跳至主要内容
临床试验/CTRI/2024/08/072269
CTRI/2024/08/072269招募中不适用

Comparison of Transverse Thoracic Muscle Plane Block and Erector Spinae Plane Block for post operative analgesic requirement in Adult Cardiac Surgery: A Randomized Controlled Non-Inferiority trial.

Post Graduate Institute of Medical Education and Research, Chandigarh1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年8月16日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
66
试验地点
1
主要终点
evaluate and compare the cumulative postoperative analgesic requirement (Fentanyl) within the initial 24 hours between two groups: one receiving Thoracic Transversus

研究概览

简要总结

This is a prospective randomised non inferiority trail. It compares the post operative analgesia provided by TTMPB and ESPB in patients of 18 to 65 years of age who undergo midline sternotomy for procedures like CABG with only venous graft, MVR, AVR, DVR, VSD and ASD. Patients are screened for inclusion in the study during the pre op evaluation and if they meet the criteria of inclusion and exclusion they are explained about the study and its risk- benefits, written informed consent is taken and also the patient is educated about the NRS pain score. in the OT a skilled anesthetist would provide either of the block depending on the computer generated  sequence after induction of the case. during operation  fentanyl infusion is maintained and extra bolus dose s are given if required. intraoperative vitals and requirement of fentanyl is noted. Post op patients is transfered to ctvs ICU and  hemodynamics guided boluses of fentanyl and  provided and note is made. Patient is extubated once they meet the criteria to extubate and time to extubation noted. Post extubation  NRS scores noted at predefined intervals and in case of complaints of pain. NRS guided fentanyl bolus doses are given and total quantity of fentanyl requirements post op is also noted for post op 24 hrs.

A total of 66 cases are considered to be taken up for the study and conclusion regarding the non inferiority of TTMPB to ESPB will be drawn based on statistical calculation from the data collected.

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
All

入选标准

  • Patients with ASA status I and II undergoing elective cardiac procedure through midline sternotomy, CABG where only venous graft is planned ,valve replacement surgery (MVR, AVR, DVR), septal defect surgery (ASD, VSD).

排除标准

  • patients who do not volunteer to participate, those who have Ejection fraction less than 35%, those with low cardiac output syndromes.
  • on pre operative ionotropic support, wi9th reccurrent vascular anomalies.
  • those who have allergy to local anaesthetics, those who have severe PAH.
  • If its a reexplporation.

结局指标

主要结局

evaluate and compare the cumulative postoperative analgesic requirement (Fentanyl) within the initial 24 hours between two groups: one receiving Thoracic Transversus

时间窗: 24hrs

Thoracic Muscle Plane Block (TTMPB) ,

时间窗: 24hrs

and the other receiving Erector Spinae Plane Block (ESPB)

时间窗: 24hrs

次要结局

  • To assess the time to first rescue analgesic (Fentanyl 0.5 mcg/kg) in each group (in(min) to relate to the pain free time.)

研究者

发起方
Post Graduate Institute of Medical Education and Research, Chandigarh
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Amrita Pramod

PGIMER, Chandigargh

研究点 (1)

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