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Phase 4 N=24 Randomized Quadruple-blind Treatment

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

Healthy Human Volunteers

Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Tolerance to Cutaneous Electrical Current — 26.6; 27.1 mA

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Bolus (Drug); Basal (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of California, San Diego
Primary completion
Dec 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Tolerance to Cutaneous Electrical Current
26.6; 27.1
SECONDARY
Tolerance to Transcutaneous Electrical Current
26.7; 26.6; 26.8; 24.7; 27.9; 27.4
SECONDARY
Maximum Voluntary Isometric Contraction of the Quadriceps
188; 188; 84; 88; 89; 87

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.

Eligibility 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02219438). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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