Randomized double-blind placebo trial of duloxetine in perioperative spine patients

Lee Hyer, PhD, ABPP; Ciera Scott, MS, NCC; Christine M. Mullen, MA; Laura C. McKenzie, BA; Joe Sam Robinson Jr, MD

doi:10.5055/jom.2015.0264

Authors

Lee Hyer, PhD, ABPP
Ciera Scott, MS, NCC
Christine M. Mullen, MA
Laura C. McKenzie, BA
Joe Sam Robinson Jr, MD

DOI:

https://doi.org/10.5055/jom.2015.0264

Keywords:

pain, antidepressant, spinal surgery

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.

Design: 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.

Setting: Neurosurgical outpatient and inpatient setting.

Patients: Sixty-eight patients completed the study. They received one of three types of elective spine surgery.

Interventions: Subjects were given duloxetine or placebo 2 weeks prior to surgery and continued with the regimen for more than 3 months.

Outcomes: 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.

Author Biographies

Lee Hyer, PhD, ABPP

Georgia Neurosurgical Institute, Macon, Georgia; Clinical Medical Psychology, Mercer University School of Medicine, Macon, Georgia

Ciera Scott, MS, NCC

Georgia Neurosurgical Institute, Macon, Georgia; Clinical Mental Health Counseling, Mercer University, Macon, Georgia

Christine M. Mullen, MA

Georgia Neurosurgical Institute, Macon, Georgia; Clinical Medical Psychology, Mercer University School of Medicine, Macon, Georgia

Laura C. McKenzie, BA

Georgia Neurosurgical Institute, Macon, Georgia; Clinical Medical Psychology, Mercer University School of Medicine, Macon, Georgia

Joe Sam Robinson Jr, MD

Georgia Neurosurgical Institute, Macon, Georgia

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