Comparative Evaluation of Dexamethasone as an adjuvant to 0.25 percent Ropivacaine vs 0.25 percent Ropivacaine with Normal Saline in External Oblique Intercostal Plane Block in patients undergoing Laparoscopic Cholecystectomy
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 24 hour tramadol consumption in mg
研究概览
简要总结
Pain following laparoscopic cholecystectomy is a common complaint that prolongs hospital stay and therefore increases morbidity. Most patients experience mild to moderate pain after laparoscopic cholecystectomy. External oblique intercostal plane block is a novel block, which has been described as an important modification of the fascial plane blocks that can consistently involve the upper lateral abdominal walls. Ropivacaine is a long acting local anaesthetic and has a documented better safety profile than other local anaesthetics. . Dexamethasone is a highly potent, long-acting glucocorticoid with analgesic, antiemetic, and anti-inflammatory properties, and when used as an adjuvant in peripheral nerve blocks, increases the duration of analgesia with minimal side effects and has an added advantage in decreasing postoperative nausea and vomiting. The proposed study aims to assess the efficacy of dexamethasone as an adjuvant to ropivacaine in comparison to plain ropivacaine on External oblique intercostal plane block in patients undergoing laparoscopic cholecystectomy as a part of multimodal analgesia. We hypothesize that the addition of dexamethasone 8 mg to ropivacaine 0.25 percent in External oblique intercostal plane block would prolong the analgesic effect and reduce 24hr tramadol consumption when compared with plain ropivacaine 0.25 percent in patients undergoing laparoscopic cholecystectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •With ASA physical status classification of I and II Scheduled to undergo elective laparoscopic cholecystectomy surgery.
排除标准
- •Patient refusal Coagulation disorders Liver or kidney disease Abdominal surgery history Infection in the block application area Chronic opioid use Local anaesthetic allergy Pregnancy or BMI less than 18 or more than 35 Diabetes Mellitus.
结局指标
主要结局
24 hour tramadol consumption in mg
时间窗: 15,30,60 mins | 2,6,12,24 hours
次要结局
- Sedation Score(15,30,60 mins)
- Post Operative Nausea and Vomiting Score(15,30,60 mins)
- Blood glucose levels 6hrs after block(6 hrs)
- Numerical Rating Scale(15,30,60 mins)
研究者
Dr Keerthana R
Ayushman Hospital and Health Services
