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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01144559

First Posted: June 15, 2010

Last Update Posted: November 1, 2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

University of California, San Diego

Purpose

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.

Condition	Intervention	Phase
Nerve Block	Procedure: Continuous Infusion Procedure: Bolus Administered	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Continuous Femoral Nerve Blocks: Relative Effects of Basal Infusion and Bolus Doses on Sensory and Motor Function

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:

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.
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.

Secondary Outcome Measures:

Muscle Strength [ Time Frame: Every Hour for 14 hours ]
This will be evaluated using a portable isometric force dynamometer to measure the maximum voluntary isometric contraction (MVIC) in a seated position.
Sensory Level [ Time Frame: Every Hour for 14 hours ]
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.
Muscle Strength [ Time Frame: 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 [ Time Frame: 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.


Estimated Enrollment:	15
Study Start Date:	June 2010
Study Completion Date:	September 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01144559

Locations


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

Sponsors and Collaborators

University of California, San Diego

Investigators


Principal Investigator:	Brian M Ilfeld, M.D., M.S.	University of California, San Diego

More Information


Responsible Party:	Brian M. Ilfeld, M.D., M.S./Principal Investigator, University of California, San Diego, Department of Anesthesiology
ClinicalTrials.gov Identifier:	NCT01144559 History of Changes
Other Study ID Numbers:	Femoral Sensory and Motor
First Submitted:	June 14, 2010
First Posted:	June 15, 2010
Last Update Posted:	November 1, 2010
Last Verified:	October 2010

Keywords provided by University of California, San Diego:


Femoral Nerve Block Bolus Continuous Infusion	UCSD Perineural Catheter Volunteer lower extremity nerve blocks

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