A comparative study of impact on Post-operative analgesia with intraperitoneal irrigation of high volume low concentration bupivacaine plus hydrocortisone vs bupivacaine alone in patients undergoing elective cholecystectomy.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Time to first rescue analgesic
研究概览
简要总结
Laparoscopic cholecystectomy has become a preferred modality of treatment in gall bladder surgeries. It is the gold standard for the treatment of symptomatic cholelithiasis and chronic cholecystitis. Pain is a frequent complaint following laparoscopic cholecystectomy(LC). Pain in LC can be divided into components such as parietal ,viscera and shoulder pain.Visceral pain accounts for most of the discomfort experienced in the early post operative period.Intensity quickly decreases after the first 24hrs post operatively.Shoulder tip pain dominates as visceral pain decreases. The surgical stress and insufflation of abdomen with CO2 causing rapid distention of the peritoneum may result in tearing of blood vessels ,traumatic traction of the nerves and release of inflammator meiators causing pain.Pneumoperitoneum with CO2 is thought to cause phrenic nerve irritation secondarily causing referred shoulder tip pain. Various drugs and methods have been studied to effectively counter these undesirable effect . Local anaesthetics have been observed to be effective in providing post operative analgesia in patients undergoing laparoscopic cholecystectomy .Some studies have observed that intraperitoneal Bupivacaine does not reduce pain after laparoscopic cholecystectomy , but these studies used high concentration low volume bupivacaine intraperitoneally. It has been demonstrated that use of bupivacaine as low concentration high volume intraperitoneal irrigation,intraoperatively is effective in prolonging the duration of analgesia reduces post operative rescue analgesic requirement in the initial 24 hr without significant postoperative adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients who are willing to give written informed consent.
- •Patients with ASA Grade 1 and
- •Patients scheduled for elective laparoscopic cholecystectomy.
排除标准
- •PATIENT REFUSAL
- •ALLERGY TO LOCAL ANESTHETIC DRUGS
- •PATIENTS WITH ACUTE PANCREATITIS,CHRONIC PAIN, CHOLEDOCHOLITHIASIS
- •PATIENTS WITH CHRONIC OPIOID USE, CHRONIC NSAID USE
- •INABILITY TO COMPREHEND VAS
- •PATIENTS WITH CONVERSION OF LAPAROSCOPIC CHOLECYSTECTOMY TO OPEN CHOLECYSTECTOMY.
结局指标
主要结局
Time to first rescue analgesic
时间窗: Time to first rescue analgesic
次要结局
- Total rescue analgesic requirement(first 24 hours)
- Time to Ambulation(First 24 hours)
- Total episodes of vomiting(first 24 hours)
- incidence of shoulder pain(first 48 hours)
