drugset / Trial / NCT02307305

Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty?

NCT02307305

Phase 2 Unknown 168 enrolled Hanyang University Seoul Hospital
RandomizedParallel-groupDouble-blindPrevention

Summary

Range from 24% to 44%, with a prevalence of neuropathic-type pain from 6% to 20%-cause impairment in quality of life and functional capacity after total knee arthroplasty(TKA). Duloxetine (cymbalta) is a selective serotonin and nor-epinephrine reuptake inhibitor shown to be effective in treating chronic pain. Serotonin and norepinephrine in the brain and spinal cord are believed to both mediate core mood symptoms and help regulate the perception of pain. Its effects on depression and anxiety symptoms, as well as its effect on pain perception, may be due to increasing the activity of serotonin and norepinephrine in the central nervous system. Approved for the acute and maintenance treatment of major depressive disorder, the acute treatment of generalized anxiety disorder, the management of diabetic peripheral neuropathic pain and the management of fibromyalgia, all in adults (18+). Investigators will compare the neuropathic pain following TKA in duloxetine group (n=84) with those in non-duloxetine group (n=84). Investigators will classify the participants in to 2 groups (duloxetine and non-duloxetine group) randomly, and primarily evaluate the degree of neuropathic pain using the S-LANSS pain scale (preoperatively and postoperatively 3 and 6 months). All participants will receive postoperative pain control after TKA using the same pain control regimen except duloxetine.

Timeline

Start
2014-08
Primary completion
2016-12
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Duloxetine Small molecule 60 mg
Background Acetaminophen Small molecule
Background Celecoxib Other / unclassified
Background Esomeprazole Small molecule
Background Naloxone Small molecule
Background Naproxen Small molecule
Background Oxycodone Other / unclassified
Background Tramadol Other / unclassified

Indications