NCT02307305

Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty?

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Hanyang University Seoul Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Both groups of participants will receive pain control regimens as follows: Preemptive analgesia : celebrex celecoxib, Patient controlled analgesia (postoperation 28 hours), During admission : celebrex BP or vimovo BP +ultracet ER BP, targin HS, Discharge medication: celebrex BP or vimovo BP, ultracet ER BP(PRN) Drug generic names: celecoxib (celebrex), naproxen/esomeprazole (vimovo), acetaminophen/tramadol (ultracet ER), oxycodone/naloxone (targin)

Conditions

• Neuropathic Pain

Interventions

Type	Name	Description
DRUG	Duloxetine	1. Phase I (preemptive): 2 hour before surgery (30mg for 1 day) 2. Phase II (titration): POD#1\~6 (30mg for another 6 days) 3. Phase III (maintenance): POD#7\~13(60mg for 7 days) 4. Phase IV (tapering-1): POD#14\~20 (30mg for 7 days) 5. Phase V (tapering-2): POD#21\~27 (30mg another every day for 7 days)
DRUG	celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone	Preemptive analgesia : celebrex, Patient controlled analgesia (postop. 28 hours), During admission : celebrex BP or vimovo BP +ultracet ER BP, targin HS, Discharge medication: celebrex BP or vimovo BP, ultracet ER BP(PRN)

Timeline

• Start date: 2014-08-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2014-12-04
• Last updated: 2016-02-19

Locations

1 site across 1 country: South Korea