Subcostal Transverse Abdominis Plane Block for Epigastric Cardiac Pacemaker Operation

Sponsor
Seoul National University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04570878
Collaborator
(none)
22
1
2
35.5
0.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: SC TAP
  • Procedure: Control
N/A

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

Study Type:
Interventional
Anticipated 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 :
Jan 15, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

Primary Outcome Measures

  1. Pain score, resting [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 [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 [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 [at 12hours, and 24hours after the end of surgery.]

    Total additional dose of acetaminophen (mg)

  4. Total additional dose of ketorolac [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) [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) [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) [within 14 days after the end of surgery]

    Postoperative hospital stay (days)

  8. Neurological Pupil indexTM (NPi) [at 1 hour after the end of surgery]

    measured by pupillometer

  9. pupil constriction velocity (CV) [at 1 hour after the end of surgery]

    measured by pupillometer

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Jin-Tae Kim Seoul Korea, Republic of

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jin-Tae Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT04570878
Other Study ID Numbers:
  • H-2007-074-1142
First Posted:
Sep 30, 2020
Last Update Posted:
Jun 3, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jin-Tae Kim, Professor, Seoul National University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 3, 2022