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

NCT ID: NCT06322810

Last Updated: 2025-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-08

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group E

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

Group Type EXPERIMENTAL

Erector spinae plane block (ESPB)

Intervention Type 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 P

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

Group Type ACTIVE_COMPARATOR

Pecto-intercostal fascial plane blok (PIFB)

Intervention Type 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.

Interventions

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Erector spinae plane block (ESPB)

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.

Intervention Type PROCEDURE

Pecto-intercostal fascial plane blok (PIFB)

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Exclusion Criteria

* 1\. Emergency surgery 2. Anticipated combined major aortic vascular surgery 3. Already admitted to the ICU or on a ventilator before surgery.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taichung Veterans General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yi-Ting Chang

Attending Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Taichung Veterans General Hospital

Taichung, Taiwan, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yi-Ting Chang, Dr.

Role: CONTACT

(+886)4-23592525 ext. 4101

Facility Contacts

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Yi-Ting Chang, MD

Role: primary

(+886)4-23592525 ext. 4101

Yi-Ting Chang

Role: backup

(+886)4-23592525 ext. 4101

Other Identifiers

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ESP vs. PIFB

Identifier Type: -

Identifier Source: org_study_id

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