The Effect of Erector Spinae Plane Block Performed Under Direct Vision on Postoperative Pain in Spine Surgery
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional

Summary: 
      Spine surgery is typically associated with severe postoperative pain. Although the number of
      spine surgeries has increased day by day, postoperative pain management have been limited.
      The recently described erector spinae plane block (ESPB) is obtained by applying the local
      anesthetic drug between the fascia of the erector spinae muscles and the transverse process
      of the vertebrae. Anatomical and radiological investigations in fresh cadavers suggest that
      the potential place of influence of ESPB is dorsal and ventral spinal nerve roots. A small
      number of publications showing the analgesic efficacy of ESP in spinal surgery have been
      reported in the literature. The erector spinae muscles are easily identified during spine
      surgery, and erector spinae plane blocks can be performed under direct vision rather than via
      ultrasound guidance or simply using anatomical landmarks. Therefore, the investigators aim to
      observe the efficacy of the under direct vision erector spinae plane block on pain scores
      after spinal surgery.
    

Detailed description: 
      Approval from the university local ethics committee will be obtained. Participans will be
      informed about the potential benefits and complications after the study protocol has been
      fully and thoroughly explained. After premedication with 0.03 mg / kg iv midazolam,
      participans will be noninvasively monitored by taking into the operating room (heart rate,
      blood pressure, pulse oximetry). Anesthesia induction will delivered with fentanyl 1mcg / kg,
      propofol 2 mg / kg and rocuronium 0.6 mg / kg. The maintenance of anesthesia will be achieved
      by infusion of sevoflurane 2-3% in 50% O2/50% medical air and remifentanil infusion of
      0.1-0.5 mcg / kg / min. Thirty minutes before end of the surgery, all patients were
      intravenously administered 1 mg/kg tramadol HCl and 1gr paracetamol.

      Under direct vision ESPB technique: Erector spinae muscles and transverse processes will be
      identified by the surgeon. At the end of the surgery 20 ml bupivacaine 0.25%/lidocaine 1%
      mixture will be injected to the between of the erector spinae muscles and transverse
      processes bilaterally. In the sham comparator group, 20 ml of isotonic saline will be
      administered bilaterally by the surgeon as described above.

      After the surgery, 1 g paracetamol was intravenously administered once every 8 h. A
      patient-controlled analgesia (PCA) device, which was prepared using morphine, was attached to
      the patients and was programmed to administer concentration 0.5mg / ml ( 2cc bolus 8 min lock
      time 2cc/h infusion). This administration continued for 24 h. Postoperative pain was assessed
      using visuel analog scale (VAS) (VAS 0 = no pain, VAS 10 = most severe pain ). Duration at
      postanesthesia care unit (PACU) was recorded right from 0 h. VAS scores at 0, 1, 6, 12 and 24
      h were recorded. Postoperative nausea and vomiting (PONV) was evaluated using a numeric
      ranking scale (0 = no PONV, 1 = mild nausea, 2 = severe nausea or vomiting once attack, and 3
      = vomiting more than once attack). If PONV score was >2, the antiemetic metoclopramide Hcl
      10mg was intravenously administered.
    

Intervention name(s): Erector spinae plane block; Control group
Intervention type(s): Procedure; Procedure
Intervention description(s): Bilateral 20 ml Bupivacaine 0.25% + lidocaine 1% injected between erector spinae muscles and transverse process under direct vision.; 20 ml NaCl 0,9% used for the infiltration between the transverse process and the erector spinal muscle under direct vision on each side.
Other intervention name(s): ESP block; Sham comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: spine surgery; postoperative pain; perioperative analgesia; postoperative opioid requirement