ESP Versus PIFB for Analgesia in Open Cardiac Surgery: a Randomized Control Trial

Not Applicable

Not yet recruiting

• Conditions: Analgesia
• Interventions: Procedure: Erector spinae plane block (ESPB); Procedure: Pecto-intercostal fascial plane blok (PIFB)

• Registration Number: NCT06322810
• Lead Sponsor: Taichung Veterans General Hospital

Brief Summary

This clinical trial compares analgesia efficiency and recovery outcomes between two different fascial plane block techniques (ESPB vs.PIFB) in cardiac surgery patients participant population/health conditions\].

The main questions it aims to answer are:

* Does ESPB provide superior analgesia than PIFB

* Do patients who receive ESPB have better recovery outcomes

Detailed Description

Regional nerve blocks, including Pecto-intercostal block (PIFB) and Erector spinae plane block (ESPB), can provide a certain level of analgesia for thoracic and cardiac surgeries. This study focuses on patients undergoing their first conventional sternotomy for cardiac surgery. They are randomly assigned to receive either PIFB or ESPB for pain relief. Comparisons are made between the two groups for postoperative 48-hour analgesic medication requirements, static and dynamic postoperative pain scores, improvements in postoperative respiratory function, quality of life index (QoL15), and other clinically relevant prognostic indicators.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-10
• Study First Submitted QC: 2024-03-14
• Last Update Submitted: 2024-03-14
• Study First Posted: 2024-03-21
• Last Update Posted: 2024-03-21
• Study Start: 2024-04-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Adults patients, elective and first-time cardiac surgery patients undergoing traditional sternotomy. Procedures include coronary artery bypass surgery, valve repair or replacement surgery, atrial and ventricular septal defect repair surgery, and other open-heart surgeries.

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Exclusion Criteria

• 1. Emergency surgery 2. Anticipated combined major aortic vascular surgery 3. Already admitted to the ICU or on a ventilator before surgery.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group E	Erector spinae plane block (ESPB)	Patients who receive erector spinae plane block(ESPB) before cardiac surgery
Group P	Pecto-intercostal fascial plane blok (PIFB)	Patients who receive Pecto-intercostal plane block(PIFB) before cardiac surgery

Primary Outcome Measures

Name	Time	Method
48hr opioid consumption	Day 2	The primary outcome of this study was the total oral morphine equivalent (OME) dose received within 48 hours after surgery. OME was calculated using a conversion toolkit within our hospital's electronic medical record system, which standardizes opioid analgesic doses to oral morphine equivalents according to established guidelines

Secondary Outcome Measures

Name	Time	Method
Postoperative static pain scores-Day 1	Day 1	Pain score reported by patients when resting
postoperative incentive spirometry volume (ml)-Day 3	Day 3	daily volume of incentive spirometry
Postoperative dynamic pain scores-Day 1	Day 1	Pain score reported by patients when mobilizing or deep coughing
Postoperative dynamic pain scores-Day 2	Day 2	Pain score reported by patients when mobilizing or deep coughing
Postoperative static pain scores-Day 2	Day 2	Pain score reported by patients when resting
QoL15 (pre-op)	Day 0	quality of life questionnaire (QoL15) the day before surgery
postoperative incentive spirometry volume (ml)-Day 1	Day 1	daily volume of incentive spirometry
postoperative incentive spirometry volume (ml)-Day 2	Day 2	daily volume of incentive spirometry
QoL15 (POD3)	Day 3	quality of life questionnaire (QoL15) at postoperative day 3

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan