Anesthesia Clinical Trial
Official title:
Continuous Erector Spinae Plane Blocks for Analgesia and Improving Incentive Spirometry Following Traumatic Rib Fractures
Verified date | May 2023 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Rib fractures are one of the most common injuries in trauma patients. These fractures are associated with significant pain as well as decreased ability to inspire deeply or cough to clear secretions, which together lead to complications of the lungs and breathing which leads to risks of further injury and even death. One recent study found that the ability to move air into and out of the lungs practically doubled with the administration of a single-injection Erector Spainae Plane Block (ESPB) while pain levels nearly halved. However, a single-injection nerve block lasts less than 24 hours while a perineural local anesthetic infusion (also termed a "continuous peripheral nerve block") may be administered for multiple days. This entails inserting a tiny tube through the skin and into the area around the nerves, after which more local anesthetic may be administered prolonging the numbing effects. The possibility of extending the duration of a ESPB with local anesthetic administration via a perineural catheter has not be investigated. We therefore are conducting a randomized, triple-masked, placebo-controlled, parallel-arm study to investigate the addition of a continuous ESPB to a single-injection ESPB following traumatic rib fractures. The primary outcome of this study will be the maximum inspired volume measured by incentive spirometry on the afternoon following the nerve block procedure. We hypothesize that the maximum inspired volume will be significantly increased in the afternoon following the procedure with the addition of a continuous ESPB to a single-injection ESPB.
Status | Terminated |
Enrollment | 4 |
Est. completion date | March 24, 2023 |
Est. primary completion date | March 26, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - having a total of 1-6 rib fractures at least 3 cm distal to the costo-transverse joint (bilateral fractures are acceptable, but the total of the two sides combined must not exceed 6 fractures) - regional anesthetic requested by the admitting service - patient accepting of a perineural catheter insertion and subsequent study fluid treatment. Exclusion Criteria: - chronic opioid use (daily use within the 2 weeks prior to presentation and duration of use > 4 weeks; of note, any testing for opioid use will not occur as part of the study, but may as standard of care) - pregnancy - incarceration - inability to communicate with the investigators - weight < 45 kg or morbid obesity (body mass index > 40 kg/m2) - comorbidity precluding either perineural catheter insertion or subsequent ambulatory perineural local anesthetic administration (e.g., current infection at the catheter insertion site, known hepatic or renal insufficiency, immune-compromised status of any etiology) - any patient unable to correctly perform incentive spirometry as this is the primary outcome measure - any patient with any degree of decreased mental capacity as determined by the surgical service - any reason an investigator believes study participation would not be in the best interest of the potential subject - flail chest - chest tube - fracture of the 1st rib on either side - any injury other than the rib fracture(s) that potentially effects inspiratory effort or volume (e.g., clavicle fracture) - inability to contact the investigators during the perineural administration, and vice versa (e.g., lack of telephone access). |
Country | Name | City | State |
---|---|---|---|
United States | University California San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximal Inspired Volume - Absolute | Measured via a handheld incentive spirometer. The best of three measurements will be recorded as the maximum inspired volume. | Between 1200 and 1700 on the day following the procedure | |
Secondary | Maximal Inspired Volume - Absolute | Measured via a handheld incentive spirometer. The best of three measurements will be recorded as the maximum inspired volume. | Afternoons on postoperative days 2 and 7, postoperative months 0.5, 1, 1.5, 2, 3, 6, and 12 | |
Secondary | Maximal Inspired Volume - Percentage Change From Baseline Prior to Intervention | Measured via a handheld incentive spirometer. The best of three measurements will be recorded as the maximum inspired volume. | Afternoons on postoperative days 1, 2 and 7, postoperative months 0.5, 1, 1.5, 2, 3, 6, and 12 | |
Secondary | Brief Pain Inventory (Short Form, Interference Subscale) | The Brief Pain Inventory (short form, Interference scale) is an instrument specifically designed to assess pain and its impact on physical and emotional functioning [7 questions related specifically to rib fracture pain and not other injuries]. We calculated the total score of the 7 questions combined. The minimum is zero (no interference, better outcome) and the maximum is 70 (maximum interference, worse outcome). | Months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure | |
Secondary | Rib Fracture Pain When Using an Incentive Spirometer | Pain rated from 0-10 using a Numeric Rating Scale with 0 equivalent to no pain and 10 equivalent to the worst imaginable pain | Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure | |
Secondary | WORST Rib Fracture Pain in Previous 24 Hours | Pain rated from 0-10 using a Numeric Rating Scale with 0 equivalent to no pain and 10 equivalent to the worst imaginable pain | Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure | |
Secondary | AVERAGE Rib Fracture Pain in Previous 24 Hours | Pain rated from 0-10 using a Numeric Rating Scale with 0 equivalent to no pain and 10 equivalent to the worst imaginable pain | Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure | |
Secondary | LEAST Rib Fracture Pain in Previous 24 Hours | Pain rated from 0-10 using a Numeric Rating Scale with 0 equivalent to no pain and 10 equivalent to the worst imaginable pain | Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure | |
Secondary | CURRENT Rib Fracture Pain in Previous 24 Hours | Pain rated from 0-10 using a Numeric Rating Scale with 0 equivalent to no pain and 10 equivalent to the worst imaginable pain | Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure | |
Secondary | Opioid Consumption | Amount of opioid used in last 24 hours (ultimately measured in morphine equivalents) | Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure | |
Secondary | Sleep Disturbances Due to Rib Fracture Pain | Number of awakenings due to rib fracture pain the previous night | Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure |
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