跳至主要内容
临床试验/CTRI/2025/03/081732
CTRI/2025/03/081732尚未招募Phase 3 4

A Prospective randomized study to evaluate efficacy of Serratus Anterior Plane block in addition to multimodal analgesia for perioperative opioid sparing in patients undergoing modified radical mastectomy

Nizams Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月17日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
入组人数
60
试验地点
1
主要终点
compare postoperative opioid consumption requirement between the groups

研究概览

简要总结

Introduction:

Despite the implementation of novel surgical techniques and multimodal analgesia regimens,nearly 60% of breast surgery patients experience severe acute postoperative pain(1).

A poorly controlled perioperative pain management strategy on this surgical population, may result in delayed functional recovery, delayed post anesthesia care unit (PACU) discharge and/or extended length of hospital stay .In addition, inadequate postoperative pain management is recognized as one of the most relevant risk factors for the development of chronic postoperative breast pain(2). Serratus Anterior Plane (SAP)  block is a safe and effective method to treat postoperative pain after breast surgery(3). It  primarily targets the thoracic intercostal nerves (T2-T8), providing complete analgesia to the antero- lateral part of the thorax.There are few publications evaluating its effectiveness in conjunction with multimodal analgesia (MMA) in pain management and opioid sparing effect after modified radical mastectomy (MRM). Multimodal analgesia (MMA) is a strategy that aims to reduce reliance on opioids, and involves the use of two or more drugs that have different mechanisms of action to provide adequate analgesia. In the recent times there has been an increasing emphasis on use of multimodal analgesia (MMA), particularly in the context of postoperative enhance recovery after surgery (ERAS) protocols, reducing perioperative opioid consumption and, subsequently, their side effects(4). The use of oral gabapentinoids and acetaminophen alone or in conjunction with regional anesthesia as part of multimodal analgesia(MMA), has shown an adequate reduction on pain scores and opioid consumption(5). Therefore, our study hypothesized that the use of a serratus anterior plane (SAP) block in combination with multimodal analgesia (MMA) will reduce perioperative opioid consumption in patients undergoing modified radical mastectomy ( MRM).

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • ASA 1 & 2 Patients with carcinoma breast posted for modified radical mastectomy.

排除标准

  • ASA 3 and above patients, denial of consent for the procedure, previous allergic history to anaesthetic drugs, coagulopathy, patients with fungating breast malignancy with distant metastasis, patients on anticoagulation, pregnant women, gross abnormality in the anatomy of chest wall due to malignancy, severe cardiac, respiratory and neurological dysfunction.

结局指标

主要结局

compare postoperative opioid consumption requirement between the groups

时间窗: at 1hr, 2hr, 6hr, 12hr, 24hr after surgery.

次要结局

  • incidence of postoperative nausea and vomiting(PONV), time to first opioid demand, functional activity score at rest and on arm abduction.(at 1hr, 2hr, 6hr, 12hr, 24hr after surgery.)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Srikanth Kakunoor

Nizams Institute of Medical Sciences

研究点 (1)

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