Analgesic Effect of Bilateral Erector Spinae Plane Block With Ropivacaine After Sternotomy for Cardiac Surgery
Condition: Cadiac Surgery; Median Sternotomy; Regional Anesthesia; Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The sternotomy site is the most painful area after cardiac surgery. Erector spinae plane
      block is effective in thoracic and abdominal surgery, but literature is lacking in cardiac
      surgery. The bilateral erector spinae plane block could reduce pain at rest and during
      mobilization, reduce opioids consumption, decrease postoperative complications, improve
      respiratory outcomes and improve patient comfort and satisfaction. The research hypothesis is
      that a single shot bilateral erector spinae plane block could reduce pain during mobilization
      during the first 48 hours after cardiac surgery performed with sternotomy
    

Detailed description: 
      Background:

      Pain after cardiac surgery is mostly localized at the sternotomy site. To improve
      postoperative pain management a number of technics involving loco-regional anesthesia have
      been developed. The epidural analgesia is the gold standard but the risk of epidural hematoma
      with heparinization in this surgery avoids its utilization in clinical practice. The
      paravertebral block can be used equally but there is a risk of pneumothorax. The erector
      spinae plane block could be a solution as it is a more superficial block. It's efficacity was
      proven in thoracic and abdominal surgery, but literature is lacking in cardiac surgery. A
      bilateral erector spinae plane block after cardiac surgery could significantly reduce pain at
      rest and during mobilization, reduce opioids consumption, decrease postoperative
      complications, improve respiratory outcomes and improve patient comfort and satisfaction.

      The main objective of this to study is to examine the efficacity of a single-shot bilateral
      erector spinae plane block on pain reduction during mobilization during the first 48 hours
      after cardiac surgery compared to a control group.

      The primary outcome:

      Pain scale at patient mobilization during the first postoperative 48 hours measured by
      numerical pain scale.

      Study design:

      Prospective, randomized, doubled-blinded, single-center controlled trial with two groups:

        1. The ropivacaine group (42 patients): a bilateral erector spinae block will be performed
           after patient arrival in the intensive care unit before wake up from anesthesia with
           20ml of Ropivacaine 2mg/ml bilaterally.

        2. The control group (42 patients): a sham block will be performed bilaterally in the same
           conditions.
    

Intervention name(s): Ropivacaine 0,2% Injectable Solution; Control group
Intervention type(s): Drug; Other
Intervention description(s): Echo-guided bilateral erector spinae block; Sham block
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The ropivacaine group (42 patients): Echo-guided bilateral erector spinae block at the arrival in the intensive care unit. 20ml of Ropivacaine 2mg/ml for each side.
The control group (42 patients): Sham block bilaterally.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative analgesia; Erector spinae plane block; Local anesthetics; Ropivacaine; Sternotomy