Subcostal Transverse Abdominis Plane Block for Epigastric Cardiac Pacemaker Operation
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 |
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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
Arms and Interventions
Arm | Intervention/Treatment |
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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.
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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.
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Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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)
- Total additional dose of acetaminophen [at 12hours, and 24hours after the end of surgery.]
Total additional dose of acetaminophen (mg)
- Total additional dose of ketorolac [at 12hours, and 24hours after the end of surgery.]
Total additional dose of ketorolac (mg)
- 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
- 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
- Hospital stay (days) [within 14 days after the end of surgery]
Postoperative hospital stay (days)
- Neurological Pupil indexTM (NPi) [at 1 hour after the end of surgery]
measured by pupillometer
- pupil constriction velocity (CV) [at 1 hour after the end of surgery]
measured by pupillometer
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients who will undergo epigastric cardiac pacemaker operation. (12≤ years)
Exclusion Criteria:
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Allergy to opioid
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Allergy to local anesthetics
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Coagulation disorder
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Disease in the central and peripheral nervous system
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Significant renal impairment (Creatinine> 3.0 mg/dl)
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Significant hepatic impairment (aspartate transaminase> 120 unit/L, alanine aminotransferase> 120 unit/L)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- H-2007-074-1142