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临床试验/CTRI/2025/06/088658
CTRI/2025/06/088658尚未招募不适用

Analgesic Efficacy of Serratus posterior superior intercostal plane block (SPSIPB) in breast surgeries: A randomised controlled trial

AIIMS New Delhi1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2025年1月8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
92
试验地点
1
主要终点
Postoperative fentanyl consumption using Patient controlled analgesia (PCA) pump

研究概览

简要总结

Effective postoperative analgesia management using regional anaesthesia technique is found to be standard of care in improving quality of care following breast surgery. Regional anesthesia is transforming postoperative care in breast surgery–providing effective pain relief while significantly reducing opioid use and its associated side effects like nausea and vomiting.

Traditionally, thoracic epidural and paravertebral blocks were used for postoperative analgesia following breast surgery However,due to their invasive nature and higher risk of complications, anesthesiologists now increasingly favor ultrasound guided interfascial plane blocks as safer and more precise alternatives.

Recently, a novel block called serratus posterior superior intercostal plane block (SPSIP) was described.  Preliminary case reports suggest that it offers effective pain relief, with reduced opioid requirements in procedures such as mastectomies with axillary lymph node dissection.Based on the current evidence and clinical observations, the SPSIP block appears to be a promising technique for reducing perioperative and postoperative opioid consumption in patients undergoing breast surgery.

This study aims to compare the efficacy of SPSIP block in the context of breast surgeries, focusing on their impact on postoperative pain management, opioid consumption, and patient outcomes. By comparing this to a control group, we aim to assess this novel interfascial plane block technique in breast surgeries.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
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
Female

入选标准

  • Patients undergoing unilateral breast surgery 2.

排除标准

  • Unwilling to participate
  • Local or systemic infection
  • Known allergy to study drugs
  • Known coagulopathy
  • Patients with BMI more than or equal to 35
  • Patients with chest wall deformity
  • Cognitive impairment.

结局指标

主要结局

Postoperative fentanyl consumption using Patient controlled analgesia (PCA) pump

时间窗: 24hours

次要结局

  • Postoperative quality of recovery using QoR-15 scale(Before the surgery and 24 hours postoperatively)
  • Pain assessed using Static and dynamic(on ipsilateral abduction of arm) NRS score(0,2,4,6,12,24 hours after surgery)
  • Incidence of postoperative nausea and vomiting(PONV)(24 hrs)
  • Time of first rescue analgesia given(24 hours)

研究者

发起方
AIIMS New Delhi
申办方类型
Research institution and hospital

研究点 (1)

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