Bilateral Continuous Erector Spinae Blocks for Post-Sternotomy Pain Management
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the efficacy of bilateral continuous erector spinae blocks (BESB) for
      postoperative analgesia in children and adolescents undergoing cardiac surgical procedures
      via sternotomy in the Early Recovery After Surgery (ERAS) program in a single arm, open
      label, interventional study.
    

Detailed description: 
      Regional anesthesia-and pediatric regional anesthesia in particular-is a rapidly evolving
      subfield of anesthesia practice driven with considerable urgency by the growing recognition
      that even appropriate perioperative opioid administration can have significant deleterious
      long-term effects.

      Regional anesthetics can provide targeted, continuous analgesia to select dermatomes with
      minimal additional patient risk and as such, have become routine components of opioid-sparing
      intraoperative and postoperative pain management plans for non-cardiac surgical patients at a
      single institution. In addition to the postulated benefit of reducing overall opioid exposure
      (and potentially reducing the risk for long term physiologic and behavioral dependence upon
      opioids), regional anesthetics may allow for earlier extubation after selected surgeries,
      shorter intensive care unit (ICU) stays, shorter inpatient admissions, earlier mobilization,
      fewer gastrointestinal complications, and improved patient and care team satisfaction scores.

      Historically, regional anesthetics have been avoided in cardiac surgery as most patients are
      pharmacologically anticoagulated during their procedures and are thus at increased risk for
      bleeding. This is particularly worrisome in the pediatric cardiac surgical population as many
      of these children remain intubated for an extended period of time postoperatively and
      therefore may not have reliable neurological exams in the setting of neuraxial regional
      anesthetics-potentially resulting in unrecognized hemorrhage-related acquired neurological
      deficits.

      Recently, the erector spinae block (ESB) has become popular for providing analgesia after a
      number of anterior chest and abdominal procedures. This simple interfascial plane block can
      reliably provide unilateral chest and/or abdominal wall analgesia. It has been described in
      numerous case reports and case series as an effective block for management of unilateral
      thoracotomies, unilateral rib fractures, unilateral abdominal incisions and most notably, for
      management of post-sternotomy pain when applied bilaterally. New case reports and series
      involving the ESB are being published almost weekly with a growing number of manuscripts
      specific to cardiac surgical applications. Indeed, numerous randomized controlled trials have
      investigated the analgesic efficacy of bilateral erector spinae plane blocks (BESB) compared
      with conventional treatment for pain after cardiac surgery in adult patients and have been
      published recently (2018-2019) with promising results.

      As an interfascial plane block in a compressible anatomical space, the ESB is considered safe
      in anticoagulated (or recently anticoagulated) patients. It is fast becoming a preferred
      anesthetic option at BCH for anticoagulated patients - as opposed to neuraxial (e.g.
      epidural) and paraneuraxial blocks (i.e. paravertebral) nerve blocks, which are largely
      contraindicated in this setting. Further, given its relative ease of placement, apparent
      efficacy and safety profile, it is increasingly becoming a standard option for patients
      undergoing a wide range of thoracic, abdominal and thoraco-abdominal procedures.

      The investigators recently investigated the feasibility of performing these blocks
      bilaterally in a pediatric cardiac surgical population undergoing sternotomy-based procedures
      (IRB-P00031524). At the conclusion of this 10-patient pilot, the investigators found that
      performing these blocks was technically feasible, requiring 30 minutes or less of OR time,
      resulting in no known complications. Furthermore, the data suggested an approximate 25%
      reduction in rescue opioid requirements in the first 48 hours amongst the erector spinae
      group (p=0.048).

      In order to best evaluate the efficacy of this block in the pediatric cardiac population, a
      blinded, randomized and controlled trial would be ideal. However, given that randomization
      could be challenging and the fact that blinding would not be feasible, the investigators
      believe an observational prospective cohort study is most appropriate at this time.

      As such, the investigators propose to evaluate the comparative efficacy of BESB versus
      matched historical controls who received standard of care pain management (systemic opioid
      therapy) for patients undergoing cardiac surgery via sternotomy by means of a single arm,
      open label, interventional study that will compare as the primary outcome rescue analgesic
      requirements, rendered as opiate equivalents, at 12, 24 and 48 hours, and the 24 hour period
      preceding both 72 and 96 hours postoperatively. 'Efficacy' will be considered as a threshold
      of clinical significance being defined as a 15% difference). In addition to the primary
      endpoint, we plan to evaluate the duration of intubation, length of ICU stay, median pain
      scores, incidence of PONV (postoperative nausea and vomiting; 0-6h, 6-12h and overall), time
      to mobilization and adverse events between these groups. Postoperative data collected from
      standard clinical follow-up tools, such as return to baseline sleep and activity status as
      well as pain medication requirements at home, will also be compared. In addition, the
      investigators plan to evaluate the quality of sleep and activity with a smart watch (Fitbit™
      ) during the perioperative period in the BESB group only.
    

Intervention name(s): Bilateral erector spinae blocks using ropivacaine
Intervention type(s): Drug
Intervention description(s): Bilateral chest wall nerve blocks using ropivacaine.
Other intervention name(s): Naropin
Intervention MeSH terms: Ropivacaine
Intervention model: Single Group Assignment
Intervention model description: Prospective single-arm intervention trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: regional anesthesia; cardiac surgery; erector spinae