Continuous Erector Spinae Plane Blocks for Rib Fractures
Condition: Rib Fractures; Trauma; Anesthesia; Anesthesia, Local
MeSH terms: Fractures, Bone; Rib Fractures
Intervention: Active ropivacaine 0.3% erector spinae plane perineural administration; Placebo erector spinae plane perineural administration
Intervention description: Ropivacaine 0.3% administration via an erector spinae plane perineural catheter; Normal saline administration via an erector spinae plane perineural catheter
Intervention MeSH terms: Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-masked, placebo-controlled, parallel group clinical study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Study solution containing either local anesthetic (ropivacaine) or saline will be prepared by the UCSD Investigational Drug Study Service. Both ropivacaine and normal saline are clear and indistinguishable visually.
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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).