Comparison of Intra-Peritoneal Instillation of Levobupivacaine With Morphine Hydrochloride Versus Levobupivacaine With Magnesium Sulfate for Post-Operative Pain Relief After Laparoscopic Cholecystectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- reduction of postoperative pain
研究概览
简要总结
This is a prospective randomized study that included 60 patients and was divided into two equal groups of patients who were scheduled for LC, Ages 18 and 60 years, both sexes, ASA I-II and BMI 19 - 39. Group A received 30 ml levobupivacaine (0.25%) plus 3 mg morphine intraperitoneal at the site of surgery in the bed of the gallbladder via the navel port with the patient in a Trendelenburg position, Group B received 30 ml levobupivacaine (0.25%) plus 50 mg/kg magnesium sulfate in the same pattern as in the A group.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Patients who were scheduled for L.C,
- •Ages 18 and 60 years
- •ASA I-II and
- •BMI 19 - 39
排除标准
- •Patients with hepatic or renal dysfunction
- •use of opioids 24 hrs prior to the study
- •treatment with steroids prior to surgery
- •drug or alcohol abuse, allergy to any of the study drugs
- •chronic pain syndrome as a result of neurological disease
研究组 & 干预措施
levobupivacaine with morphine
30 patients will have intraperitoneal instillation of levobupivacaine with added morphine at the end of laparoscopic cholecystectomy operation
干预措施: intraperitoneal levobupivacaine and morphine (Drug)
levobupivacaine with magnesium sulfate
30 patients will have intraperitoneal instillation of levobupivacaine with added magnesium sulfate at the end of laparoscopic cholecystectomy operation
干预措施: intraperitoneal levobupivacaine and morphine (Drug)
结局指标
主要结局
reduction of postoperative pain
时间窗: 8 hours
reduction of post operative visual analogue score
次要结局
未报告次要终点
研究者
Islam Mokhtar Ahmed
lecturer of anesthesia and intensive care
Sohag University