NCT04570878

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 30, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

January 15, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2023

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

2.5 years

First QC Date

September 24, 2020

Last Update Submit

October 29, 2023

Conditions

Congenital Heart Disease

Keywords

pacemaker

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Pain score, coughing

    at 1hour, 6hours, and 24hours after the end of surgery.

  • total opioid consumption at 12, 24 hours after the end of surgery

    at 12hours, 24 hours after the end of surgery

  • Total additional dose of acetaminophen

    at 12hours, and 24hours after the end of surgery.

  • Total additional dose of ketorolac

    at 12hours, and 24hours after the end of surgery.

  • The incidence of side effects of analgesic medications (percent)

    within 24 hours after the end of surgery

  • +2 more secondary outcomes

Study Arms (2)

SC TAP

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

No regional block is provided at the end of surgery.

Procedure: Control

Interventions

SC TAPPROCEDURE

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.

SC TAP
ControlPROCEDURE

No regional block is provided at the end of surgery.

Control

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patients who will undergo epigastric cardiac pacemaker operation. (12≤ years)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jin-Tae Kim

Seoul, South Korea

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 24, 2020

First Posted

September 30, 2020

Study Start

January 15, 2021

Primary Completion

July 9, 2023

Study Completion

July 31, 2023

Last Updated

October 31, 2023

Record last verified: 2023-10

Locations

KR(1)