Erector Spinae Block vs Morphine in Vertebral Fixation
Condition: Vertebral Subluxation; Spine Disease; Spondylolisthesis
MeSH terms: Spondylolisthesis; Spinal Diseases
Study type: Interventional

Summary: 
      The study aims to shed light about the potential role of Erector Spinae Block in the
      management of postoperative pain following vertebral fixation surgery via posterior approach.
      Patients will be randomized, the block will be performed before inducing general anesthesia,
      intraoperative management will be uniformed, while postoperative analgesia will compare cases
      (patients who received the block) versus controls (usual care with endovenous morphine
      infusion only).
    

Detailed description: 
      The study is a single-centre, interventional, prospective, case-control study. After being
      informed about the study and potential risks during preoperative anaesthetic evaluation, all
      patients giving written informed consent will be enrolled in the study.

      Inclusion criteria will be: patients undergoing vertebral fixation via posterior approach
      both for degenerative or traumatic causes, age 18-85, American Society of Anesthesiologists
      (ASA) I-III, written informed consent signed. Exclusion criteria will be: patients outside
      the 18-85 year old range, allergies or contraindications to the use of local anaesthetics and
      erector spinae block, skin infections at the puncture site, body-mass index above 40.

      The initial estimate of patients needed to detect statistically significant results has been
      estimated in 30 (15 cases versus 15 controls). Considering the surgical activity in the
      organising centre, the study should be completed before the end of 2021. Randomization will
      be made with a random sequence informatically produced. The study will be double-blinded,
      with the patient, the nurse doing the postoperative pain assessment and the statisticians not
      knowing the type of anaesthesia performed (only the anesthesist in the operating theatre is
      unblinded).

      Erector spine plane (ESP) block will be performed after general anaesthesia (GA) induction,
      with the patient already in prone position. It will be made at the vertebral level of
      surgical fixation, bilaterally, with Ropivacaine 0.4% and dexamethasone 4 mg in 20 mL of
      sodium chloride (NaCl) 0.9% per side. GA will be induced with propofol, fentanyl and
      rocuronium to all patients, while GA maintenance will be performed with total-intravenous
      anaesthesia (TIVA) with propofol and boluses of fentanyl as required. Basic blood pressure,
      pulse-oximetry, electrocardiogram, train-of-four, body temperature and bispectral index
      monitoring will be applied to every patient. At the end of the surgery all the patients will
      receive a bolus of acetaminophen 1 g and morphine 4 mg.

      Post-operative analgesia in controls will be performed by patient-controlled analgesia (PCA)
      pumps infusing boluses-at-request of morphine 1 mg (maximum once every 15 minutes) with no
      background infusion, plus acetaminophen 1 g every 8 hours for the first 48 hours.

      Post-operative analgesia in cases will be performed with PCA only releasing
      boluses-at-request (maximum 1 mg every 15 minutes) and acetaminophen 1 g every 8 hours during
      the first 48 hours.

      Postoperative pain will be assessed by a trained physician blinded to the anaesthetic
      technique employed. Numerical rating scale (NRS) and Richmond agitation-sedation scale (RASS)
      will be performed at 2-6-12-24-36-48 hours after the end of the surgery.

      The primary outcome is postoperative morphine consumption. Secondary outcomes are
      intraoperative opioid use, postoperative NRS scores, in-hospital length-of-stay and final
      patient satisfaction.

      Statistical analysis will be performed by trained professionals with STATA 14.2 for Windows.
    

Intervention name(s): Erector Spinae plane Block; Patient controlled analgesia with intravenous morphine
Intervention type(s): Procedure; Drug
Intervention description(s): Ultrasound-guided interfascial technique, aiming to block the anterior and posterior branches of the spinal nerves for multi-dermatomal analgesia. Injection of local anesthetic in the plane deep to the erector spinae muscles and superficial to the transverse processes, to achieve a craniocaudal distribution along several vertebral levels.; Patient-controlled intermittent boluses of morphine 1 mg (maximum once every 15 minutes).
Other intervention name(s): ATLANTE; ATLANTE
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cases vs control
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Anesthesia; Postoperative Pain; Postoperative Delirium; Postoperative Nausea and Vomiting; Erector Spine plane Block; Neuraxial anesthesia