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Optimizing Local Anesthetic Concentration for Continuous Popliteal-Sciatic Nerve Blocks

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ClinicalTrials.gov Identifier: NCT01898689
Recruitment Status : Completed
First Posted : July 12, 2013
Last Update Posted : November 6, 2013
Sponsor:
Collaborator:
Baxter Healthcare International
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego

Brief Summary:

A continuous peripheral nerve block-also termed "perineural local anesthetic infusion"-involves the insertion of a tiny tube (a "catheter") through the skin and adjacent to a peripheral nerve, followed by local anesthetic (numbing medicine) administration via the catheter, providing pain control following surgery. Continuous peripheral nerve blocks may be provided in the hospital setting, but the use of lightweight, portable pumps permits infusion at home as well. However, it remains unknown if the concentration of the local anesthetic influences the block effects; or, is it rather simply the total dose of medication that is important. If it is the latter, then the concentration of local anesthetic could be increased, allowing a decreased basal infusion rate, which would allow patients at home to receive twice the duration of potent pain control since their infusion pump local anesthetic reservoir would last twice as long as current practice. In addition, if one concentration/dose combination results in less muscle weakness, but with at least equivalent analgesia, then the risk of falling might be decreased as well.

The investigators will test the hypothesis that providing ropivacaine at different concentrations and rates (0.1% at 8 mL/hour vs. 0.4% at 2 mL/hour)-but at an equivalent total basal (8 mg/hour)-produces comparable effects when used in a continuous popliteal-sciatic nerve block.


Condition or disease Intervention/treatment Phase
Relatively Healthy Volunteers Drug: perineural infusion Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Local Anesthetic Concentration for Continuous Popliteal-Sciatic Nerve Blocks
Study Start Date : July 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Arm Intervention/treatment
Experimental: Ropivacaine 0.1%
Ropivacaine 0.1% at 8 mL/h basal for 6 hours
Drug: perineural infusion
A continuous peripheral nerve block-also termed "perineural local anesthetic infusion"-involves the insertion of a tiny tube (a "catheter") through the skin and adjacent to a peripheral nerve, followed by local anesthetic (numbing medicine) administration via the catheter, providing pain control following surgery. Continuous peripheral nerve blocks may be provided in the hospital setting, but the use of lightweight, portable pumps permits infusion at home as well.
Other Name: continuous peripheral nerve block

Active Comparator: Ropivacaine 0.4%
Ropivacaine 0.4% at 2 mL/h basal for 6 hours
Drug: perineural infusion
A continuous peripheral nerve block-also termed "perineural local anesthetic infusion"-involves the insertion of a tiny tube (a "catheter") through the skin and adjacent to a peripheral nerve, followed by local anesthetic (numbing medicine) administration via the catheter, providing pain control following surgery. Continuous peripheral nerve blocks may be provided in the hospital setting, but the use of lightweight, portable pumps permits infusion at home as well.
Other Name: continuous peripheral nerve block




Primary Outcome Measures :
  1. maximum tolerance to transcutaneous electrical stimulation [ Time Frame: Hour 6 ]
    Sensory perception-depth of analgesia-will be evaluated using tolerance of transcutaneous electrical stimulation with the same quantitative procedure validated and used in multiple clinical trials. Electrocardiogram pads are placed on the lateral aspect of the plantar surface of the foot which is covered by the sciatic nerve distribution; and, the tolerance to cutaneous electrical current is obtained using a nerve stimulator. The current is increased from 0 mA until subjects detect the electrical current (up to a maximum of 80 mA), at which time the current is recorded and the nerve stimulator turned off.


Secondary Outcome Measures :
  1. Tolerance of transcutaneous electrical stimulation [ Time Frame: Hours 0-22, other than Hour 6 (primary endpoint) ]
    Sensory perception-depth of analgesia-will be evaluated using tolerance of transcutaneous electrical stimulation with the same quantitative procedure validated and used in multiple clinical trials. Electrocardiogram pads are placed on the lateral aspect of the plantar surface of the foot which is covered by the sciatic nerve distribution; and, the tolerance to cutaneous electrical current is obtained using a nerve stimulator. The current is increased from 0 mA until subjects detect the electrical current (up to a maximum of 80 mA), at which time the current is recorded and the nerve stimulator turned off.

  2. Muscle strength [ Time Frame: Hours 0-22 ]
    We will evaluate muscle strength with an isometric force electromechanical dynamometer to measure the force produced during a maximum voluntary isometric plantar-flexion (muscles innervated by the sciatic nerve). The dynamometer will be placed against the bed's foot board (immobile) and the subject will be asked to take 2 seconds to come to maximum effort contracting the target muscles, maintain this effort for 5 seconds, and then relax. The measurements immediately prior to perineural ropivacaine administration will be designated as baseline measurements, and all subsequent measurements will be expressed as a percentage of the pre-infusion baseline.



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

Inclusion Criteria:

  1. age ≥ 18 years
  2. willing to have bilateral femoral perineural catheters placed with a subsequent ropivacaine infusion and motor/sensory testing for 6 hours, requiring an overnight stay in the UCSD GCRC/CTRI to allow dissipation of local anesthetic infusion effects by the following morning

Exclusion Criteria:

  1. current daily analgesic use
  2. opioid use within the previous 4 weeks
  3. any neuro-muscular deficit of either femoral nerves and/or quadriceps muscles
  4. morbid obesity [weight > 35 kg/m2]
  5. pregnancy (as determined by a urine pregnancy test prior to any study interventions)
  6. incarceration

We expect to recruit a maximum of 30 healthy volunteers; with a target goal of 24 for the analysis. Selection for inclusion will not be based on gender, race, or socioeconomic status. The study population of interest includes men and women of all races and socioeconomic status. There will be no participants from vulnerable populations, such as pregnant women, children, or prisoners.


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): NCT01898689


Locations
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United States, California
University California San Diego
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Baxter Healthcare International
Investigators
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Principal Investigator: Brian M Ilfeld, MD, MS University California San Diego
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Brian M. Ilfeld, MD, MS, Professor of Anesthesiology, In Residence, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01898689    
Other Study ID Numbers: Baxter Popliteal Volunteer
First Posted: July 12, 2013    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: November 2013