A Phase 4 interventional study of LA group and B Group in Analgesia After Pacemaker and AICDS Implantation Pediatrics, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 0 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-05-04.
Sponsored by The University of Texas Health Science Center, Houston · Phase 4, Interventional, and Treatment
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.
The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: LA group
Drug: B Group
In the LA group, only the local anesthetic infiltration will be performed by injecting the numbing medicine ropivacaine into the surgical site.
In the B Group,pectoral (PECS) and transversus thoracic plane(TTP) blocks will be performed by injecting the numbing medicine ropivacaine near the nerves.
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
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.
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
VAS pain scale is a range of scores from 0-10. A higher score indicates greater pain intensity.
Time frame: 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.
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
| Milestone | Local Anesthetic (LA Group) | B Group |
|---|---|---|
| Started | 10 | 9 |
| Completed | 10 | 9 |
| Not completed | 0 | 0 |
| MME per kg | Local Anesthetic (LA Group) | B Group |
|---|---|---|
| Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram | 0.035 ± 0.082 | 0.008 ± 0.026 |
| MME per kg | Local Anesthetic (LA Group) | B Group |
|---|---|---|
| Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram | 0.021 ± 0.044 | 0.008 ± 0.026 |
VAS pain scale is a range of scores from 0-100. A higher score indicates greater pain intensity.
No measurements were reported for this outcome.
VAS pain scale is a range of scores from 0-10. A higher score indicates greater pain intensity.
| score on a scale | Local Anesthetic (LA Group) | B Group |
|---|---|---|
| Pain as Measured by the Visual Analog Scale (VAS) Pain Score | 1.33 ± 2.23 | 3.44 ± 3.46 |
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.
| score on a scale | Local Anesthetic (LA Group) | B Group |
|---|---|---|
| Pain as Measured by the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Assessment Scale | 1.28 ± 2.36 | 1.62 ± 2.92 |
| Participants | Local Anesthetic (LA Group) | B Group |
|---|---|---|
| Number of Patients With the Incidence of Pruritis | 0 | 0 |
| Participants | Local Anesthetic (LA Group) | B Group |
|---|---|---|
| Number of Patients With the Incidence of Nausea/Vomiting | 0 | 0 |
| Participants | Local Anesthetic (LA Group) | B Group |
|---|---|---|
| Number of Patients With Respiratory Depression | 0 | 0 |
| Participants | Local Anesthetic (LA Group) | B Group |
|---|---|---|
| Number of Patients With Local Anesthetic Toxicity | 0 | 0 |
| Participants | Local Anesthetic (LA Group) | B Group |
|---|---|---|
| Number of Patients With Incidence of Pneumothorax | 0 | 0 |
Collected over Up to 48 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Local Anesthetic (LA Group) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| B Group | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Age, Continuous(years) | Local Anesthetic (LA Group) | B Group | Total |
|---|---|---|---|
| Mean | 13.10 ± 2.92 | 8.77 ± 3.96 | 11.05 ± 4.02 |
| Sex: Female, Male(Participants) | Local Anesthetic (LA Group) | B Group | Total |
|---|---|---|---|
| Female | 1 | 5 | 6 |
| Male | 9 | 4 | 13 |
| Race and Ethnicity Not Collected(Participants) | Local Anesthetic (LA Group) | B Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Local Anesthetic (LA Group) | B Group | Total |
|---|---|---|---|
| United States | 10 | 9 | 19 |
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The University of Texas Health Science Center, Houston