Trial Outcomes & Findings for Thermal-Imaging Comparison of Nerve Blocks for Bilateral Mastectomy (NCT NCT04928794)
NCT ID: NCT04928794
Last Updated: 2024-10-21
Results Overview
Thermography-measured increase in temperature of skin affected by nerve block
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
30 minutes
Results posted on
2024-10-21
Participant Flow
Unit of analysis: Anatomical side (Right vs Left)
Participant milestones
| Measure |
Erector Spinae Plane Block
Regional anesthesia with injected local anesthetic solution, placed in space underlying erector spinae muscles
|
Paravertebral Block
Regional anesthesia with injected local anesthetic solution, placed in space adjacent to vertebrae
|
|---|---|---|
|
Overall Study
STARTED
|
8 8
|
8 8
|
|
Overall Study
COMPLETED
|
8 8
|
8 8
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Erector Spinae Plane Block
n=8 Anatomical sides [Right vs Left]
Regional anesthesia with injected local anesthetic solution, placed in space underlying erector spinae muscles
|
Paravertebral Block
n=8 Anatomical sides [Right vs Left]
Regional anesthesia with injected local anesthetic solution, placed in space adjacent to vertebrae
|
Total
n=16 Anatomical sides [Right vs Left]
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Anatomical sides [Right vs Left]
n=8 Anatomical sides [Right vs Left]
|
0 Anatomical sides [Right vs Left]
n=8 Anatomical sides [Right vs Left]
|
0 Anatomical sides [Right vs Left]
n=16 Anatomical sides [Right vs Left]
|
|
Age, Categorical
Between 18 and 65 years
|
8 Anatomical sides [Right vs Left]
n=8 Anatomical sides [Right vs Left]
|
8 Anatomical sides [Right vs Left]
n=8 Anatomical sides [Right vs Left]
|
16 Anatomical sides [Right vs Left]
n=16 Anatomical sides [Right vs Left]
|
|
Age, Categorical
>=65 years
|
0 Anatomical sides [Right vs Left]
n=8 Anatomical sides [Right vs Left]
|
0 Anatomical sides [Right vs Left]
n=8 Anatomical sides [Right vs Left]
|
0 Anatomical sides [Right vs Left]
n=16 Anatomical sides [Right vs Left]
|
|
Sex: Female, Male
Female
|
8 Anatomical sides [Right vs Left]
n=8 Anatomical sides [Right vs Left]
|
8 Anatomical sides [Right vs Left]
n=8 Anatomical sides [Right vs Left]
|
16 Anatomical sides [Right vs Left]
n=16 Anatomical sides [Right vs Left]
|
|
Sex: Female, Male
Male
|
0 Anatomical sides [Right vs Left]
n=8 Anatomical sides [Right vs Left]
|
0 Anatomical sides [Right vs Left]
n=8 Anatomical sides [Right vs Left]
|
0 Anatomical sides [Right vs Left]
n=16 Anatomical sides [Right vs Left]
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
8 participants
n=8 Participants
|
8 participants
n=8 Participants
|
8 participants
n=8 Participants
|
|
Superficial skin temperature
|
88.6 degrees F
STANDARD_DEVIATION 1.7 • n=8 Participants
|
88.6 degrees F
STANDARD_DEVIATION 1.7 • n=8 Participants
|
88.6 degrees F
STANDARD_DEVIATION 1.7 • n=8 Participants
|
PRIMARY outcome
Timeframe: 30 minutesThermography-measured increase in temperature of skin affected by nerve block
Outcome measures
| Measure |
Erector Spinae Plane Block Side
n=8 Participants
Side of body with Erector Spinae Plane Block
|
Paravertebral Block Side
n=8 Participants
Side of body with Paravertebral Block
|
|---|---|---|
|
Skin Temperature Increase From Baseline
|
1.9 degrees C
Standard Deviation 0.8
|
2.3 degrees C
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 30 minutesThermography-measured temperature of skin affected by nerve block
Outcome measures
| Measure |
Erector Spinae Plane Block Side
n=8 Participants
Side of body with Erector Spinae Plane Block
|
Paravertebral Block Side
n=8 Participants
Side of body with Paravertebral Block
|
|---|---|---|
|
Average Skin Temperature
|
33.3 degrees C
Standard Deviation 0.9
|
33.7 degrees C
Standard Deviation 0.9
|
Adverse Events
Erector Spinae Plane Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Paravertebral Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Anesthesiology Research Director
Anesthesiology Department, University of New Mexico
Phone: 505-272-2610
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place