Subcostal Transverse Abdominis Plane Block for Epigastric Cardiac Pacemaker Operation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Congenital Heart Disease

Intervention / Treatment
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* Procedure: SC TAP
* Procedure: Control


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SC TAP<br>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<br>* 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.<br>|
| Active Comparator: Control<br>No regional block is provided at the end of surgery. | Procedure: Control<br>* No regional block is provided at the end of surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 | 
| Total additional dose of acetaminophen | Total additional dose of acetaminophen (mg) | at 12hours, and 24hours after the end of surgery. | 
| Total additional dose of ketorolac | Total additional dose of ketorolac (mg) | at 12hours, and 24hours after the end of surgery. | 
| 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 | 
| 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 | 
| Hospital stay (days) | Postoperative hospital stay (days) | within 14 days after the end of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pacemaker