Subcostal Transverse Abdominis Plane Block for Epigastric Cardiac Pacemaker Operation

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04570878
• Other study ID #: H-2007-074-1142
• Status: Completed
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: October 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 31, 2023
• Est. primary completion date: July 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

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.
• Control
No regional block is provided at the end of surgery.

Locations

Country	Name	City	State
Korea, Republic of	Jin-Tae Kim	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	Total additional dose of acetaminophen	Total additional dose of acetaminophen (mg)	at 12hours, and 24hours after the end of surgery.
Secondary	Total additional dose of ketorolac	Total additional dose of ketorolac (mg)	at 12hours, and 24hours after the end of surgery.
Secondary	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
Secondary	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
Secondary	Hospital stay (days)	Postoperative hospital stay (days)	within 14 days after the end of surgery