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临床试验/CTRI/2025/08/092613
CTRI/2025/08/092613尚未招募不适用

Comparative evaluation of ultrasound guided thoracic paravertebral block and modified pectoral nerve block for postoperative analgesia and stress response in patients undergoing modified radical mastectomy.

Maulana Azad Medical College and associated Lok Nayak Hospital1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年8月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
32
试验地点
1
主要终点
Time to request for 1st supplemental

研究概览

简要总结

We are comparing Thoracic Paravertebral Block with Modified Pectoral Nerve Block for post operative analgesia and stress response in patients posted for Modified Radical Mastectomy in Lok Nayak Hospital Delhi. A total of 32 patients with 16 patients in each group will be enrolled for the study. Patients will be explained about the study and written informed consent will be taken. A Preoperative blood sample (total of 3ml) will be taken for analyzing serum cortisol,Neutrophil Lymphocyte ratio and Interleukin-6 blood levels. We will be using standard general anaesthesia for induction of patients following which USG guided block site will be identified and local anesthetic drug will be administered. Patients will be followed up post operatively for 24 hours during which numerical rating scale for pain, time for first supplemental analgesia and total amount of analgesic consumption will be determined. Another blood sample(total of 3ml) will be taken 6 hours post surgery for analyzing serum cortisol, Neutrophil Lymphocyte ratio andInterleukin-6 blood levels. Overall patient satisfaction score will also be assessed.

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 65.00 Year(s)(—)
性别
Female

入选标准

  • 1.18 to 65 years of age 2.American Society of Anesthesiologists Physical Status I or II.

排除标准

  • 1.History of Neuropsychiatric Disorders 2.Infection at local site 3.Coagulopathies and Thrombocytopenia(platelet count less than 1 lacs) 4.BMI more than 30kg/m2 5.On chronic treatment with opioids 6.Pregnancy.

结局指标

主要结局

Time to request for 1st supplemental

时间窗: In postoperative period at 0 minutes,30 minutes,2 hours,4 hours,6 hours,12 hours and 24 hours

analgesic requirement post-operatively

时间窗: In postoperative period at 0 minutes,30 minutes,2 hours,4 hours,6 hours,12 hours and 24 hours

次要结局

  • 1.Hemodynamic changes(Heart Rate and Mean Arterial Pressure)will be(monitored and recorded before induction(baseline),after induction, post block, at skin incision and for every 15 minutes intra-operatively)

研究者

发起方
Maulana Azad Medical College and associated Lok Nayak Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Pinki

Maulana Azad Medical College

研究点 (1)

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