Trial Outcomes & Findings for Truncal Ultrasound Guided Regional Anesthesia for Implantation and Revision of Automatic Implantable Cardioverter Defibrillators (AICDs) and Pacemakers in Pediatric Patients (NCT NCT04184349)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

19 participants

Primary outcome timeframe

From 24 hours after procedure to 48 hours after procedure

Results posted on

2025-05-04

Participant Flow

Participant milestones

Participant milestones
Measure	Local Anesthetic (LA Group) LA group: In the LA group, only the local anesthetic infiltration will be performed by injecting the numbing medicine ropivacaine into the surgical site.	B Group B Group: In the B Group,pectoral (PECS) and transversus thoracic plane(TTP) blocks will be performed by injecting the numbing medicine ropivacaine near the nerves.
Overall Study STARTED	10	9
Overall Study COMPLETED	10	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Local Anesthetic (LA Group) n=10 Participants LA group: In the LA group, only the local anesthetic infiltration will be performed by injecting the numbing medicine ropivacaine into the surgical site.	B Group n=9 Participants B Group: 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 n=19 Participants Total of all reporting groups
Age, Continuous	13.10 years STANDARD_DEVIATION 2.92 • n=10 Participants	8.77 years STANDARD_DEVIATION 3.96 • n=9 Participants	11.05 years STANDARD_DEVIATION 4.02 • n=19 Participants
Sex: Female, Male Female	1 Participants n=10 Participants	5 Participants n=9 Participants	6 Participants n=19 Participants
Sex: Female, Male Male	9 Participants n=10 Participants	4 Participants n=9 Participants	13 Participants n=19 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	10 participants n=10 Participants	9 participants n=9 Participants	19 participants n=19 Participants

PRIMARY outcome

Timeframe: From 24 hours after procedure to 48 hours after procedure

Outcome measures

Outcome measures
Measure	Local Anesthetic (LA Group) n=10 Participants LA group: In the LA group, only the local anesthetic infiltration will be performed by injecting the numbing medicine ropivacaine into the surgical site.	B Group n=9 Participants B Group: 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	0.035 MME per kg Standard Deviation 0.082	0.008 MME per kg Standard Deviation 0.026

PRIMARY outcome

Timeframe: up to 24 hours after procedure

Outcome measures

Outcome measures
Measure	Local Anesthetic (LA Group) n=10 Participants LA group: In the LA group, only the local anesthetic infiltration will be performed by injecting the numbing medicine ropivacaine into the surgical site.	B Group n=9 Participants B Group: 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	0.021 MME per kg Standard Deviation 0.044	0.008 MME per kg Standard Deviation 0.026

SECONDARY outcome

Timeframe: up to 1.5 hours post procedure in post anesthesia care unit (PACU)

Population: Data were not collected for this outcome measure because this assessment was not used in the PACU. The Face, Legs, Activity, Cry, Consolability (FLACC) Pain Assessment Scale was used instead.

VAS pain scale is a range of scores from 0-100. A higher score indicates greater pain intensity.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 24 hours post procedure

Population: Data were not collected from 1 participant in the Local Anesthetic (LA Group) arm because it was not charted by bedside nurse.

VAS pain scale is a range of scores from 0-10. A higher score indicates greater pain intensity.

Outcome measures

Outcome measures
Measure	Local Anesthetic (LA Group) n=9 Participants LA group: In the LA group, only the local anesthetic infiltration will be performed by injecting the numbing medicine ropivacaine into the surgical site.	B Group n=9 Participants B Group: In the B Group,pectoral (PECS) and transversus thoracic plane(TTP) blocks will be performed by injecting the numbing medicine ropivacaine near the nerves.
Pain as Measured by the Visual Analog Scale (VAS) Pain Score	1.33 score on a scale Standard Deviation 2.23	3.44 score on a scale Standard Deviation 3.46

SECONDARY outcome

Timeframe: up to 6 hours post procedure in post anesthesia care unit (PACU)

Population: Data were not collected from 3 participants in the Local Anesthetic (LA Group) arm because it was not charted by bedside nurse. Data were not collected from 1 participant in the B group arm because it was not charted by bedside nurse.

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.