Nerve Block
Conditions
Keywords
Femoral, Nerve Block, Bolus, Continuous Infusion, UCSD, Perineural Catheter, Volunteer, lower extremity nerve blocks
Brief summary
This is a research study to determine if the way local anesthetic- or numbing medication- is delivered through a tiny tube next to the nerves that go to the thigh affects the strength and sensation in the thigh.
Detailed description
Specific Aim: Research study to test the null hypothesis that differing the delivery method (continuous basal infusion vs. repeated bolus doses) but providing an equal total dose of Ropivacaine has no impact on quadriceps muscle strength. These results will help define the optimal delivery method of local anesthetic used for continuous peripheral nerve blocks and help guide future research in this clinically relevant area.
Interventions
PROCEDUREContinuous Infusion
Extremity randomized continuous infusion will be given a peripheral nerve block and 5cc of Ropivacaine will be administered continuously every hour by a pain pump. Outcome measures will be tested.
PROCEDUREBolus Administered
Extremity randomized continuous infusion will be given a peripheral nerve block and 5cc of Ropivacaine will be administered using a bolus every hour by a pain pump. Outcome measures will be tested.
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age or older * willing to have bilateral femoral perineural catheters place with a subsequent ropivacaine infusion and motor/sensory testing for 9 hours * willing to stay overnight in the UCSD GCRC/CTRI to allow dissipation of local anesthetic infusion effects by the following morning.
Exclusion criteria
* current daily analgesic use * opioid use with in the previous 4 weeks * any neuro-muscular deficit of either femoral nerves and/or quadriceps muscles * pregnancy * incarceration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quadriceps Femoris Muscle Strength | Every Hour for 14 hours | The primary end point will be the quadriceps femoris maximum voluntary isometric contraction (MVIC) expressed as percentage of the pre-ropivacaine MVIC: post/pre x 100; with the two sides of each subject compared with each other. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Strength | Every Hour for 14 hours | This will be evaluated using a portable isometric force dynamometer to measure the maximum voluntary isometric contraction (MVIC) in a seated position. |
| Sensory Level | Every Hour for 14 hours | Evaluated in the seated position, using Transcutaneous Electrical Stimulation (TES)in the same manner as outlined in the current anesthesia literature. The current will be increased from 0mA until the subject identifies sensation at which time the current is recorded as the TES value and the nerve stimulator is turned off. |
Countries
United States
Outcome results
None listed