Overview

Optimizing Local Anesthetic Concentration for Continuous Popliteal-Sciatic Nerve Blocks

Status:
Completed
Trial end date:
2013-11-01
Target enrollment:
0
Participant gender:
All
Summary
A continuous peripheral nerve block-also termed "perineural local anesthetic infusion"-involves the insertion of a tiny tube (a "catheter") through the skin and adjacent to a peripheral nerve, followed by local anesthetic (numbing medicine) administration via the catheter, providing pain control following surgery. Continuous peripheral nerve blocks may be provided in the hospital setting, but the use of lightweight, portable pumps permits infusion at home as well. However, it remains unknown if the concentration of the local anesthetic influences the block effects; or, is it rather simply the total dose of medication that is important. If it is the latter, then the concentration of local anesthetic could be increased, allowing a decreased basal infusion rate, which would allow patients at home to receive twice the duration of potent pain control since their infusion pump local anesthetic reservoir would last twice as long as current practice. In addition, if one concentration/dose combination results in less muscle weakness, but with at least equivalent analgesia, then the risk of falling might be decreased as well. The investigators will test the hypothesis that providing ropivacaine at different concentrations and rates (0.1% at 8 mL/hour vs. 0.4% at 2 mL/hour)-but at an equivalent total basal (8 mg/hour)-produces comparable effects when used in a continuous popliteal-sciatic nerve block.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of California, San Diego
Collaborators:
Baxter Healthcare Corporation
Baxter Healthcare International
Treatments:
Anesthetics
Anesthetics, Local
Ropivacaine
Criteria
Inclusion Criteria:

1. age ≥ 18 years

2. willing to have bilateral femoral perineural catheters placed with a subsequent
ropivacaine infusion and motor/sensory testing for 6 hours, requiring an overnight
stay in the UCSD GCRC/CTRI to allow dissipation of local anesthetic infusion effects
by the following morning

Exclusion Criteria:

1. current daily analgesic use

2. opioid use within the previous 4 weeks

3. any neuro-muscular deficit of either femoral nerves and/or quadriceps muscles

4. morbid obesity [weight > 35 kg/m2]

5. pregnancy (as determined by a urine pregnancy test prior to any study interventions)

6. incarceration

We expect to recruit a maximum of 30 healthy volunteers; with a target goal of 24 for the
analysis. Selection for inclusion will not be based on gender, race, or socioeconomic
status. The study population of interest includes men and women of all races and
socioeconomic status. There will be no participants from vulnerable populations, such as
pregnant women, children, or prisoners.