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Subcostal Transverse Abdominis Plane Block for Epigastric Cardiac Pacemaker Operation

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ClinicalTrials.gov Identifier: NCT04570878
Recruitment Status : Recruiting
First Posted : September 30, 2020
Last Update Posted : February 4, 2021
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Congenital Heart Disease Procedure: SC TAP Procedure: Control Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Subcostal Transverse Abdominis Plane Block for Epigastric Cardiac Pacemaker Operation: a Randomized Controlled Trial
Actual Study Start Date : January 15, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Pain score, resting [ Time Frame: 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 :
  1. Pain score, coughing [ Time Frame: 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.

  2. total opioid consumption at 12, 24 hours after the end of surgery [ Time Frame: 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)

  3. Total additional dose of acetaminophen [ Time Frame: at 12hours, and 24hours after the end of surgery. ]
    Total additional dose of acetaminophen (mg)

  4. Total additional dose of ketorolac [ Time Frame: at 12hours, and 24hours after the end of surgery. ]
    Total additional dose of ketorolac (mg)

  5. The incidence of side effects of analgesic medications (percent) [ Time Frame: within 24 hours after the end of surgery ]
    The incidence of side effects of analgesic medications: Nausea, Vomit, Constipation, Pruritus, Dizziness, Dry mouth, Sedation

  6. The incidence of side effects of ropivacaine (percent) [ Time Frame: within 1 hour after the end of surgery ]
    The incidence of side effects of ropivacaine: Arrhythmia, Hypotension, ST change, Dizziness, Convulsion

  7. Hospital stay (days) [ Time Frame: within 14 days after the end of surgery ]
    Postoperative hospital stay (days)

  8. Neurological Pupil indexTM (NPi) [ Time Frame: at 1 hour after the end of surgery ]
    measured by pupillometer

  9. pupil constriction velocity (CV) [ Time Frame: at 1 hour after the end of surgery ]
    measured by pupillometer


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04570878


Contacts
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Contact: Young Eun Jang, MD 082-02-2072-3665 na0ag2@hotmail.com
Contact: Jin-Tae Kim, MD,PhD 082-02-2072-3661 jintae73@gmail.com

Locations
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Korea, Republic of
Jin-Tae Kim Recruiting
Seoul, Korea, Republic of
Contact: Jin-Tae Kim, MD. PhD    82-2-2072-3295    kimjintae73@dreamwiz.com   
Sponsors and Collaborators
Seoul National University Hospital
More Information
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Responsible Party: Jin-Tae Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT04570878    
Other Study ID Numbers: H-2007-074-1142
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jin-Tae Kim, Seoul National University Hospital:
pacemaker
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities