Efficacy of Coadministration of Calcitonin and Hyperbaric Bupivacaine in Spinal Anesthesia in Lower Abdominal and Limb Surgeries in Tramadol-abuse Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The total dose of rescue analgesia (mg)
研究概览
简要总结
Increasing duration of local anesthetic action is desired for prolongation of postoperative patient comfort, as well as decreasing perioperative opioid consumption and subsequent side effects. Calcitonin, discovered in 1961, has been established, synthesized, and developed for use in treating disease. In 1983 it was demonstrated that calcitonin is an analgesic, which is also effective in the epidural and subarachnoid spaces.Tramadol abuse has dramatically increased in Egypt since 2008 and has led to many admissions to addiction treatment centers.It was shown that the duration of sensory block of spinal anesthesia with hyperbaric bupivacaine in chronic opium abusers undergoing lower extremity orthopedic surgery was much shorter in chronic opium abusers compared with non-abusers.
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, Investigator)
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
- •Patients with history of tramadol addiction (single drug addiction) and duration of addiction >1 year
- •Elective lower abdomen or lower extremities surgeries under spinal anesthesia
- •ASA physical status I and II
排除标准
- •Patient's refusal,
- •duration of surgery more than 120 min,
- •obesity with body mass index (BMI) >35 kg/m2,
- •generalized infection or localized infection at level of blockade,
- •neurological disease,
- •psychological disorder
- •coagulation disorder,
- •history of uncontrolled hypertension,
- •history of uncontrolled blood sugar,
- •allergy to bupivacaine or calcitonin
研究组 & 干预措施
Group 1
injection of 15 mg (3 ml) hyperbaric bupivacaine 0.5% and 100 IU salmon calcitonin(1ml) intrathecally and injection of 10 ml normal saline (NS) slowly intravenously (IV) over 5 min.
干预措施: Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intrathecally (Drug)
Group 2
injection of 15 mg (3 ml) hyperbaric bupivacaine 0.5% and 1ml NS intrathecally and injection of 100 IU salmon calcitonin (1ml) diluted in 9 ml NS slowly IV over 5 min.
干预措施: Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intravenously (Drug)
Group 3 (control group)
injection of 15 mg (3 ml) hyperbaric bupivacaine 0.5% and 1ml NS intrathecally and injection of 10 ml NS slowly IV over 5 min.
干预措施: Normal Saline (NS) (Other)
结局指标
主要结局
The total dose of rescue analgesia (mg)
时间窗: The first 24 hours after surgery
The total dose of rescue analgesia (mg)
次要结局
未报告次要终点
研究者
Ibrahim Mamdouh Esmat
Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.
Ain Shams University