Expired Study
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San Diego, California 92103


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.


Study summary:

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.


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


Study is Available At:


Original ID:

Femoral Sensory and Motor


NCT ID:

NCT01144559


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, San Diego


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

15


Enrollment Type:

Anticipated


Overall Contact Information

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

Study Dates

Start Date:June 2010
Completion Date:September 2010
Completion Type:Actual
Primary Completion Date:September 2010
Primary Completion Type:Actual
Verification Date:October 2010
Last Changed Date:October 29, 2010
First Received Date:June 14, 2010

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Sensory Level
Time Frame:Hour 22
Safety Issues:False
Description: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 curren
Outcome Type:Secondary Outcome
Measure:Muscle Strength
Time Frame:Hour 22
Safety Issues:False
Description:This will be evaluated using a portable isometric force dynamometer to measure the maximum voluntary isometric contraction (MVIC) in a seated position.
Outcome Type:Secondary Outcome
Measure:Sensory Level
Time Frame:Every Hour for 14 hours
Safety Issues:False
Description: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 curren
Outcome Type:Secondary Outcome
Measure:Muscle Strength
Time Frame:Every Hour for 14 hours
Safety Issues:False
Description:This will be evaluated using a portable isometric force dynamometer to measure the maximum voluntary isometric contraction (MVIC) in a seated position.
Outcome Type:Primary Outcome
Measure:Quadriceps Femoris Muscle Strength
Time Frame:Hour 22
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:Quadriceps Femoris Muscle Strength
Time Frame:Every Hour for 14 hours
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Procedure
Name:Continuous Infusion
Description: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.
Arm Name:Continuous Infusion
Intervention Type:Procedure
Name:Bolus Administered
Description: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.
Arm Name:Bolus Administration

Study Arms

Study Arm Type:Active Comparator
Arm Name:Bolus Administration
Description: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.
Study Arm Type:Active Comparator
Arm Name:Continuous Infusion
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, San Diego

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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