Comparison of efficacy of intraperitoneal instillation of Ropivacaine with Dexmedetomidine vs Ropivacaine with Dexamethasone for pain relief after laparoscopic cholecystectomy; a prospective randomized, double blind study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To access the postoperative analgesia using NRS score in patients undergoing laparoscopic cholecystectomy using intraperitoneal instillation of ropivacaine and dexmedetomidine vs ropivacaine and dexamethasone
研究概览
简要总结
Laparoscopic cholecystectomy (LC) has rapidly become the procedure of choice for routine gallbladder removal and is currently the most commonly performed major abdominal procedure. The patient complains more of visceral pain after laparoscopic cholecystectomy in contrast to the parietal pain experienced in open cholecystectomy. Dissection around the gallbladder bed and capno-peritoneum raises the intraperitoneal pressure, which results in peritoneal inflammation. This leads to visceral abdominal pain that gets aggravated by coughing, deep breathing, and movement.
Various multimodal approaches have been tried to ameliorate post-operative pain, which includes parenteral opioids, NSAIDs, analgesic patches, steroids, and local infiltration of local anaesthetics alone or with additives. Intraperitoneal instillation of local anaesthetics (LA) block the visceral afferent signals and modify visceral nociception. However, as LAs are short-acting, adding adjuvants will prolong the duration of anaesthesia and enhance the analgesic effect.
All parenteral medications have associated adverse effects like respiratory depression, drug dependence or abuse, nausea, vomiting, CNS side effects, etc. Local anesthetics have the added advantage that they cause fewer systemic side effects. Adding adjuvants increases the duration of the postoperative analgesic effect. Dexamethasone is a strong, long-acting glucocorticoid that is effective in relieving postoperative pain as well as postoperative nausea in laparoscopic surgeries.
Dexmedetomidine is an alpha-2 adrenergic agonist. Studies have shown that topical application of dexmedetomidine during nerve block can enhance the analgesic effect, reduce the dosage of local anaesthetic and improve the postoperative analgesic effect. There are very few studies comparing the efficacy of dexamethasone vs dexmedetomidine as adjuvants in intraperitoneal installation, and hence the following study is being undertaken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 59.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA 1 and 2 patients Age:
- •59 years Patients undergoing elective laparoscopic cholecystectomy surgery Patients who are able to interpret Numerical rating scale scoring.
排除标准
- •Presence of acute cholecystitis, and choledocholithiasis.
- •Patients on steroids Pregnant and lactating women Patients who have undergone previous abdominal surgery.
- •Laparoscopy getting converted to open surgeries History of allergies to medications Patient on beta blockers Duration of surgery: more than 3 hours.
结局指标
主要结局
To access the postoperative analgesia using NRS score in patients undergoing laparoscopic cholecystectomy using intraperitoneal instillation of ropivacaine and dexmedetomidine vs ropivacaine and dexamethasone
时间窗: Using NRS, the post-operative pain intensity will be measured for each patient at rest and during movement at 20 mins, 30mins, 1 hour, 2, 4, 6, 12, and 24 hours from the time of extubation.
次要结局
- To assess the time required for the first rescue analgesia(And the total dose of rescue analgesia over 24 hours)
- To assess incidence of Postoperative nausea and vomiting and Sedation score(Patient will be assessed at 20, 30 mins, 1,2,4,6,12,24 hours)
研究者
Dr Johnson P Abraham
St Johns medical College Hospital, Bangalore