title: Pain and functional improvement effects of methylene blue injection on the soft tissue around fusion site after traumatic thoracolumbar fixation: A double-blind, randomized placebo-controlled study.
abstract: OBJECTIVE
  Fractures of the thoracolumbar spine can cause pain, long-term reductions in quality of life (QOL), and neural deficits. The aim of this study was to investigate the effects of methylene blue (MB) on preventing postoperative pain and improving QOL in patients with throracolumbar fractures undergoing posterior pedicle screw fixation.
  
  
  METHODS
  Fifty patients underwent standard posterior pedicular screw fixation for stabilization of the thoracolumbar fractures: 25 received 1ml of MB solution at a concentration of 0.5% and 25 received normal saline on the soft tissue around fusion site. Primary outcomes were the control of pain, evaluated at 48h, 2 and 6 months after surgery with the use of a visual analog scale (VAS), and the improvement of QOL, assessed 2 and 6 months postoperatively by means of Oswestry Disability Index (ODI) questionnaire.
  
  
  RESULTS
  The mean VAS scores for pain were significantly lower in the MB group compared with the control group at 2 months (1.30±0.45 vs. 2.60±1.19, P<0.001) and 6 months (1.17±0.37 vs. 1.60±0.87; P=0.028) after treatment. At 2 months after the surgery, the mean ODI score was significantly lower in the MB-treated patients than the control group (20.4±10.92 vs. 34.8±15.11; P=0.001). The ODI score in the MB-treated patients was better than the control group at 6 months after the surgery (12.2±11.66 vs. 20.8±11.14; P=0.016).
  
  
  CONCLUSIONS
  A single dose of MB on the soft tissue around fusion site shows promising results in terms of safety, reduction of postoperative pain, and functional results when compared with placebo 6 months after surgery.
authors: Shiraz Neuroscience Research Center, Shiraz University of Medical Sciences, Shiraz, Iran; Neurosurgery Department, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: farrokhimr2@gmail.com.
authors: Majid Reza
authors: MR
authors: Farrokhi
authors: Shiraz Neuroscience Research Center, Shiraz University of Medical Sciences, Shiraz, Iran; Neurosurgery Department, Shiraz University of Medical Sciences, Shiraz, Iran.
authors: Hamed
authors: H
authors: Yazdanpanah
authors: Shiraz Neuroscience Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.
authors: Mehrnaz
authors: M
authors: Gholami
authors: Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.
authors: Farnaz
authors: F
authors: Farrokhi
authors: Orthopedic Department, Shiraz University of Medical Sciences, Shiraz, Iran.
authors: Amir Reza
authors: AR
authors: Mesbahi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001863:Bone Screws; D004311:Double-Blind Method; D004791:Enzyme Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D005260:Female; D005593:Fracture Fixation, Internal / Q000379:methods*; D006801:Humans; D008159:Lumbar Vertebrae / Q000601:surgery*; D008297:Male; D008751:Methylene Blue / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010149:Postoperative Pain / Q000188:drug therapy*; D011788:Quality of Life; D016103:Spinal Fractures / Q000601:surgery*; D013904:Thoracic Vertebrae / Q000601:surgery*; D055815:Young Adult
chemical_list: D004791:Enzyme Inhibitors; D008751:Methylene Blue
keywords: Clinical outcomes; Methylene blue; Posterior pedicular screw fixation; Postoperative pain; Quality of life; Traumatic thoracolumbar fixation