跳至主要内容
临床试验/CTRI/2023/08/056800
CTRI/2023/08/056800尚未招募Unknown

Compare the analgesic effect of dexmedetomidine and dexamethasone as an adjuvant to ropivacaine in ultrasound guided erector spinae plane block for laparoscopic cholecystectomy

Maulana Azad Medical College and associated Lok Nayak ,G.N.E.C.,G.I.P.M.E.R Hospitals,New Delhi1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年8月30日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Postoperative pain using NRS score at various time intervals in both groups.

研究概览

简要总结

We are comparing the analgesic effect of dexmedetomidine and dexamethasone as an  adjuvant to ropivacaine in ultrasound guided erector spinae plane block for laparoscopic cholecystectomy in patients between the age of 18 to 65 yrs. Erector spinae plane block will be given bilaterally before standard general anaesthesia induction to patients undergoing laparoscopic cholecystectomy .The aim of the study is to compare the analgesic effect of two groups .Two groups are   DX- 0.2% ropivacaine with dexamethasone(10mg) ,  DM - 0.2% ropivacaine with dexmedetomidine (0.5mcg/kg). patients will be assigned into two groups by randomisation using lottery method, into  groups DX and DM. Postoperative pain using  NRS score at various time intervals in both groups will be noted, also 1)The time at which the first rescue analgesia will be requested post operatively in both groups 2) Total amount of analgesic consumption within 24 hours postoperatively in both groups 3) Time of initiation of ambulation. 4) Respiratory Function(FEV1, FVC, FEV1/FVC and PEFR) pre-operatively and24hrspost-operatively using hand held spirometer. 5) Incidence of post operative nause and vomiting PONV6) Patient satisfaction will also be noted.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 18 to 65 years of age undergoing laparoscopic cholecystectomy 2)Patients of ASA I and II.

排除标准

  • Patient refusal.
  • Bleeding diathesis.
  • Local skin infection at the site of block.
  • Psychiatric disorder or risk of psychiatric disease.
  • Laparoscopic cholecystectomy turned to open cholecystectomy.
  • Any allergy to local anaesthetics or adjuvants dexmedetomedine/dexamethasone.

结局指标

主要结局

Postoperative pain using NRS score at various time intervals in both groups.

时间窗: 0 mins | 30 mins | 1 hours | 2 hours | 6 hours | 12 hours | 24hours

次要结局

  • 1)The time at which the first rescue analgesia will be requested post operatively in both groups(2) Total amount of analgesic consumption within 24 hours postoperatively in both groups)

研究者

发起方
Maulana Azad Medical College and associated Lok Nayak ,G.N.E.C.,G.I.P.M.E.R Hospitals,New Delhi
申办方类型
Government medical college

研究点 (1)

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