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

Phase 4

Completed

• Conditions: Nerve Block
• Interventions: Procedure: Continuous Infusion; Procedure: Bolus Administered

• Registration Number: NCT01144559
• Lead Sponsor: University of California, San Diego

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 Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-14
• Study First Submitted QC: 2010-06-14
• Study First Posted: 2010-06-15
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-29
• Last Update Posted: 2010-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous Infusion	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.
Bolus Administration	Bolus Administered	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.

Primary Outcome Measures

Name	Time	Method
Quadriceps Femoris Muscle Strength	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.

Secondary Outcome Measures

Name	Time	Method
Muscle Strength	Hour 22	This will be evaluated using a portable isometric force dynamometer to measure the maximum voluntary isometric contraction (MVIC) in a seated position.
Sensory Level	Hour 22	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.

Trial Locations

Locations (1)

UCSD Medical Center, Hillcrest; 🇺🇸 San Diego, California, United States