Overview
Continuous Erector Spinae Plane Blocks for Rib Fractures
Status:
Recruiting
Recruiting
Trial end date:
2023-12-01
2023-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of California, San DiegoTreatments:
Ropivacaine
Criteria
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).