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临床试验/CTRI/2024/07/069787
CTRI/2024/07/069787尚未招募不适用

A Prospective Study to Assess the Efficacy of USG Guided Erector Spinae Plane Block (ESPB) for Perioperative Analgesia in Patients Undergoing Minimally Invasive Cardiac Surgery (MICS)

Lokmanya tilakMunicipal Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年7月15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
30
试验地点
1
主要终点
Intraoperative analgesics requirement

研究概览

简要总结

This prospective observational study aims to evaluate the efficacy of ultrasound-guided Erector Spinae Plane Block (ESPB) for perioperative analgesia in patients undergoing Minimally Invasive Cardiac Surgery (MICS) at Lokmanya Tilak Municipal General Hospital, Mumbai.

Objective: -The primary objective of this study is to assess the impact of ESPB on intraoperative analgesic requirements, duration of postoperative analgesia, and the need for rescue analgesics within the first 24 hours post-surgery. Secondary objectives include evaluating extubation time, time to first mobilization, and patient and surgeon satisfaction scores.

Methodology:- The study will include 30 adult patients scheduled for various MICS procedures, such as coronary artery bypass surgery, valve repairs, or septal defect corrections. Patients meeting inclusion criteria (age over 18 years, elective surgery, ability to provide informed consent) and not having any exclusion criteria (allergy to local anesthetics, history of substance abuse) will be enrolled after obtaining informed consent. Standard monitoring and anesthesia induction will be performed according to institutional protocols, with intravenous dexmedetomidine and atracurium used for maintenance. ESPB will be performed under ultrasound guidance at the T5 level using a high-frequency linear ultrasound transducer and a 20-gauge echogenic needle. A total of 20 ml of Ropivacaine 0.125% with Dexamethasone 8 mg will be administered in the ESPB procedure.

Outcome Measures:-Primary outcomes include intraoperative analgesic requirements, duration of analgesia post-administration, and the need for rescue analgesics within 24 hours. Secondary outcomes involve assessing extubation time, time to first mobilization, and patient and surgeon satisfaction scores. Pain intensity will be assessed using the Numerical Rating Scale (NRS) at baseline, intraoperatively, and at 0, 2, 6, 12, and 24 hours postoperatively. Rescue analgesic administration will be recorded and analyzed for efficacy.

Statistical Analysis:-Descriptive statistics will summarize demographic and clinical characteristics, while inferential statistics (e.g., Z-test, Mc Nemar’s Chi-square test) will compare pre- and post-block outcomes. Statistical analysis will be conducted using STATA version 10.1, with a significance level set at p < 0.05.

Conclusion:- This study aims to contribute evidence on the efficacy of ESPB in enhancing perioperative pain management and recovery outcomes in patients undergoing MICS. The findings are expected to support the adoption of ESPB as an alternative or adjunct to systemic opioids in cardiac surgery, potentially leading to improved patient care and outcomes.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patient undergoing MICS Many types of heart procedure may be performed with MICS including.
  • coronary artery bypass graft, aortic valve replacement, atrial septal defect, mital valve repair or replacement, tricuspid valve repair or replacement.

排除标准

  • Patients refusal to participate in study -Allergy to Local anaesthetic agents -History of substance abuse -Emergency Surgery.

结局指标

主要结局

Intraoperative analgesics requirement

时间窗: 0 HRS 2HRS 6HRS 12HRS 24 HRS

Duration of Erector spinae block

时间窗: 0 HRS 2HRS 6HRS 12HRS 24 HRS

Post op Requirement of Rescue analgesics in 24 hrs

时间窗: 0 HRS 2HRS 6HRS 12HRS 24 HRS

次要结局

  • 1. Extubation Time(2. 1st Mobilisation time)

研究者

发起方
Lokmanya tilakMunicipal Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dnyaneshwar Wanve

Lokmanya tilak municipal medical college and Lokmanya tilak municipal general hospital sion Mumbai

研究点 (1)

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