Continuous Femoral Nerve Blocks: Relative Effects of Basal Infusion and Bolus Doses on Sensory and Motor Function
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ClinicalTrials.gov Identifier: NCT01144559 |
Recruitment Status
:
Completed
First Posted
: June 15, 2010
Last Update Posted
: November 1, 2010
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Condition or disease | Intervention/treatment | Phase |
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Nerve Block | Procedure: Continuous Infusion Procedure: Bolus Administered | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 15 participants |
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 |
Study Start Date : | June 2010 |
Actual Primary Completion Date : | September 2010 |
Actual Study Completion Date : | September 2010 |
Arm | Intervention/treatment |
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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.
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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.
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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.
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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.
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- 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.
- 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.

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

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
United States, California | |
UCSD Medical Center, Hillcrest | |
San Diego, California, United States, 92103 |
Principal Investigator: | Brian M Ilfeld, M.D., M.S. | University of California, San Diego |
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 Posted: | June 15, 2010 Key Record Dates |
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 |