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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Analgesia
• Intervention / Treatment: Procedure: Erector spinae plane block (ESPB); Procedure: Pecto-intercostal fascial plane blok (PIFB)

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi-Ting Chang, Dr.; Phone Number: 4101 (+886)4-23592525; Email: taco@vghtc.gov.tw

Study Locations

• Taiwan
  • Taichung, Taiwan, 407
    • Taichung Veterans General Hospital
    • Contact: Yi-Ting Chang, MD; Phone Number: 4101 (+886)4-23592525; Email: taco@vghtc.gov.tw
    • Principal Investigator: Yi-Ting Chang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group E; Patients who receive erector spinae plane block(ESPB) before cardiac surgery	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.
Active Comparator: Group P; Patients who receive Pecto-intercostal plane block(PIFB) before cardiac surgery	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Taichung Veterans General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: March 10, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Cardiac surgery; Erector spinae plane block; Pecto-intercostal plane block
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia
• Other Study ID Numbers: ESP vs. PIFB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No