Healthy Human Volunteers Clinical Trial
Official title:
Continuous Adductor Canal Nerve Blocks: Relative Effects of a Basal Infusion v. Hourly Bolus Doses
Verified date | March 2021 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
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United States | University California San Diego | San Diego | California |
Lead Sponsor | Collaborator |
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University of California, San Diego |
United States,
Monahan AM, Sztain JF, Khatibi B, Furnish TJ, Jæger P, Sessler DI, Mascha EJ, You J, Wen CH, Nakanote KA, Ilfeld BM. Continuous Adductor Canal Blocks: Does Varying Local Anesthetic Delivery Method (Automatic Repeated Bolus Doses Versus Continuous Basal In — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tolerance to Cutaneous Electrical Current | 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. | After 8 h of infusion | |
Secondary | Tolerance to Transcutaneous Electrical Current | 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. | baseline through Hour 14 (except Hour 8 which is the primary outcome) and then again at Hour 22 | |
Secondary | Maximum Voluntary Isometric Contraction of the Quadriceps | Strength of the quadriceps muscle was assessed by measurement of maximum voluntary isometric contraction. In the sitting position, without using accessory muscle groups, subjects performed maximum forceful knee extension against an electromechanical dynamometer (MicroFET2, Lafayette Instrument Company, Lafeyette, IN). The subject sat at the side of the bed with their legs dangling. The device was placed against the anterior tibia just above the malleoli between the subject and a nonelastic 5 cm-wide fabric band that was affixed to the gurney to stabilize the dynamometer during flexing of the quadriceps femoris muscle. Subjects were instructed to come to maximum force of knee extension over 2 seconds, hold this force for 5 seconds, and then relax. The maximum force was recorded, and results are reported relative to the pre-infusion baseline measurement (i.e., percent of baseline). | Baseline and then every hour through Hour 14, as well as Hour 22 |
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