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NCT Number: NCT06322810

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taichung Veterans General Hospital

Taichung, Taiwan, 407

Location status: Recruiting

Location contact

Yi-Ting Chang

CONTACT

[email protected]

(+886)4-23592525 ext. 4101

Yi-Ting Chang, MD

CONTACT

[email protected]

(+886)4-23592525 ext. 4101

Yi-Ting Chang, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 48hr opioid consumption

    Time frame: 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 outcomes

  1. Postoperative static pain scores-Day 1

    Time frame: Day 1

    Pain score reported by patients when resting

  2. Postoperative static pain scores-Day 2

    Time frame: Day 2

    Pain score reported by patients when resting

  3. Postoperative dynamic pain scores-Day 1

    Time frame: Day 1

    Pain score reported by patients when mobilizing or deep coughing

  4. Postoperative dynamic pain scores-Day 2

    Time frame: Day 2

    Pain score reported by patients when mobilizing or deep coughing

  5. postoperative incentive spirometry volume (ml)-Day 1

    Time frame: Day 1

    daily volume of incentive spirometry

  6. postoperative incentive spirometry volume (ml)-Day 2

    Time frame: Day 2

    daily volume of incentive spirometry

  7. postoperative incentive spirometry volume (ml)-Day 3

    Time frame: Day 3

    daily volume of incentive spirometry

  8. QoL15 (POD3)

    Time frame: Day 3

    quality of life questionnaire (QoL15) at postoperative day 3

  9. Serum cytokine (IL-6, IL-8, IL-10) - baseline

    Time frame: During surgery (at the time the induction phase was completed, patients were under general anesthesia, and both arterial line and central venous line were in place)

    Baseline serum inflammatory cytokine, collected from the arterial line and the central venous line after induction of general anesthesia

  10. Serum cytokine (IL-6, IL-8, IL-10)- aortic declamp

    Time frame: Within 10 min after the aortic declamping

    Serum inflammatory cytokines were collected after the aorta was declamped from both the arterial and central venous lines.

  11. Serum cytokine (IL-6, IL-8, IL-10)- 6hrs after aortic decalmped

    Time frame: 6 hours after the aorta was declamped

    Serum inflammatory cytokines were collected 6 hours after the aorta was declamped from both the arterial and central venous lines.

  12. Serum cytokine (IL-6, IL-8, IL-10)-24 hrs after surgery

    Time frame: 24 hours after the surgery

    Serum levels of inflammatory cytokines were collected 24 hours after surgery from both the arterial and central venous lines.

Study contacts

Contact information is provided by the study sponsor or research team.

Yi-Ting Chang, Dr.

CONTACT

[email protected]

(+886)4-23592525 ext. 4101

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Official study title

Comparison of Erector Spiane Plan Block (ESPB) Versus Pecto-intercostal Fascial Block(PIFB) for Analgesia and Respiratory Function Recovery in Cardiac Surgery: a Randomized Control Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 21, 2024
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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