跳至主要内容
临床试验/CTRI/2025/09/095019
CTRI/2025/09/095019尚未招募不适用

EFFICACY OF ERECTOR SPINAE PLANE BLOCK USING ROPIVACAINE-DEXMEDETOMIDINE COMBINATION VERSUS ROPIVACAINE ALONE IN ADULT FEMALES UNDERGOING BREAST ONCOSURGERY –A RANDOMIZED CONTROLLED TRIAL

Sir Ganga Ram Hospital, New Delhi1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年10月1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
70
试验地点
1
主要终点
Post-operative pain assessed using VAS score

研究概览

简要总结

Breast cancer is the most commonly diagnosed cancer in women in India as per the National Cancer Registry Programme (NCRP) 2020 report by the Indian Council of Medical Research making Modified Radical Mastectomy (MRM) and flap reconstruction, the most commonly performed surgeries. MRM is usually done under general anesthesia (GA) using intravenous opioids but the incidence of moderate to severe postoperative pain after mastectomy under GA is high. ESP (Erector Spinae Plane) block in breast surgeries has been found to effectively reduce post operative pain and opioid consumption. Bupivacaine, a long-acting amide local anaesthetic, has been widely utilized in ESP blocks, demonstrating consistently favourable outcomes in terms of pain control and opioid-sparing effects. Ropivacaine, a long-acting amide local anaesthetic is an alternative to Bupivacaine and has superior cardiovascular safety profile with comparable analgesic efficacy. Structurally similar to Bupivacaine but less lipophilic, Ropivacaine has a lower propensity for central nervous system and cardiac toxicity, making it particularly suitable for patients with cardiovascular risk factors. Duration of analgesia with Ropivacaine alone is around 10-12 hours, Dexmedetomidine acts synergistically with LA (Local Anaesthetics) by prolonging the duration of sensory blockade, reducing nociceptive transmission, and attenuating central sensitization. Its analgesic properties contribute to reduced opioid requirements and improved patient comfort without significant respiratory depression.

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

  • 18-65 years
  • ASA physical status I, II, III.

排除标准

  • Anomalies of vertebral column
  • Any lesion obscuring Sono anatomy of injection site
  • History of allergy to study drugs
  • Patient not consenting to participate in the study.

结局指标

主要结局

Post-operative pain assessed using VAS score

时间窗: Postoperatively at 30 mins, 2 hr, 4 hr, 6 hr,12 hr,24 hr

次要结局

  • 1. Total rescue analgesics dose requirements(2. Post-operative nausea and vomiting)

研究者

发起方
Sir Ganga Ram Hospital, New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Anjali Gera

Sir Ganga Ram Hospital, New Delhi

研究点 (1)

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