Congenital Heart Disease
Conditions
Keywords
pacemaker
Brief summary
This prospective randomized controlled trial aims to examine the effect of subcostal transverse abdominis plane block on the postoperative pain and opioid consumption in patients (12y≤ age) who will undergo epigastric cardiac pacemaker operation. Patients will be allocated to either the SC TAP(subcostal transverse abdominis plane block) group or the control group (no block). Bilateral subcostal transverse abdominis plane block will be performed using 0.25% ropivacaine (0.5mL/kg for each side, MAX 20mL for each side) under ultrasound-guidance at the end of surgery. The pain score at 10 min after PACU admin, 1, 6, 24 hours after the surgery, the total opioid consumption at 12, and 24 hours after the surgery, the total dose of additional rescue analgesia (intravenous ketololac or nalbuphine) at 12 and 24 hour after the surgery will be recorded.
Detailed description
This prospective randomized controlled trial aims to examine the effect of subcostal transverse abdominis plane block on the postoperative pain and opioid consumption in patients (12y≤ age) who will undergo epigastric cardiac pacemaker operation. Patients will be allocated to either the SC TAP(subcostal transverse abdominis plane block) group or the control group (no block). Bilateral subcostal transverse abdominis plane block will be performed using 0.25% ropivacaine (0.5mL/kg for each side, MAX 20mL for each side) under ultrasound-guidance at the end of surgery. The pain score at 10 min after PACU admin, 1, 6, 24 hours after the surgery, the total opioid consumption at 12, and 24 hours after the surgery, the total dose of additional rescue analgesia (intravenous ketololac, acetaminophen, or fentanil) at 12 and 24 hour after the surgery will be recorded.
Interventions
PROCEDURESC TAP
Bilateral subcostal transverse abdominis plane block will be performed using 0.25% ropivacaine (0.5mL/kg for each side, MAX 20mL for each side) under ultrasound-guidance at the end of surgery.
PROCEDUREControl
No regional block is provided at the end of surgery.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Patients who will undergo epigastric cardiac pacemaker operation. (12≤ years)
Exclusion criteria
* Allergy to opioid * Allergy to local anesthetics * Coagulation disorder * Disease in the central and peripheral nervous system * Significant renal impairment (Creatinine\> 3.0 mg/dl) * Significant hepatic impairment (aspartate transaminase\> 120 unit/L, alanine aminotransferase\> 120 unit/L)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score, resting | at 10 minutes after the PACU admin | Pain score at resting is assessed by Numeric rating scale; A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| total opioid consumption at 12, 24 hours after the end of surgery | at 12hours, 24 hours after the end of surgery | total opioid consumption at 12, 24 hours after the end of surgery (IV Nalbuphine 1mg = IV Morphine 1mg = IV Fentanyl 10mcg (0.01mg) |
| Total additional dose of acetaminophen | at 12hours, and 24hours after the end of surgery. | Total additional dose of acetaminophen (mg) |
| Total additional dose of ketorolac | at 12hours, and 24hours after the end of surgery. | Total additional dose of ketorolac (mg) |
| Pain score, coughing | at 1hour, 6hours, and 24hours after the end of surgery. | Pain score at coughing is assessed by Numeric rating scale : A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable. |
| The incidence of side effects of ropivacaine (percent) | within 1 hour after the end of surgery | The incidence of side effects of ropivacaine: Arrhythmia, Hypotension, ST change, Dizziness, Convulsion |
| Hospital stay (days) | within 14 days after the end of surgery | Postoperative hospital stay (days) |
| The incidence of side effects of analgesic medications (percent) | within 24 hours after the end of surgery | The incidence of side effects of analgesic medications: Nausea, Vomit, Constipation, Pruritus, Dizziness, Dry mouth, Sedation |
Countries
South Korea
Outcome results
None listed