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

Analgesia Clinical Trial

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06322810
• Other study ID #: ESP vs. PIFB
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: April 1, 2026

Study information

• Verified date: March 2024
• Source: Taichung Veterans General Hospital
• Contact: Yi-Ting Chang, Dr.
• Phone: (+886)4-23592525
• Email: taco[@]vghtc.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 1, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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