CREST Syndrome, Peripheral Vascular Disease, Raynaud Disease, Scleroderma, Diffuse
Conditions
Brief summary
The purpose of this study is to investigate whether the use of the study drug (Exparel) is safe and effective for treating circulation problems and pain in the hand or fingers.
Interventions
DRUGliposomal bupivacaine
injected as an axillary block
Sponsors
Jose Soberon, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) status I-IV
Exclusion criteria
* True Allergy, not sensitivity to: local anesthetics, midazolam, fentanyl, propofol, ketamine * Previous surgery or significant trauma involving the radial or ulnar arteries (previous history of angiography and intravascular catheter placement are permitted) * Pregnancy * Severe hepatic impairment * Evidence of infection at or near the proposed needle insertion site * Any sensorimotor deficit of the ipsilateral upper extremity, whether acute or chronic as determined by the PI and/or designee
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radial and Ulnar Arterial Diameter | 1 hour | Radial and ulnar artery diameter was measured at baseline and 60 min after with a Doppler ultrasound system. A marker was used to indicate the site of initial transducer placement on the forearm to ensure that subsequent scans were performed at the same location. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Measured by Numerical Rating Scale | 1 month | Numerical rating scale pain scores range from 0 (absence of pain) to 10 (worst pain imaginable) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exparel 20 mL liposomal bupivacaine injected once
liposomal bupivacaine: injected as an axillary block | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Exparel | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 13 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 13 Participants | — |
| Sex: Female, Male Female | 10 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
Radial and Ulnar Arterial Diameter
Radial and ulnar artery diameter was measured at baseline and 60 min after with a Doppler ultrasound system. A marker was used to indicate the site of initial transducer placement on the forearm to ensure that subsequent scans were performed at the same location.
Time frame: 1 hour
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Pre-block (Baseline) | Radial and Ulnar Arterial Diameter | Ulnar artery diameter | 0.16 centimeters |
| Pre-block (Baseline) | Radial and Ulnar Arterial Diameter | Radial artery diameter | 0.19 centimeters |
| One Hour Post Block | Radial and Ulnar Arterial Diameter | Ulnar artery diameter | .20 centimeters |
| One Hour Post Block | Radial and Ulnar Arterial Diameter | Radial artery diameter | 0.23 centimeters |
Secondary
Pain Measured by Numerical Rating Scale
Numerical rating scale pain scores range from 0 (absence of pain) to 10 (worst pain imaginable)
Time frame: 1 month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pre-block (Baseline) | Pain Measured by Numerical Rating Scale | 6.0 units on a scale |
| One Hour Post Block | Pain Measured by Numerical Rating Scale | 5.2 units on a scale |