Intrathecal Dexmedetomidine-Fentanyl Combination Versus Fentanyl Alone as Adjuvant to Bupivacaine in Spinal Anesthesia for Above Knee Amputation in Sarcomas of Lower Extremity: A Randomized, Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Time to first rescue analgesia
研究概览
简要总结
The current work evaluated whether the combination of intrathecal dexmedetomidine and fentanyl provides superior postoperative analgesia to fentanyl alone when administered with hyperbaric bupivacaine.
详细描述
Above-knee amputation (AKA) for advanced lower limb (LL) sarcomas has a high risk of chronic pain syndromes, like phantom limb pain, and is associated with severe perioperative pain. Effective analgesia is essential for patient comfort, early rehabilitation, and improved outcomes.
Dexmedetomidine (DEX), a highly selective α2-adrenergic agonist, is a promising intrathecal (IT) adjuvant.
The combination of DEX and fentanyl may produce synergistic effects, extending block duration and improving perioperative analgesia while minimizing individual drug doses. The current approach is particularly relevant in oncologic surgeries like AKA, where optimal pain control is critical. However, supportive evidence exists in various surgical contexts.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 60 years.
- •Both sexes.
- •American Society of Anesthesiologists (ASA) physical status of II-III.
- •Height between 150-185 cm.
- •Body mass index between 18-35 kg/m².
- •Scheduled for above-knee amputation due to lower limb sarcomas.
排除标准
- •Allergy to any of the investigated drugs.
- •History of heart block, arrhythmia, or ongoing therapy with beta- or calcium channel- blockers, or angiotensin-converting-enzyme inhibitors.
- •Contraindications to spinal anesthesia.
- •Pregnancy or lactation.
- •Presence of psychiatric illness or chronic pain conditions.
研究组 & 干预措施
Group DF
Patients will receive 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl + 5 µg dexmedetomidine.
干预措施: Fentanyl + Dexmedetomidine (Drug)
Group F
Patients will receive 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl.
干预措施: Fentanyl (Drug)
结局指标
主要结局
Time to first rescue analgesia
时间窗: 24 hours postoperatively
Time to first rescue analgesia (time from the end of surgery till the first dose of morphine is administered).
次要结局
- Intraoperative fentanyl consumption(Intraoperatively)
- Degree of pain(24 hours postoperatively)
- Incidence of adverse events(24 hours postoperatively)
- Total amount of morphine(24 hours postoperatively)
研究者
Mai Mohamed El Rawas
Assistant professor of Anaesthesia, Intensive Care and Pain Management, National Cancer Institute, Cairo University Cairo University, Cairo, Egypt.
National Cancer Institute, Egypt