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This is a one-armed trial of two regional anesthesia (peripheral nerve block) techniques to provide postoperative analgesia after bilateral mastectomy. The two techniques are paravertebral block and erector spinae plane (ESP) block. Patients will serve as their own controls, with one block technique applied on one side of the body and the other technique contralaterally. Anatomical distribution of block effectiveness will be assessed with thermal imaging, and this distribution will be visually compared between the two techniques.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peripheral Nerve Block with 2 Techniques | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erector Spinae Plane Block | Procedure | Regional anesthesia with injected local anesthetic solution, placed in space underlying erector spinae muscles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Skin Temperature Increase From Baseline | Thermography-measured increase in temperature of skin affected by nerve block | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Average Skin Temperature | Thermography-measured temperature of skin affected by nerve block | 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Billstrand, MD | University of New Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico Outpatient Surgical and Imaging Services | Albuquerque | New Mexico | 87102 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Erector Spinae Plane Block | Regional anesthesia with injected local anesthetic solution, placed in space underlying erector spinae muscles |
| FG001 | Paravertebral Block | Regional anesthesia with injected local anesthetic solution, placed in space adjacent to vertebrae |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Erector Spinae Plane Block | Regional anesthesia with injected local anesthetic solution, placed in space underlying erector spinae muscles |
| BG001 | Paravertebral Block | Regional anesthesia with injected local anesthetic solution, placed in space adjacent to vertebrae |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Units |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Skin Temperature Increase From Baseline | Thermography-measured increase in temperature of skin affected by nerve block | Posted | Mean | Standard Deviation | degrees C | 30 minutes |
|
|
One day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Erector Spinae Plane Block | Regional anesthesia with injected local anesthetic solution, placed in space underlying erector spinae muscles |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anesthesiology Research Director | Anesthesiology Department, University of New Mexico | 505-272-2610 | HSC-Anesthesiology@salud.unm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 17, 2021 | Dec 19, 2023 | Prot_SAP_000.pdf |
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| Paravertebral Block | Procedure | Regional anesthesia with injected local anesthetic solution, placed in space adjacent to vertebrae |
|
| BG002 | Total | Total of all reporting groups |
| Anatomical sides [Right vs Left] |
|
| Anatomical sides [Right vs Left] |
| Anatomical sides [Right vs Left] |
|
|
| Sex: Female, Male | Count of Units | Anatomical sides [Right vs Left] | Anatomical sides [Right vs Left] |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
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| Region of Enrollment | Number | participants | Participants |
|
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| Superficial skin temperature | Mean | Standard Deviation | degrees F | Participants |
|
|
| Participants |
|
|
| Secondary | Average Skin Temperature | Thermography-measured temperature of skin affected by nerve block | Posted | Mean | Standard Deviation | degrees C | 30 minutes |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Paravertebral Block | :Regional anesthesia with injected local anesthetic solution, placed in space adjacent to vertebrae | 0 | 8 | 0 | 8 | 0 | 8 |
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