Clinical trial NCT04570878: Subcostal Transverse Abdominis Plane Block for Epigastric Cardiac Pacemaker Operation
Official title: Subcostal Transverse Abdominis Plane Block for Epigastric Cardiac Pacemaker Operation: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Keywords: pacemaker
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 22
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Pain score, resting
timeFrame: at 10 minutes after the PACU admin
Secondary outcomes:
measure: Pain score, coughing
timeFrame: at 1hour, 6hours, and 24hours after the end of surgery.
measure: total opioid consumption at 12, 24 hours after the end of surgery
timeFrame: at 12hours, 24 hours after the end of surgery
measure: Total additional dose of acetaminophen
timeFrame: at 12hours, and 24hours after the end of surgery.
measure: Total additional dose of ketorolac
timeFrame: at 12hours, and 24hours after the end of surgery.
measure: The incidence of side effects of analgesic medications (percent)
timeFrame: within 24 hours after the end of surgery
measure: The incidence of side effects of ropivacaine (percent)
timeFrame: within 1 hour after the end of surgery
measure: Hospital stay (days)
timeFrame: within 14 days after the end of surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jin-Tae Kim
Study officials:
References: