Analgesia
Conditions
Keywords
Erector spinae plane block, Pecto-intercostal plane block, Cardiac surgery
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.
Interventions
PROCEDUREErector 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.
PROCEDUREPecto-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.
Sponsors
Taichung Veterans General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 48hr opioid consumption | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative static pain scores-Day 1 | Day 1 | Pain score reported by patients when resting |
| Postoperative static pain scores-Day 2 | Day 2 | Pain score reported by patients when resting |
| Postoperative dynamic pain scores-Day 1 | Day 1 | Pain score reported by patients when mobilizing or deep coughing |
| Postoperative dynamic pain scores-Day 2 | Day 2 | Pain score reported by patients when mobilizing or deep coughing |
| postoperative incentive spirometry volume (ml)-Day 1 | Day 1 | daily volume of incentive spirometry |
| postoperative incentive spirometry volume (ml)-Day 2 | Day 2 | daily volume of incentive spirometry |
| postoperative incentive spirometry volume (ml)-Day 3 | Day 3 | daily volume of incentive spirometry |
| QoL15 (POD3) | Day 3 | quality of life questionnaire (QoL15) at postoperative 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) | Baseline serum inflammatory cytokine, collected from the arterial line and the central venous line after induction of general anesthesia |
| Serum cytokine (IL-6, IL-8, IL-10)- aortic declamp | Within 10 min after the aortic declamping | Serum inflammatory cytokines were collected after the aorta was declamped from both the arterial and central venous lines. |
| Serum cytokine (IL-6, IL-8, IL-10)- 6hrs after aortic decalmped | 6 hours after the aorta was declamped | Serum inflammatory cytokines were collected 6 hours after the aorta was declamped from both the arterial and central venous lines. |
| Serum cytokine (IL-6, IL-8, IL-10)-24 hrs after surgery | 24 hours after the surgery | Serum levels of inflammatory cytokines were collected 24 hours after surgery from both the arterial and central venous lines. |
Countries
Taiwan
Contacts
CONTACTYi-Ting Chang, Dr.
Outcome results
None listed