Comparative Study Between Transdermal Fentanyl and Melatonin Patches on Postoperative Pain Relief After Lumber Laminectomy, a Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 主要终点
- A mean difference of total analgesic (pethidine) consumption.
研究概览
简要总结
Seventy five patients, aged 18-50 years, ASA I and II undergoing elective single level lumber laminectomy under general anesthesia were included in this randomized controlled double-blind study. Patients were randomly divided into 3 groups 25 each, C group patients received transdermal placebo patch, TDF group (50μg/h) and TDM group (7 mg). Assessment of postoperative pain, sedation, hemodynamic variables such as HR and MAP, postoperative monitoring of arterial SpO2 and side effects (e.g. nausea, vomiting, pruritis, respiratory depression and hemodynamic instability) were done 30 minutes, 1, 2, 6 and 12 hours postoperatively. Postoperative Patient's and Surgeons' satisfaction, Intraoperative bleeding and plasma cortisol (µg / dl) postoperatively were also assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •75 patients aged between 18 and 50 years old
- •Both sex of ASA physical status I and II
- •70-90 kg body weight
- •Height 160-180 cm
- •Undergoing elective single level lumber laminectomy under general anesthesia.
排除标准
- •Patients with impaired kidney or liver functions
- •History of cardiac or central nervous system disease
- •History of drug or alcohol abuse
- •History of chronic pain or daily intake of analgesics
- •Uncontrolled medical disease (diabetes mellitus and hypertension)
- •History of intake of non-steroidal anti-inflammatory drugs or opioids within 24 h before surgery or allergy to the used medications
- •Coagulation defect
- •Local infection at the site of application of transdermal patch
- •Patient refusal or duration of surgery more than 120 minutes were excluded from the study.
研究组 & 干预措施
C group, (n=25)
C group, (n=25) each patient received transdermal placebo patch
干预措施: Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomy (Drug)
TDF group, (n=25)
TDF group, (n=25) each patient received transdermal therapeutic system-fentanyl 50μg/h
干预措施: Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomy (Drug)
TDM group, (n=25)
TDM group, (n=25) each patient received transdermal therapeutic system containing 7 mg of melatonin
干预措施: Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomy (Drug)
结局指标
主要结局
A mean difference of total analgesic (pethidine) consumption.
时间窗: The total pethidine requirements (mg) 12 hours postop
次要结局
未报告次要终点
研究者
Dr.Ibrahim Mamdouh Esmat
Dr.Ibrahim Mamdouh Esmat
Ain Shams University