Continuous Femoral Nerve Blocks: Relative Effects of Basal Infusion and Bolus Doses on Sensory and Motor Function
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Quadriceps Femoris Muscle Strength
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Continuous Infusion
Each subject will have one lower extremity (Right or Left) randomized to receive a perineural catheter with a continuous infusion of local anesthetic and then the outcomes will be measured.
Intervention: Continuous Infusion (Procedure)
Bolus Administration
The opposite lower extremity (right or left) will be randomized to receive a perineural catheter with the local anesthetic being delivered via a bolus as opposed to continuous as is the case with their other extremity. The outcome measures will then be assessed as described.
Intervention: Bolus Administered (Procedure)
Outcomes
Primary Outcomes
Quadriceps Femoris Muscle Strength
Time Frame: Hour 22
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.
Quadriceps Femoris Muscle Strength
Time Frame: 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 Outcomes
- Muscle Strength(Hour 22)
- Sensory Level(Hour 22)
- Muscle Strength(Every Hour for 14 hours)
- Sensory Level(Every Hour for 14 hours)