The Evaluation of the Analgesic Effect of Intraperitoneal Bupivacaine Versus Bupivacaine With Neostigmine on Postoperative Pain in Laparoscopic Cholecystectomy:A Prospective, Randomized, Comparative, Double-blind Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Time of first analgesic requirements (in hours) after extubation
研究概览
简要总结
Injection of intraperitoneal bupivacaine revealed an analgesic effect whether injected alone or in combination with other adjuvants, which increase duration of analgesia and decrease the dose of administered bupivacaine thus minimizing its side effects e.g. Opioids, Corticosteroids and Magnesium sulphate.
Neostigmine, a cholinesterase inhibitor that produces muscarinic receptor-mediated analgesia, increased postoperative analgesia when combined with local anaesthetics. Peripheral afferent nerve fibres contain muscarinic receptors, these could be a good target for pain suppression.
详细描述
The use of neostigmine as adjuvant to intraperitoneal bupivacaine was not previously investigated. In this study the investigators will compare the analgesic effect of bupivacaine alone and bupivacaine in combination with neostigmine when injected intraperitoneal in patients undergoing laparoscopic cholecystectomy.
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
- Single (Care Provider)
盲法说明
Patients will be randomly allocated to one of two groups with the help of computer generated random number tables in opaque sealed envelopes prepared by an anaesthesiologist not part of the study. The envelops will be opened by the staff nurse, and peritoneal solution will be prepared according to group allocation by anaesthesiologist who is not involved in the study.
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
- •• American Society of Anaesthesiologist (ASA) I-II.
- •Age 18 - 60 years.
- •Elective laparoscopic cholecystectomy.
- •Body Mass Index (BMI) <35 (kg/m2).
排除标准
- •• Anaphylaxis to local anaesthetics.
- •Anaphylaxis to Neostigmine.
- •American Society of Anaesthesiologist (ASA) III-IV.
- •Chronic pain diseases.
- •Acute cholecystitis.
- •Psychological or nervous system diseases
研究组 & 干预措施
B group
-Group 1 (Bupivacaine group= B group) will receive a 50 mL solution of bupivacaine 0.25% intraperitoneal instilled solution.
干预措施: Bupivacaine Hydrochloride (Drug)
BN group
Group 2 (Bupivacaine neostigmine group=BN group) will receive 500 μg neostigmine mixed with bupivacaine 0.25% with a total volume of 50 mL intraperitoneal instilled solution.
干预措施: Bupivacaine Hydrochloride (Drug)
BN group
Group 2 (Bupivacaine neostigmine group=BN group) will receive 500 μg neostigmine mixed with bupivacaine 0.25% with a total volume of 50 mL intraperitoneal instilled solution.
干预措施: Neostigmine (Drug)
结局指标
主要结局
Time of first analgesic requirements (in hours) after extubation
时间窗: 24 Hours post-operatively.
hours
次要结局
- • Total dose of intravenous pethidine (mg/24 hours).(24 hours)
- • The use of intra-operative rescue analgesia.(intraoperative period)
- • The severity of post-operative shoulder pain assessed by visual analogue scale(24 Hours post-operatively.)
- • The severity of post-operative abdominal pain assessed by visual analogue scale(24 hours posoperatively)
- • Post-operative nausea and vomiting assessed by postoperative nausea and vomiting score(24 hours postoperatively)
研究者
Sara Farouk Kassem Habib
lecturer of anesthesiology
Kasr El Aini Hospital