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Continuous Adductor Canal Nerve Blocks: Relative Effects of a Basal Infusion v. Hourly Bolus Doses

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ClinicalTrials.gov Identifier: NCT02219438
Recruitment Status : Completed
First Posted : August 18, 2014
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego

Brief Summary:

Patients usually experience moderate-to-severe pain following the knee replacement that is often treated with a femoral nerve block (injection of numbing medicine placed around the main nerve of the knee joint). To make the nerve block last longer, a tiny tube is often placed next to the nerve and numbing medicine is infused for multiple days. However, while the numbing medicine takes away pain, it also decreases sensations, muscle strength, and proprioception (knowing where the leg is in space without looking at it) which greatly increases the risk of falling. Since falling can be catastrophic following major surgery, a femoral nerve blocks are being phased out by surgeons and anesthesiologists. The most-promising replacement is called an adductor canal nerve block. For this new type of block, a perineural catheter is inserted into a small canal in the middle of the upper leg. This canal contains the sensory nerve fibers leading to the knee, and only a single nerve that serves a relatively small muscle. Multiple studies have demonstrated a dramatic increase in muscle strength using the new adductor canal block compared with the traditional femoral block. However, practitioners perceptions of the new block is that it provides insufficient pain control following knee arthroplasty, even though all of the sensory nerves affected with the femoral block are also-theoretically-affected with the adductor canal block. One reason for this difference may be the small canal of the latter which is a relatively tight area in which the numbing medicine might not spread particularly well (due to pressure from surrounding tissues). One way to possibly counter this issue is by providing repeated boluses of the numbing medicine that will improve the medicine's spread relative to a more-traditional slow, continuous ("basal") infusion. This study seeks to compare these two techniques of medication administration through perineural adductor canal catheters:

Our primary aim is to test the hypothesis that, for continuous adductor canal blocks, providing local anesthetic as repeated, hourly bolus doses results in an increased sensory block compared with providing local anesthetic as a continuous basal infusion at an equivalent hourly dose.

As a secondary aim, we hypothesize that, for continuous adductor canal blocks, providing local anesthetic as repeated, hourly bolus doses results in either equivalent or less motor block compared with providing local anesthetic as a continuous basal infusion at an equivalent hourly dose.


Condition or disease Intervention/treatment Phase
Healthy Human Volunteers Drug: ropivacaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Continuous Adductor Canal Nerve Blocks: Relative Effects of a Basal Infusion v. Hourly Bolus Doses
Study Start Date : August 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bolus
ropivacaine 0.2% administration as repeated, scheduled (one/h) bolus doses (8 mL) x8 h
Drug: ropivacaine
Active Comparator: basal
ropivacaine 0.2% administration as a continuous basal infusion (8 mL/h) x8 h
Drug: ropivacaine



Primary Outcome Measures :
  1. tolerance to cutaneous electrical current [ Time Frame: After 8 h of infusion ]
    Evaluated in the seated position using transcutaneous electrical stimulation (TES) in the same manner as described throughout the anesthesia literature (this is a "gold standard" for regional anesthesia studies). EKG pads will be positioned over the proximal patella and quadriceps tendon 1 cm medial of midline and attached to a nerve stimulator. The current will be increased from 0 mA until the subject reports slight discomfort (or, up to a maximum of 80 mA), at which time the current is recorded as the TES value and the nerve stimulator turned off.


Secondary Outcome Measures :
  1. Tolerance of transcutaneous electrical stimulation [ Time Frame: 0-14, on the hour, plus hour 22 ]
    Evaluated in the seated position using transcutaneous electrical stimulation (TES) in the same manner as described throughout the anesthesia literature (this is a "gold standard" for regional anesthesia studies). EKG pads will be positioned over the proximal patella and quadriceps tendon 1 cm medial of midline and attached to a nerve stimulator. The current will be increased from 0 mA until the subject reports slight discomfort (or, up to a maximum of 80 mA), at which time the current is recorded as the TES value and the nerve stimulator turned off.

  2. Quadriceps femoris muscle strength (maximum voluntary isometric contraction) [ Time Frame: 0-14, on the hour, plus hour 22 ]
    Evaluated using a portable isometric force dynamometer to measure the maximum voluntary isometric contraction (MVIC) in a seated position. The primary end point will be the quadriceps femoris maximum voluntary isometric contraction (MVIC) expressed as a percentage of the pre-ropivacaine (baseline) MVIC: post / pre x 100; with the two sides of each subject compared with each other at Hour 8.



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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; and (2) willing to have bilateral adductor canal perineural catheters placed with subsequent ropivacaine administration and motor/sensory testing for 14 hours, requiring an overnight stay in the UCSD CTRI-CCR 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); and (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): NCT02219438


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
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Responsible Party: Brian M. Ilfeld, MD, MS, Professor of Anesthesiology, In Residence, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02219438    
Other Study ID Numbers: Adductor Canal Basal vs Bolus
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents