Comparison of Intraperitoneal Instillation of Bupivacaine with Dexmedetomidine Versus Bupivacaine with Dexamethasone on Postoperative Pain After Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- incidence and severity of postoperative pain for 24 hours
研究概览
简要总结
Comparison of intraperitoneal instillation of bupivacaine with dexmedetomidine versus bupivacaine with dexamethasone on postoperative pain after laparoscopic cholecystectomy
详细描述
Laparoscopy has become the preferred mode for many diagnostic and operative procedures. It has the advantage better cosmetic results, faster recovery, short post-operative hospital stays, and early resumption of normal activities. Post-laparoscopic pain results from stretching of the intra-abdominal cavity, peritoneal inflammation, and diaphragmatic irritation caused by residual carbon-dioxide in the peritoneal cavity is very annoying to the patients.
Although the severity of pain after a laparoscopic procedure is less compared to laparotomy, but it is acute and can lead to increased analgesic requirements and prolonged hospital stays.
Several studies have evaluated post-laparoscopic pain relief methods such as intravenous analgesics analgesic patches, steroids, and intra-peritoneal instillation of local anaesthetics alone or with additives.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for laparoscopic cholecystectomy
- •Age 18-60 years
- •American Society of Anesthesiologists (ASA) physical status I-II
排除标准
- •Patients with diabetes mellitus
- •Allergy to the study drugs
- •Patients on steroids
- •Pregnant females
- •Patients with cardiac, pulmonary, hepatic or renal disorders
研究组 & 干预措施
bupivacaine with dexmedetomidine
40 mL of 0.25% bupivacaine + dexmedetomidine 1 μg/kg with normal saline 5 ml).
干预措施: bupivacaine with dexmedetomidine (Combination Product)
bupivacaine with dexamethasone
40 mL of 0.25% bupivacaine + 16 mg dexamethasone with 5 ml normal saline).
干预措施: bupivacaine with dexamethasone (Combination Product)
结局指标
主要结局
incidence and severity of postoperative pain for 24 hours
时间窗: severity of postoperative pain measured at 1, 2, 4, 8, 16, and 24 hours. postoperatively, using Visual Analogue Scale
using VAS pain score
次要结局
未报告次要终点
研究者
Zaher Zaki Zaher
Lecturer
Aswan University Hospital
