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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Infusion | Active Comparator | 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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| Bolus Administration | Active Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Infusion | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian M Ilfeld, M.D., M.S. | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Medical Center, Hillcrest | San Diego | California | 92103 | United States |
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| Bolus Administered | Procedure | 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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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 |