title: Randomized double-blind placebo trial of duloxetine in perioperative spine patients.
abstract: OBJECTIVE
  This study describes a single-site investigation on the effects of a randomized double-blind placebo trial targeting duloxetine added to opioid use (duloxetine + opioid) against a comparator (placebo + opioid) in spine surgery patients, independent of major depression.
  
  
  METHODS
  The double-blind comparator study assessed two groups on opioids: one using duloxetine and the other a placebo. Subjects were administered the respective medication 2 weeks prior to surgery and continued on this for more than 3 months. Subjects were assessed at three times: prior to surgery, 4 weeks postsurgery, and 12 weeks postsurgery. They completed a battery of tests assessing for pain, adjustment, and psychiatric problems.
  
  
  METHODS
  Neurosurgical outpatient and inpatient setting.
  
  
  METHODS
  Sixty-eight patients completed the study. They received one of three types of elective spine surgery.
  
  
  METHODS
  Subjects were given duloxetine or placebo 2 weeks prior to surgery and continued with the regimen for more than 3 months.
  
  
  RESULTS
  The primary focus was pain and second on adjustment factors and psychiatric symptoms: depression and anxiety. The amount of opioid use presurgery and postsurgery was also evaluated.
  
  
  RESULTS
  There were differences among the groups on Brief Pain Inventory (BPI)-Average, the core pain marker, and BPI-Sleep. Within-subject analyses showed that duloxetine subjects improved significantly from baseline. For function, post-CIBIC and post-Functional Adjustment Questionnaire were significant, favoring duloxetine. Reduction of opioid use was not a factor; both groups' utilization declined. For affect, both groups were significantly improved over time.
  
  
  CONCLUSIONS
  Duloxetine seems to improve pain, assist with maintaining function, and reduce intensity of affect.
authors.affiliation: Georgia Neurosurgical Institute, Macon, Georgia; Clinical Medical Psychology, Mercer University School of Medicine, Macon, Georgia.
authors.forename: Lee
authors.initials: L
authors.lastname: Hyer
authors.affiliation: Georgia Neurosurgical Institute, Macon, Georgia; Clinical Mental Health Counseling, Mercer University, Macon, Georgia.
authors.forename: Ciera
authors.initials: C
authors.lastname: Scott
authors.affiliation: Georgia Neurosurgical Institute, Macon, Georgia; Clinical Medical Psychology, Mercer University School of Medicine, Macon, Georgia.
authors.forename: Christine M
authors.initials: CM
authors.lastname: Mullen
authors.affiliation: Georgia Neurosurgical Institute, Macon, Georgia; Clinical Medical Psychology, Mercer University School of Medicine, Macon, Georgia.
authors.forename: Laura C
authors.initials: LC
authors.lastname: McKenzie
authors.affiliation: Georgia Neurosurgical Institute, Macon, Georgia.
authors.forename: Joe Sam
authors.initials: JS
authors.lastname: Robinson
mesh_terms: D000701:Analgesics, Opioid / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D000068736:Duloxetine Hydrochloride; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D019637:Orthopedic Procedures / Q000379:methods*; D010149:Postoperative Pain / Q000517:prevention & control*; D019990:Perioperative Care / Q000379:methods*; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage; D013122:Spinal Diseases / Q000601:surgery*; D013876:Thiophenes / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D000068736:Duloxetine Hydrochloride; D017367:Selective Serotonin Reuptake Inhibitors; D013876:Thiophenes