跳至主要内容
临床试验/CTRI/2024/06/069122
CTRI/2024/06/069122尚未招募3 期

Comparison of ultrasound guided pecto intercostal fascial block and transversus thoracic muscle plane block for quality of recovery after cardiac surgery requiring median sternotomy A prospective randomize double blind study

Dr Monika Soni1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Quality of recovery, using the Quality of Recovery- 15 (QoR- 15) scale at 24 h post- operatively

研究概览

简要总结

A total of 60 patients posted for elective cardiac surgery requiring median sternotomy will be randomly divided into two equal groups (30 each), group PIFB and group TTMPB. We will compare the effectiveness of ultrasound- Guided Pecto- Intercostal Fascial Block and Transversus Thoracic Muscle Plane Block. Post operatively, pain scores will be recorded at rest and during coughing using 11- point Numeric Rating Scale (NRS) at 0,3,6,12,12, and 24 hours. On assessment, if NRS is 3 or more, first rescue analgesia (iv diclofenac sodium 1mg/kg) will be administered. Patient will be reassessed after 30 minutes; if NRS persists to be 3 or more, a second rescue analgesia (iv tramadol 2mg/kg) will be given. Duration of analgesia will be recorded. Quality of recovery (QoR) will be assessed using Quality of Recovery- 15 (QoR- 15) scale at 24 hours post operatively. Patients satisfaction with pain management will be evaluated using a five- point verbal satisfaction scale (Likert scale) at the end of first 24 postoperative hours. Hemodynamic parameters and side effects like respiratory depression and pruritis will be recorded.

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 70.00 Year(s)(—)
性别
All

入选标准

  • ASA physical status 2 or 3
  • Patients able to comprehend and willing to participate.
  • Patients scheduled for elective on pump cardiac surgery requiring median sternotomy.

排除标准

  • Patients refusal to participate
  • Patients with left venticular ejection fraction less than 30%
  • Emergent or redo surgeries
  • Studied drug allergy
  • Hematological disease or h/o bleeding diathesis
  • Chronic Opioids use
  • Severe organ dysfunction (Renal/ Liver insufficiencies).

结局指标

主要结局

Quality of recovery, using the Quality of Recovery- 15 (QoR- 15) scale at 24 h post- operatively

时间窗: At 24 h post- operatively

次要结局

  • To assess pain score using NRS scale upto 24 hr, time to first rescue analgesia use, total analgesic consumption upto 24 hr, patients satisfaction and any adverse effects seen.(pain score will be recorded at rest and during coughing using NRS scores at 0, 3, 6, 12, 18 and 24 hours.)

研究者

发起方
Dr Monika Soni
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Monika Soni

Indira Gandhi Institute of Medical Sciences

研究点 (1)

Loading locations...

相似试验