跳至主要内容
临床试验/CTRI/2021/12/038916
CTRI/2021/12/038916招募中2 期

Magnesium sulphate as adjuvant to ropivacaine in bilateral transversus abdominis plane block for laproscopic cholecystectomy.

Govt SKIMS Medical College Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年1月1日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
The post-operative pain during first 24 hours after surgery using Visual analogue scale.

研究概览

简要总结

The study is a prospective randomised controlled trial to assess the effect  of adding magnesium sulphate  as adjuvant to ropivacaine in ultrasound guided transversus abdominis plane block in laproscopic cholecystectomy.The study is planned for 80 patients.The primary outcome measure is post-operative pain during the first 24 hours after surgery using visual analogue scale.Secondary outcome measures are time to first dose of post-operative analgesia and total diclofenac consumption in 24 hours, post-operative nausea and vomiting,sedation,patient satisfaction.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator 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

  • Adult patients aged 18-65 years undergoing laparoscopic cholecystectomy.

排除标准

  • 1.Patient refusal 2.Patients with a history of cardiac, or respiratory diseases (>ASA III).
  • 3.Patients with allergy to amide local anesthetics or medication included in the study.
  • 4.Infection at the needle insertion site.
  • 5.Pregnancy 6.BMI >35 7.Drug abusers.

结局指标

主要结局

The post-operative pain during first 24 hours after surgery using Visual analogue scale.

时间窗: 24 hours

次要结局

  • 1.Time to first dose of post-operative analgesia and total diclofenac consumption in 24 hours(2.Post-operative nausea and vomiting)

研究者

发起方
Govt SKIMS Medical College Hospital
申办方类型
Government medical college

研究点 (1)

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