跳至主要内容
临床试验/CTRI/2020/10/028207
CTRI/2020/10/028207尚未招募不适用

A randomized controlled trial comparing the efficacy of Bupivacaine injection in vaginal vault and para-cervical region vs vaginal vault infiltration with Bupivacaine after Total Laparoscopic Hysterectomy.

All India Institute Of Medical Sciences1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年8月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Visual Analog Scale of pain

研究概览

简要总结

The study is a randomized , double blinded , two armed comparative trial comparing safety and efficacy of two methods - vault infiltration with Bupivacaine versus paracervical block and vault infiltration with Bupivacaine after total laparoscopic hysterectomy . 10 ml of 0.5 % Bupivacaine will be injected in vault to group I and both paracervical and vault infiltration of 10 ml 0.5% Bupivacaine each will be administered to group II after Total laparoscopic hysterectomy done for benign gynaecological conditions and their postoperative pain is measured at 1 , 2 and 6 hours by VAS score from the time of vault infiltration and compared .

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
25.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • 1.Benign Gynecological conditions.
  • 2.With or without salpingo oophorectomy.
  • 3.Consenting women.

排除标准

  • 1.Extensive additional tissue manipulation during surgery 2.Undue prolonged surgeries 3.Gynecological malignancies 4.Conversion to laparotomy 5.History of PID 6.Known allergy to amide anesthetics 7.Women not consenting to participate in the study.

结局指标

主要结局

Visual Analog Scale of pain

时间窗: 1 hour

次要结局

  • visual analog scale of pain(2 hours and 6 hours)

研究者

申办方类型
Government medical college

研究点 (1)

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