Randomized double-blind placebo trial of duloxetine in perioperative spine patients
| Autor: | Laura C. Mckenzie, Christine M. Mullen, Ciera Scott, Lee Hyer, Joe Sam Robinson |
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| Rok vydání: | 2015 |
| Předmět: |
Male
medicine.medical_specialty Thiophenes Duloxetine Hydrochloride Placebo Perioperative Care law.invention chemistry.chemical_compound Randomized controlled trial Double-Blind Method law Medicine Duloxetine Humans Pharmacology (medical) Orthopedic Procedures Brief Pain Inventory Pain Postoperative Dose-Response Relationship Drug business.industry General Medicine Perioperative Middle Aged Analgesics Opioid Regimen Anesthesiology and Pain Medicine Treatment Outcome chemistry Opioid Anesthesia Physical therapy Drug Therapy Combination Female Spinal Diseases business Selective Serotonin Reuptake Inhibitors medicine.drug Follow-Up Studies |
| Zdroj: | Journal of opioid management. 11(2) |
| ISSN: | 1551-7489 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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