Continuous Femoral Nerve Blocks: Relative Effects of Basal Infusion and Bolus Doses on Sensory and Motor Function

University of California, San Diego15 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Nerve Block

Interventions

Continuous InfusionPROCEDURE

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.

Bolus AdministeredPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

UCSD Medical Center, Hillcrest

San Diego, California, United States

Outcomes

Primary Outcomes

Quadriceps Femoris Muscle Strength

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.

Time frame: Every Hour for 14 hours

Quadriceps Femoris Muscle Strength

Time frame: Hour 22

Secondary Outcomes

Muscle Strength

This will be evaluated using a portable isometric force dynamometer to measure the maximum voluntary isometric contraction (MVIC) in a seated position.

Time frame: Every Hour for 14 hours

Sensory Level

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.

Time frame: Every Hour for 14 hours

Muscle Strength

This will be evaluated using a portable isometric force dynamometer to measure the maximum voluntary isometric contraction (MVIC) in a seated position.

Time frame: Hour 22

Sensory Level

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.