Anesthesia, Conduction
Conditions
Keywords
Paravertebral nerve block, Erector Spinae Plane block
Brief summary
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.
Interventions
PROCEDUREErector Spinae Plane Block
Regional anesthesia with injected local anesthetic solution, placed in space underlying erector spinae muscles
PROCEDUREParavertebral Block
Regional anesthesia with injected local anesthetic solution, placed in space adjacent to vertebrae
Sponsors
University of New Mexico
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult female patients having bilateral mastectomy surgery at University of New Mexico Outpatient Surgical and Imaging Services (OSIS) facility * Age \>18 years * Consenting to regional anesthesia for postoperative pain control
Exclusion criteria
* Age \<18 years * Unable to consent * Using anticoagulant medication or have a bleeding disorder * Pregnancy * Inability to speak English for consent process
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin Temperature Increase From Baseline | 30 minutes | Thermography-measured increase in temperature of skin affected by nerve block |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Skin Temperature | 30 minutes | Thermography-measured temperature of skin affected by nerve block |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Erector Spinae Plane Block Regional anesthesia with injected local anesthetic solution, placed in space underlying erector spinae muscles | 8 |
| Erector Spinae Plane Block Regional anesthesia with injected local anesthetic solution, placed in space underlying erector spinae muscles | 8 |
| Paravertebral Block Regional anesthesia with injected local anesthetic solution, placed in space adjacent to vertebrae | 8 |
| Paravertebral Block Regional anesthesia with injected local anesthetic solution, placed in space adjacent to vertebrae | 8 |
| Total | 32 |
Baseline characteristics
| Characteristic | Total | Erector Spinae Plane Block | Paravertebral Block |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Anatomical sides [Right vs Left] | 0 Anatomical sides [Right vs Left] | 0 Anatomical sides [Right vs Left] |
| Age, Categorical >=65 years | 0 Anatomical sides [Right vs Left] | 0 Anatomical sides [Right vs Left] | 0 Anatomical sides [Right vs Left] |
| Age, Categorical Between 18 and 65 years | 16 Anatomical sides [Right vs Left] | 8 Anatomical sides [Right vs Left] | 8 Anatomical sides [Right vs Left] |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment United States | 8 participants | 8 participants | 8 participants |
| Sex: Female, Male Female | 16 Anatomical sides [Right vs Left] | 8 Anatomical sides [Right vs Left] | 8 Anatomical sides [Right vs Left] |
| Sex: Female, Male Male | 0 Anatomical sides [Right vs Left] | 0 Anatomical sides [Right vs Left] | 0 Anatomical sides [Right vs Left] |
| Superficial skin temperature | 88.6 degrees F STANDARD_DEVIATION 1.7 | 88.6 degrees F STANDARD_DEVIATION 1.7 | 88.6 degrees F STANDARD_DEVIATION 1.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
Skin Temperature Increase From Baseline
Thermography-measured increase in temperature of skin affected by nerve block
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erector Spinae Plane Block Side | Skin Temperature Increase From Baseline | 1.9 degrees C | Standard Deviation 0.8 |
| Paravertebral Block Side | Skin Temperature Increase From Baseline | 2.3 degrees C | Standard Deviation 0.9 |
Secondary
Average Skin Temperature
Thermography-measured temperature of skin affected by nerve block
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erector Spinae Plane Block Side | Average Skin Temperature | 33.3 degrees C | Standard Deviation 0.9 |
| Paravertebral Block Side | Average Skin Temperature | 33.7 degrees C | Standard Deviation 0.9 |