临床试验/CTRI/2024/07/070669

CTRI/2024/07/070669尚未招募4 期

Comparison of Erector Spinae Plane block with Intrathecal Morphine for post-operative analgesia in patients undergoing surgery for gynaecological malignancies.

Maulana Azad Medical College1 个研究点分布在 1 个国家目标入组 38 人开始时间: 2024年7月25日最近更新: 2024年7月9日

试验速览

阶段: 4 期
状态: 尚未招募
发起方: Maulana Azad Medical College
入组人数: 38
试验地点: 1
主要终点: Time to request for first rescue analgesia.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

We are comparing Erector Spinae Plane Block with Intrathecal morphine for post-operative analgesia in patients of age group 18-80 yrs undergoing surgery for gynaecological malignancy.The aim of the study is to compare Erector Spinae Plane Block with Intrathecal morphine for post-operative analgesia in patients undergoing surgery for gynaecological malignancy, taking a total sample size of 38, 19 patients in each group.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 18.00 Year(s) 至 80.00 Year(s)（—）
性别: Female

入选标准

•Patients of age 18-80 years
•Patients fulfilling American Society of Anesthesiologists (ASA) physical status I, II, III criteria.
•BMI: 18-35kg/m2 (body weight atleast 40 kg)
•Surgical approach via midline abdominal incision.

排除标准

•Known allergy to the drugs in the study
•Pregnancy
•Any contraindication to a regional/neuraxial local anesthetic, such as bleeding disorders or local infection
•History of chronic pain or patient on chronic pain medication
•Drug abuse.

结局指标

主要结局

Time to request for first rescue analgesia.

时间窗: 24 hours in the post-operative period

次要结局

1. Numerical Rating Scale at 2,4,6,12 and 24 hours postoperatively.(2. Total consumption of intravenous fentanyl intraoperatively.)

研究者

发起方

Maulana Azad Medical College

申办方类型

Government medical college

责任方

Principal Investigator

主要研究者

Aarushi Aggarwal

Maulana Azad Medical College

研究点 (1)

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