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

University of California San Diego logo

University of California San Diego

Status and phase

Completed
Phase 4

Conditions

Nerve Block

Treatments

Procedure: Bolus Administered
Procedure: Continuous Infusion

Study type

Interventional

Funder types

Other

Identifiers

NCT01144559
Femoral Sensory and Motor

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

15 participants in 2 patient groups

Continuous Infusion
Active Comparator group
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.
Treatment:
Procedure: Continuous Infusion
Bolus Administration
Active Comparator group
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.
Treatment:
Procedure: Bolus Administered

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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