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Subcostal Transverse Abdominis Plane Block for Epigastric Cardiac Pacemaker Operation

Primary Purpose

Congenital Heart Disease

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
SC TAP
Control
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Disease focused on measuring pacemaker

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Jin-Tae KimRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SC TAP

Control

Arm 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.

No regional block is provided at the end of surgery.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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)
Total additional dose of acetaminophen
Total additional dose of acetaminophen (mg)
Total additional dose of ketorolac
Total additional dose of ketorolac (mg)
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
The incidence of side effects of ropivacaine (percent)
The incidence of side effects of ropivacaine: Arrhythmia, Hypotension, ST change, Dizziness, Convulsion
Hospital stay (days)
Postoperative hospital stay (days)
Neurological Pupil indexTM (NPi)
measured by pupillometer
pupil constriction velocity (CV)
measured by pupillometer

Full Information

First Posted
September 24, 2020
Last Updated
June 2, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04570878
Brief Title
Subcostal Transverse Abdominis Plane Block for Epigastric Cardiac Pacemaker Operation
Official Title
Subcostal Transverse Abdominis Plane Block for Epigastric Cardiac Pacemaker Operation: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
Keywords
pacemaker

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SC TAP
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
No regional block is provided at the end of surgery.
Intervention Type
Procedure
Intervention Name(s)
SC TAP
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
No regional block is provided at the end of surgery.
Primary Outcome Measure Information:
Title
Pain score, resting
Description
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.
Time Frame
at 10 minutes after the PACU admin
Secondary Outcome Measure Information:
Title
Pain score, coughing
Description
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.
Time Frame
at 1hour, 6hours, and 24hours after the end of surgery.
Title
total opioid consumption at 12, 24 hours after the end of surgery
Description
total opioid consumption at 12, 24 hours after the end of surgery (IV Nalbuphine 1mg = IV Morphine 1mg = IV Fentanyl 10mcg (0.01mg)
Time Frame
at 12hours, 24 hours after the end of surgery
Title
Total additional dose of acetaminophen
Description
Total additional dose of acetaminophen (mg)
Time Frame
at 12hours, and 24hours after the end of surgery.
Title
Total additional dose of ketorolac
Description
Total additional dose of ketorolac (mg)
Time Frame
at 12hours, and 24hours after the end of surgery.
Title
The incidence of side effects of analgesic medications (percent)
Description
The incidence of side effects of analgesic medications: Nausea, Vomit, Constipation, Pruritus, Dizziness, Dry mouth, Sedation
Time Frame
within 24 hours after the end of surgery
Title
The incidence of side effects of ropivacaine (percent)
Description
The incidence of side effects of ropivacaine: Arrhythmia, Hypotension, ST change, Dizziness, Convulsion
Time Frame
within 1 hour after the end of surgery
Title
Hospital stay (days)
Description
Postoperative hospital stay (days)
Time Frame
within 14 days after the end of surgery
Title
Neurological Pupil indexTM (NPi)
Description
measured by pupillometer
Time Frame
at 1 hour after the end of surgery
Title
pupil constriction velocity (CV)
Description
measured by pupillometer
Time Frame
at 1 hour after the end of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Young Eun Jang, MD
Phone
082-02-2072-3665
Email
na0ag2@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jin-Tae Kim, MD,PhD
Phone
082-02-2072-3661
Email
jintae73@gmail.com
Facility Information:
Facility Name
Jin-Tae Kim
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Tae Kim, MD. PhD
Phone
82-2-2072-3295
Email
kimjintae73@dreamwiz.com

12. IPD Sharing Statement

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Subcostal Transverse Abdominis Plane Block for Epigastric Cardiac Pacemaker Operation

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