Subcostal Transverse Abdominis Plane Block for Epigastric Cardiac Pacemaker Operation

Subcostal Transverse Abdominis Plane Block for Epigastric Cardiac Pacemaker Operation: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease
• Intervention / Treatment: Procedure: Control; Procedure: SC TAP

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Young Eun Jang, MD; Phone Number: 082-02-2072-3665; Email: na0ag2@hotmail.com
• Study Contact Backup: Name: Jin-Tae Kim, MD,PhD; Phone Number: 082-02-2072-3661; Email: jintae73@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Jin-Tae Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Active Comparator: Control; No regional block is provided at the end of surgery.	Procedure: Control; No regional block is provided at the end of surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score, resting	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.	at 10 minutes after the PACU admin

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score, coughing	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.	at 1hour, 6hours, and 24hours after the end of surgery.
total opioid consumption at 12, 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)	at 12hours, 24 hours after the end of surgery
Total additional dose of acetaminophen	Total additional dose of acetaminophen (mg)	at 12hours, and 24hours after the end of surgery.
Total additional dose of ketorolac	Total additional dose of ketorolac (mg)	at 12hours, and 24hours after the end of surgery.
The incidence of side effects of analgesic medications (percent)	The incidence of side effects of analgesic medications: Nausea, Vomit, Constipation, Pruritus, Dizziness, Dry mouth, Sedation	within 24 hours after the end of surgery
The incidence of side effects of ropivacaine (percent)	The incidence of side effects of ropivacaine: Arrhythmia, Hypotension, ST change, Dizziness, Convulsion	within 1 hour after the end of surgery
Hospital stay (days)	Postoperative hospital stay (days)	within 14 days after the end of surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Actual): July 9, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: September 24, 2020
• First Submitted That Met QC Criteria: September 24, 2020
• First Posted (Actual): September 30, 2020

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 29, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: pacemaker
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: H-2007-074-1142

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No