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

Taichung Veterans General Hospital80 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Analgesia

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.

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Taichung Veterans General Hospital

Taichung, Taiwan, Taiwan

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: Day 2

Secondary Outcomes

Postoperative static pain scores-Day 1

Pain score reported by patients when resting

Time frame: Day 1

Postoperative static pain scores-Day 2

Pain score reported by patients when resting

Time frame: Day 2

Postoperative dynamic pain scores-Day 1

Pain score reported by patients when mobilizing or deep coughing

Time frame: Day 1

Postoperative dynamic pain scores-Day 2

Pain score reported by patients when mobilizing or deep coughing

Time frame: Day 2

postoperative incentive spirometry volume (ml)-Day 1

daily volume of incentive spirometry

Time frame: Day 1

postoperative incentive spirometry volume (ml)-Day 2

daily volume of incentive spirometry

Time frame: Day 2

postoperative incentive spirometry volume (ml)-Day 3

daily volume of incentive spirometry

Central Contacts

Yi-Ting Chang, Dr.

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.