Subcostal Transverse Abdominis Plane Block for Epigastric Cardiac Pacemaker Operation

Not Applicable

Completed

• Conditions: Congenital Heart Disease
• Interventions: Procedure: SC TAP; Procedure: Control

• Registration Number: NCT04570878
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2020-09-24
• Study First Submitted QC: 2020-09-24
• Study First Posted: 2020-09-30
• Study Start: 2021-01-15
• Primary Completion: 2023-07-09
• Study Completion: 2023-07-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-29
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SC TAP	SC 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.
Control	Control	No regional block is provided at the end of surgery.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
Total additional dose of acetaminophen	at 12hours, and 24hours after the end of surgery.	Total additional dose of acetaminophen (mg)
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
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)

Trial Locations

Locations (1)

Jin-Tae Kim; 🇰🇷 Seoul, Korea, Republic of