跳至主要内容
临床试验/CTRI/2024/02/062869
CTRI/2024/02/062869尚未招募4 期

Comparison of analgesic efficacy of Erector Spinae Plane Block with combined Rhomboid Intercostal and Subserratus Plane Block in patients undergoing modified radical mastectomy: a randomized control trial.

All India Institute of Medical Sciences,Patna1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年3月1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
40
试验地点
1
主要终点
To compare the requirement of postoperative opioid consumption

研究概览

简要总结

Modified radical mastectomy (MRM) is the most common surgery for breast cancer that is associated with marked postoperative pain. Ultrasound guided fascial plane blocks have been rapidly incorporated into regional anesthesia practice. Fascial plane blocks are emerging to provide feasible, safe alternatives comparing to epidural analgesia for management of pain. The ultrasound guided rhomboid intercostal block combined with the subserratus plane block (RISS) is a novel analgesic technique recently described by Elsharkawy et al. There are only few case reports, RCT’s and observational studies carried out to study the efficacy of this block. We propose to conduct this randomized clinical trial to compare the analgesic efficacy of Erector spinae plane block with combined Rhomboid intercostal and sub serratus plane block in patient undergoing modified radical mastectomy.

 Problem statement- MRM surgery involves extensive dissection results in severe pain and can lead to significant halted postoperative recovery if pain isn’t managed appropriately. Opioids are considered to be the mainstay for perioperative pain management, however its usage is associated with adverse effects like respiratory depression, postoperative nausea vomiting. Current practice includes performance of fascial plane blocks including PEC block, Paravertebral block, Erector spinae plane block.

 Rationale – Peripheral nerve blocks are known to be effective for pain management during and after surgeries. The ultrasound guided Rhomboid Intercostal block combined with the Subserratus plane block (RISS) and Erector Spinae plane block (ESP) are safe and effective technique for multimodal pain management during perioperative period. Regional anaesthesia techniques, including ESP and RISS, provide targeted and prolonged analgesia while minimizing systemic opioid consumption. These techniques offer the advantage of reduced opioid-related side effects.Both techniques are the newer for postoperative pain management.

 Novelty- There are only few case reports, RCT’s and observational studies carried out to study the efficacy of this block. There is no RCT Comparing the analgesic efficacy of Erector Spinae Plane Block with combined Rhomboid Intercostal and Subserratus Plane Block in patients undergoing modified radical mastectomy.

 **Expected outcome and application –**Analyze the analgesic efficacy of Erector Spinae Plane Block with combined Rhomboid Intercostal and Subserratus Plane Block in patients undergoing modified radical mastectomy.Reduced opioid consumption and better pain scores in adult patients undergoing modified radical mastectomy. This will facilitate to include this block as a part of multimodal analgesic regimen in routine practice in our set up in this subset of patients.

 Research question(s) - Is ultrasound guided Rhomboid Intercostal combined with Subserratus plane Block (RISS) better analgesic technique than Erector Spinae Plane block with less adverse effects in patients undergoing modified radical mastectomy (MRM)?

 Research hypothesis (es): We hypothesize that the analgesic efficacy of Rhomboid Intercostal combined with Subserratus plane Block (RISS) would be better than Erector Spinae Plane (ESP) for patients undergoing MRM surgery.

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 65.00 Year(s)(—)
性别
All

入选标准

  • Patients willing to give written informed consent
  • Aged 18-65 years
  • ASA I –II patients scheduled to undergo elective MRM surgery under GA.

排除标准

  • 未提供

结局指标

主要结局

To compare the requirement of postoperative opioid consumption

时间窗: To compare the requirement of postoperative opioid consumption

次要结局

  • 1.Intraoperative opioid consumption(2.To determine time of first rescue analgesic administration)

研究者

发起方
All India Institute of Medical Sciences,Patna
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Poonam Kumari

All India Institute of Medical Sciences,Patna

研究点 (1)

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