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

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.

Study Overview

• Status: Completed
• Conditions: Nerve Block
• Intervention / Treatment: Procedure: Continuous Infusion; Procedure: Bolus Administered

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 Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • UCSD Medical Center, Hillcrest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Procedure: Continuous 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.
ACTIVE_COMPARATOR: 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.	Procedure: Bolus 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Every Hour for 14 hours
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.	Hour 22

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Strength	This will be evaluated using a portable isometric force dynamometer to measure the maximum voluntary isometric contraction (MVIC) in a seated position.	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.	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.	Hour 22
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.	Hour 22

Collaborators and Investigators

• Sponsor: University of California, San Diego

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (ACTUAL): September 1, 2010
• Study Completion (ACTUAL): September 1, 2010

Study Registration Dates

• First Submitted: June 14, 2010
• First Submitted That Met QC Criteria: June 14, 2010
• First Posted (ESTIMATE): June 15, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): November 1, 2010
• Last Update Submitted That Met QC Criteria: October 29, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: Nerve Block; Volunteer; Bolus; Femoral; UCSD; Continuous Infusion; Perineural Catheter; lower extremity nerve blocks
• Other Study ID Numbers: Femoral Sensory and Motor