Finger Injuries, Hand Injuries, Wrist Injuries
Conditions
Keywords
hand surgery, wrist surgery, finger surgery, anesthesia, regional anesthesia, postoperative pain
Brief summary
The purpose of this study is to compare Exparel, a new, long-lasting numbing medication and a shorter-acting nerve block to a traditional single-shot nerve block in patients having hand, wrist or finger surgery.
Interventions
DRUGExparel Forearm block
20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block.
DRUGBupivacaine supraclavicular block
20-30mL 0.5% bupivacaine
Sponsors
Pacira Pharmaceuticals, Inc
Jose Soberon, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* patients 18 years or older having hand, wrist, or finger surgery * ability to understand and provide informed consent * American Society of Anesthesiologists status I-III * presence of a responsible adult caregiver for 48-72 hours after surgery
Exclusion criteria
* patient refusal or inability to provide informed consent * true allergy, not sensitivity to local anesthetics, midazolam, fentanyl, hydromorphone, propofol * pregnancy * hepatic or renal failure * evidence of infection at or near the proposed needle insertion site * any sensorimotor deficit of the upper extremity * BMI greater than or equal to 35 * uncontrolled or severe pulmonary disease * anticoagulant use (not aspirin or non-steroidal anti-inflammatories) * chronic pain patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Onset of Sensorimotor Block | 30 minutes | A blinded study staff member will evaluate the subject after the block is performed. Subjects will be asked to move their hand and will be asked if they can feel a sharp sensation on specific areas of their hand. Once no movement and no feeling is detected, the block is considered successful and the time will be noted. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exparel Forearm Block Under ultrasound guidance, 3-5 mL Exparel will be injected around the 3 nerves of the forearm prior to surgery. 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block.
Exparel Forearm block: 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block. | 16 |
| Bupivacaine Supraclavicular Block Under ultrasound guidance, 20-30 mL 0.5% Bupivacaine will be used for the supraclavicular block.
Bupivacaine supraclavicular block: 20-30mL 0.5% bupivacaine | 21 |
| Total | 37 |
Baseline characteristics
| Characteristic | Bupivacaine Supraclavicular Block | Total | Exparel Forearm Block |
|---|---|---|---|
| Age, Continuous | 62.5 years STANDARD_DEVIATION 0 | 62.5 years STANDARD_DEVIATION 0 | 62.4 years STANDARD_DEVIATION 0 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 21 participants | 37 participants | 16 participants |
| Sex: Female, Male Female | 17 Participants | 29 Participants | 12 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 21 |
| serious Total, serious adverse events | 0 / 16 | 0 / 21 |
Outcome results
Primary
Onset of Sensorimotor Block
A blinded study staff member will evaluate the subject after the block is performed. Subjects will be asked to move their hand and will be asked if they can feel a sharp sensation on specific areas of their hand. Once no movement and no feeling is detected, the block is considered successful and the time will be noted.
Time frame: 30 minutes
Population: Discrepancies are due to a subset of subjects not achieving full blockade at 30 minutes.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exparel Forearm Block | Onset of Sensorimotor Block | Median nerve block after 30 minutes | 1.0 proportion of subjects |
| Exparel Forearm Block | Onset of Sensorimotor Block | Ulnar nerve block after 30 minutes | .933 proportion of subjects |
| Exparel Forearm Block | Onset of Sensorimotor Block | Radial nerve block after 30 minutes | 1.0 proportion of subjects |
| Exparel Forearm Block | Onset of Sensorimotor Block | Musculocutaneous nerve block after 30 minutes | .933 proportion of subjects |
| Bupivacaine Supraclavicular Block | Onset of Sensorimotor Block | Musculocutaneous nerve block after 30 minutes | .79 proportion of subjects |
| Bupivacaine Supraclavicular Block | Onset of Sensorimotor Block | Median nerve block after 30 minutes | .81 proportion of subjects |
| Bupivacaine Supraclavicular Block | Onset of Sensorimotor Block | Radial nerve block after 30 minutes | .864 proportion of subjects |
| Bupivacaine Supraclavicular Block | Onset of Sensorimotor Block | Ulnar nerve block after 30 minutes | .818 proportion of subjects |