Subcostal Transverse Abdominis Plane Block for Epigastric Cardiac Pacemaker Operation

Seoul National University

Status: Completed

Conditions: Congenital Heart Disease

Treatments: Procedure: Control; Procedure: SC TAP

Study type: Interventional

Funder types: Other

Identifiers

NCT04570878

H-2007-074-1142

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

SC TAP

Experimental group

Description:

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.

Treatment:

Procedure: SC TAP

Control

Active Comparator group

Description:

No regional block is provided at the end of surgery.

Treatment:

Procedure: Control