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

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

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.

Interventions

• 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.
• 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.

Primary outcome measures

• 48hr opioid consumption [Time frame: Day 2]

Secondary outcome measures (12)

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

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 2. Anticipated combined major aortic vascular surgery 3. Already admitted to the ICU or on a ventilator before surgery.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Taiwan · 1 center

• Taichung Veterans General Hospital — Taichung

Identifiers

NCT: NCT06322810 · ESP vs. PIFB

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗