Comparative Efficacy of Regional Blocks within a Transitional Pain Service Model: TTPB with SAPB versus TTPB with Intercostal Nerve Block for Post-Sternotomy and Intercostal drain Pain – A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- NA
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative pain intensity, measured using a validated pain scale (e.g.Visual Analogue Scale [VAS]) at rest and on coughing/movement over the first 24–48 hours after surgery.
研究概览
简要总结
This study is a prospective, randomized, active-controlled, parallel-group interventional trial designed to evaluate the comparative efficacy of regional anesthesia techniques within a transitional pain service model for patients undergoing median sternotomy with intercostal drain placement. Patients will be randomized to receive either transversus thoracic plane block (TTPB) combined with serratus anterior plane block (SAPB) or TTPB combined with intercostal nerve block (ICNB).
The primary outcome is postoperative pain intensity (Numeric Rating Scale, at rest and on coughing) over the first 24 hours after surgery. Secondary outcomes include cumulative opioid consumption, time to first rescue analgesia, incidence of postoperative nausea and vomiting, block-related complications, patient satisfaction, and length of ICU/hospital stay. Pain scores and analgesic requirements will be assessed at multiple time points up to 48 hours postoperatively, with follow-up at 7 and 30 days for safety and persistent pain assessment.
The trial aims to determine which block combination provides superior analgesia and enhanced recovery, potentially guiding best practices in post-sternotomy pain management within a structured transitional pain service model.
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 75.00 Year(s)(—)
- 性别
- All
入选标准
- •ASA I and II Elective cardiac surgery via median sternotomy Extubated within 24 hour.
排除标准
- •Refusal to participate Coagulopathy Local infection at block site Allergy to local anaesthetic Emergency re exploration Hemodynamic instability post surgery.
结局指标
主要结局
Postoperative pain intensity, measured using a validated pain scale (e.g.Visual Analogue Scale [VAS]) at rest and on coughing/movement over the first 24–48 hours after surgery.
时间窗: After extubation | 30 min post extubation | 1 hour post extubation | 2 hour post extubation | 3 hour | 6 hour | 12 hour | 24 hour
次要结局
- Opioid consumption (e.g., total tramadol-equivalent dose in the first 24–48 hours).(2. Time to first rescue analgesia after block.)
研究者
Shubhi kapuskar
NSCB MEDICAL COLLEGE JABALPUR
