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

NCT06322810 | Recruiting DMC

• 1 other identifier: ESP vs. PIFB
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Analgesia

Keywords

Erector spinae plane block; Pecto-intercostal plane block; Cardiac surgery

Outcome Measures

Primary Outcomes (1)

• 48hr opioid consumption

  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

  Day 2

Secondary Outcomes (12)

• Postoperative static pain scores-Day 1

  Day 1

• Postoperative static pain scores-Day 2

  Day 2

• Postoperative dynamic pain scores-Day 1

  Day 1

• Postoperative dynamic pain scores-Day 2

  Day 2

• postoperative incentive spirometry volume (ml)-Day 1

  Day 1

Study Arms (2)

Group E

EXPERIMENTAL

Patients who receive erector spinae plane block(ESPB) before cardiac surgery

Procedure: Erector spinae plane block (ESPB)

Group P

ACTIVE COMPARATOR

Patients who receive Pecto-intercostal plane block(PIFB) before cardiac surgery

Procedure: Pecto-intercostal fascial plane blok (PIFB)

Interventions

Erector spinae plane block (ESPB) PROCEDURE

Bilateral ESP: 0.5% ropivacaine 0.3 ml per kg (ideal body weight) each side, 30 min before skin excision. After surgery, use pump to deliver an intermittent automatic bolus of 0.3 ml per kg 0.16% ropivacaine every 4 hours each side.

Group E

Pecto-intercostal fascial plane blok (PIFB) PROCEDURE

Bilateral PIFB: 0.5% ropivacaine 0.3 ml per kg (ideal body weight) each side, 30 min before skin excision. After surgery, use pump to deliver an intermittent automatic bolus of 0.3 ml per kg 0.16% ropivacaine every 4 hours each side.

Group P

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan, 407, Taiwan

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yi-Ting Chang, Dr.

CONTACT

(+886)4-23592525; taco@vghtc.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Anesthesiologist

Study Record Dates

• First Submitted: March 10, 2024
• First Posted: March 21, 2024
• Study Start: November 8, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

TW (1)