Analgesia After PacemakerPhase 4NCT04184349
Truncal Ultrasound Guided Regional Anesthesia for Implantation and Revision of Automatic Implantable Cardioverter Defibrillators (AICDs) and Pacemakers in Pediatric Patients
A Phase 4 study testing LA group and B Group in people with Analgesia After Pacemaker and AICDS Implantation Pediatrics, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to determine the efficacy and safety of truncal blocks for pacemaker and Automatic Implantable Cardioverter Defibrillator implantation in children and to prospectively evaluate whether there is a decrease in amount of narcotic medications need and track complications. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Analgesia After Pacemaker, AICDS Implantation Pediatrics
- What is being tested?
- LA group and B Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 9 Jun 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients undergoing implantation or revision of pacemaker or AICD in the pediatric cath lab
Who cannot join
- parent or patient refusal
- use of narcotic medications prior to procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Truncal Ultrasound Guided Regional Anesthesia for Implantation and Revision of AICDs and Pacemakers in Pediatric Patients
The purpose of this study is to determine the efficacy and safety of truncal blocks for pacemaker and Automatic Implantable Cardioverter Defibrillator implantation in children and to prospectively evaluate whether there is a decrease in amount of narcotic medications need and track complications.
- Being tested
- LA group, B Group
- Keywords
- pacemaker, AICDS, regional anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LA groupDrug
In the LA group, only the local anesthetic infiltration will be performed by injecting the numbing medicine ropivacaine into the surgical site.
B GroupDrug
In the B Group,pectoral (PECS) and transversus thoracic plane(TTP) blocks will be performed by injecting the numbing medicine ropivacaine near the nerves.
| Study group | Role | What they receive |
|---|---|---|
| Local Anesthetic (LA Group) | Active comparator | Not described Receives: Drug: LA group |
| B group | Active comparator | Not described Receives: Drug: B Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram
Measured: From 24 hours after procedure to 48 hours after procedure
Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram
Measured: up to 24 hours after procedure
Secondary outcomes (8)
Pain as Measured by the Visual Analog Scale (VAS) Pain Score
VAS pain scale is a range of scores from 0-100. A higher score indicates greater pain intensity.
Measured: up to 1.5 hours post procedure in post anesthesia care unit (PACU)
Pain as Measured by the Visual Analog Scale (VAS) Pain Score
VAS pain scale is a range of scores from 0-10. A higher score indicates greater pain intensity.
Measured: up to 24 hours post procedure
Pain as Measured by the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Assessment Scale
Face, Legs, Activity, Cry, Consolability (FLACC) Pain Assessment measures pain with a total score that ranges from 0 to 10; a higher score indicating greater pain.
Measured: up to 6 hours post procedure in post anesthesia care unit (PACU)
Number of Patients With the Incidence of Pruritis
Measured: up to 48 hours after procedure
Number of Patients With the Incidence of Nausea/Vomiting
Measured: up to 48 hours after procedure
Number of Patients With Respiratory Depression
Measured: up to 48 hours after procedure
Number of Patients With Local Anesthetic Toxicity
Measured: up to 48 hours after procedure
Number of Patients With Incidence of Pneumothorax
Measured: up to 48 hours after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start1 Oct 2020
- Primary completion9 Jun 2022
- Study completion9 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Analgesia After PacemakerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olga Pawelek, The University of Texas Health Science Center, Houston
- Investigators
- Olga Pewelek, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184349
- Sponsor's protocol ID
- HSC-MS-19-0760
- Status last verified
- May 2025
- First submitted
- 7 Nov 2019
- Last updated
- 4 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Truncal Ultrasound Guided Regional Anesthesia for Implantation and Revision of AICDs and Pacemakers in Pediatric Patients
- ClinicalTrials.gov ID
- NCT04184349
- Acronym / sponsor ID
- HSC-MS-19-0760
- Keywords
- pacemaker, AICDS, regional anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 9 Jun 2022 (actual)
- Study completion
- 9 Jun 2022 (actual)
- First posted
- 3 Dec 2019 (actual)
- Results
- Posted 4 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the efficacy and safety of truncal blocks for pacemaker and Automatic Implantable Cardioverter Defibrillator implantation in children and to prospectively evaluate whether there is a decrease in amount of narcotic medications need and track complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local Anesthetic (LA Group) | Active comparator | Drug: LA group |
| B group | Active comparator | Drug: B Group |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients undergoing implantation or revision of pacemaker or AICD in the pediatric cath lab
Key exclusion criteria (2 listed)
- parent or patient refusal
- use of narcotic medications prior to procedure
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 |
|---|---|---|
| LA groupIn the LA group, only the local anesthetic infiltration will be performed by injecting the numbing medicine ropivacaine into the surgical site. | Drug | Local Anesthetic (LA Group) |
| B GroupIn the B Group,pectoral (PECS) and transversus thoracic plane(TTP) blocks will be performed by injecting the numbing medicine ropivacaine near the nerves. | Drug | B group |
Primary outcome
Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram
Time frame: From 24 hours after procedure to 48 hours after procedure
Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram
Time frame: up to 24 hours after procedure
8 secondary outcomes
Pain as Measured by the Visual Analog Scale (VAS) Pain Score
Time frame: up to 1.5 hours post procedure in post anesthesia care unit (PACU)
Pain as Measured by the Visual Analog Scale (VAS) Pain Score
Time frame: up to 24 hours post procedure
Pain as Measured by the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Assessment Scale
Time frame: up to 6 hours post procedure in post anesthesia care unit (PACU)
Number of Patients With the Incidence of Pruritis
Time frame: up to 48 hours after procedure
Number of Patients With the Incidence of Nausea/Vomiting
Time frame: up to 48 hours after procedure
Number of Patients With Respiratory Depression
Time frame: up to 48 hours after procedure
Number of Patients With Local Anesthetic Toxicity
Time frame: up to 48 hours after procedure
Number of Patients With Incidence of Pneumothorax
Time frame: up to 48 hours after procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Olga Pewelek, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing LA group and B Group in people with Analgesia After Pacemaker and AICDS Implantation Pediatrics, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 2 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 4 May 2025. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram (time frame: From 24 hours after procedure to 48 hours after procedure). The study lists 2 primary outcomes in all. 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 4 May 2025.