dexmedetomidine (Other)
结局指标
主要结局
Cumulative postoperative morphine consumption
时间窗: 24 hours postoperatively
If the Visual Analogue Scale (VAS) score is ≥3, rescue analgesia will be administered; intravenous morphine will be given at a dose of 0.05 mg/kg
次要结局
- Time for 1st rescue analgesia(24 hours postoperatively)
- Incidence of complications(24 hours postoperatively)
- Heart rate(24 hours postoperatively)
- Mean arterial pressure(24 hours postoperatively)
- Degree of pain(24 hours postoperatively)
研究者
Omar Ahmed Zakaria Khiralla
Resident of Anaesthesia, Intensive Care Unit and Pain, Faculty of Medicine, Ain shams University, Cairo, Egypt.
Ain Shams University