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Clinical Trials/NCT06322810
NCT06322810
Recruiting
Not Applicable

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

Taichung Veterans General Hospital1 site in 1 country80 target enrollmentNovember 8, 2024

Overview

Phase
Not Applicable
Intervention
Erector spinae plane block (ESPB)
Conditions
Analgesia
Sponsor
Taichung Veterans General Hospital
Enrollment
80
Locations
1
Primary Endpoint
48hr opioid consumption
Status
Recruiting
Last Updated
2 months ago

Overview

Brief 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

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.

Registry
clinicaltrials.gov
Start Date
November 8, 2024
End Date
December 31, 2026
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yi-Ting Chang

Attending Anesthesiologist

Taichung Veterans General Hospital

Eligibility Criteria

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
  • Anticipated combined major aortic vascular surgery
  • Already admitted to the ICU or on a ventilator before surgery.

Arms & Interventions

Group E

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

Intervention: Erector spinae plane block (ESPB)

Group P

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

Intervention: Pecto-intercostal fascial plane blok (PIFB)

Outcomes

Primary Outcomes

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

  • Postoperative static pain scores-Day 1(Day 1)
  • postoperative incentive spirometry volume (ml)-Day 3(Day 3)
  • Postoperative dynamic pain scores-Day 1(Day 1)
  • Postoperative dynamic pain scores-Day 2(Day 2)
  • postoperative incentive spirometry volume (ml)-Day 2(Day 2)
  • postoperative incentive spirometry volume (ml)-Day 1(Day 1)
  • Postoperative static pain scores-Day 2(Day 2)
  • QoL15 (POD3)(Day 3)
  • Serum cytokine (IL-6, IL-8, IL-10) - baseline(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))
  • Serum cytokine (IL-6, IL-8, IL-10)- aortic declamp(Within 10 min after the aortic declamping)
  • Serum cytokine (IL-6, IL-8, IL-10)- 6hrs after aortic decalmped(6 hours after the aorta was declamped)
  • Serum cytokine (IL-6, IL-8, IL-10)-24 hrs after surgery(24 hours after the surgery)

Study Sites (1)

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