Congenital Heart DiseaseNCT04570878
Subcostal Transverse Abdominis Plane Block for Epigastric Cardiac Pacemaker Operation
A study testing SC TAP in people with Congenital Heart Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- SC TAP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jan 2021to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who will undergo epigastric cardiac pacemaker operation. (12≤ years)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Subcostal Transverse Abdominis Plane Block for Epigastric Cardiac Pacemaker Operation: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Congenital Heart Disease
- Being tested
- SC TAP, Control
- Keywords
- pacemaker
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SC TAPProcedure or surgery
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.
ControlProcedure or surgery
No regional block is provided at the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| SC TAP | Experimental | 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. Receives: Procedure: SC TAP |
| Control | Active comparator | No regional block is provided at the end of surgery. Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 10 minutes after the PACU admin
Secondary outcomes (7)
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.
Measured: 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)
Measured: at 12hours, 24 hours after the end of surgery
Total additional dose of acetaminophen
Total additional dose of acetaminophen (mg)
Measured: at 12hours, and 24hours after the end of surgery.
Total additional dose of ketorolac
Total additional dose of ketorolac (mg)
Measured: 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
Measured: 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
Measured: within 1 hour after the end of surgery
Hospital stay (days)
Postoperative hospital stay (days)
Measured: within 14 days after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start15 Jan 2021
- Primary completion9 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570878
- Sponsor's protocol ID
- H-2007-074-1142
- Status last verified
- Oct 2023
- First submitted
- 24 Sep 2020
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcostal Transverse Abdominis Plane Block for Epigastric Cardiac Pacemaker Operation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04570878
- Acronym / sponsor ID
- H-2007-074-1142
- Conditions
- Congenital Heart Disease
- Keywords
- pacemaker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 9 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SC TAP | Experimental | Procedure: SC TAPBilateral 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. |
| Control | Active comparator | Procedure: ControlNo regional block is provided at the end of surgery. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who will undergo epigastric cardiac pacemaker operation. (12≤ years)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SC TAPBilateral 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 or surgery | SC TAP |
| ControlNo regional block is provided at the end of surgery. | Procedure or surgery | Control |
Primary outcome
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.
7 secondary outcomes
Pain score, coughing
Time frame: at 1hour, 6hours, and 24hours after the end of surgery.
total opioid consumption at 12, 24 hours after the end of surgery
Time frame: at 12hours, 24 hours after the end of surgery
Total additional dose of acetaminophen
Time frame: at 12hours, and 24hours after the end of surgery.
Total additional dose of ketorolac
Time frame: at 12hours, and 24hours after the end of surgery.
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 ropivacaine (percent)
Time frame: within 1 hour after the end of surgery
Hospital stay (days)
Time frame: within 14 days after the end of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SC TAP in people with Congenital Heart Disease, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score, resting (time frame: at 10 minutes after the PACU admin). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.