Comparison of effects of intraperitoneal dexamethasone with fentanyl as an adjuvant to ropivacaine in post operative analgesia for laparoscopic cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- To compare the postoperative analgesia by assessing pain score(NRS)
研究概览
简要总结
After approval from the institutional ethics committee, Patients satisfying the inclusion criteria will be enrolled after obtaining informed written consent. During pre-anaesthetic evaluation on the day before surgery, Premedication with tablet diazepam 5mg for <50 kg body weight and 10mg for >50 kg body weight and pantoprazole 40 mg night before and in the morning on the day of surgery will be prescribed as per routine institutional protocol. Numerical Rating Scale ( NRS) will be explained to the patient during preoperative evaluation. Once the patient is shifted to the operation theatre, standard monitoring with ECG, SpO2, NIBP and EtC02 will be done. Fluid will be started after securing a suitable intravenous cannula. Induction and maintenance of anaesthesia will be done according to the standard institutional anaesthesia protocol and a nasogastric tube of appropriate size will be inserted. As per the institutional protocol, Analgesic solution containing local anaesthetic with adjuvant will be administered intraperitoneally in Trendelenberg’s position after the removal of the gallbladder and before the removal of the trocar. The solution will be instilled by operating surgeon through trocar, as per discretion of the concerned anaesthesists into the hepato-diaphragmatic area, on the gall bladder bed, close to and above the hepatoduodenal ligament. The extubation will be carried out after adequate reversal of neuromuscular blockade, in accordance with institutional standard anaesthesia protocol. The patient will be shifted to the post anesthesia care unit (PACU) after the removal of the nasogastric tube. The degree of postoperative pain will be assessed using the Numerical Rating Scale at 30 minutes, 1 hour, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours postoperatively. When patient complains of pain or NRS score 4 and above, diclofenac aqueous 75 mg infusion will be given as rescue analgesic. Time to 1st rescue analgesic and 24 hours post operative analgesic requirement will be noted. If patient complains of nausea and vomiting, injection Ondansetron 4mg will be given intravenously and incidence of PONV will be doccumented. Any adverse effects in postoperative period will be treated accordingly and doccumented.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 16.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •ASA Grade I and II
- •Patients undergoing elective laparoscopic cholecystectomy.
排除标准
- •Patient refusal to participate in the study
- •Patients with known allergy to study drugs
- •Pregnant and lactating ladies
- •Uncontrolled hypertension and diabetes
- •Surgeries converted into open cholecystectomy
- •Known case of chronic abdominal pain due to other causes.
结局指标
主要结局
To compare the postoperative analgesia by assessing pain score(NRS)
时间窗: 24 hours after shifting to post operative ward
次要结局
- 1. Time to first request of rescue analgesia(2. 24 hour Post operative analgesic requirement)
