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临床试验/CTRI/2025/08/093706
CTRI/2025/08/093706尚未招募2/3 期

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

未提供1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月5日最近更新:

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

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Keerthana R

Ayushman Hospital and Health Services

研究点 (1)

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