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临床试验/CTRI/2025/08/092730
CTRI/2025/08/092730尚未招募4 期

Comparative study of Thoracic Segmental Spinal Anesthesia and Erector Spinae Plane Block for modified radical mastectomy: A randomized controlled clinical trial

Institute of medical sciences and sum hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年8月26日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
Comparison of postoperative pain scores (VAS) between Group TSSA and Group ESPB.

研究概览

简要总结

This prospective randomized controlled trial compares thoracic segmental spinal anesthesia (TSSA) with erector spinae plane block (ESPB) for postoperative analgesia in patients undergoing modified radical mastectomy. Ninety ASA I and II patients aged above 18 years will be randomized into two groups: Group TSSA receiving 1.5 ml of 0.2% isobaric ropivacaine with 5 mcg dexmedetomidine at T4–T5 interspace, and Group ESPB receiving 20 ml of 0.2% ropivacaine with 0.5 mcg/kg dexmedetomidine at T5 level under ultrasound guidance. Primary outcome is postoperative pain scores measured by VAS at 30 minutes and 2 hours. Secondary outcomes include time to first analgesia, rescue analgesic requirements, and incidence of complications. Randomization uses computer-generated numbers with sealed opaque envelope concealment; outcome assessor will be blinded. Statistical analysis includes Mann-Whitney U test, unpaired t-test, and Chi-square test. The study aims to evaluate which regional technique provides superior postoperative analgesia in breast cancer surgeries.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
Female

入选标准

  • Patients willing to participate with written informed consent.
  • ASA grade I and II.
  • Patients age more than 18 years.
  • Patients undergoing modified radical mastectomy.

排除标准

  • ASA grade more than II.
  • Thrombocytopenia or coagulopathy.
  • Local site infection.
  • Spinal or chest deformity.
  • Surgery duration expected to exceed 3 hours.

结局指标

主要结局

Comparison of postoperative pain scores (VAS) between Group TSSA and Group ESPB.

时间窗: after 30 minutes and 2 hours post extubation

次要结局

  • Incidence of adverse events (hypotension, bradycardia, nausea, vomiting, block-related complications).(at 12 hours post operatively & at 24 hours postoperatively)

研究者

发起方
Institute of medical sciences and sum hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Nunna Mounika

Institute of medical sciences and sum hospital, Siksha O anusandhan

研究点 (1)

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