Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty?

Neuropathic Pain Clinical Trial

Official title:

Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02307305
• Other study ID #: cymbaltaTKR
• Status: Recruiting
• Phase: Phase 2
• First received: November 27, 2014
• Last updated: February 17, 2016
• Start date: August 2014
• Est. completion date: December 2016

Study information

• Verified date: February 2016
• Source: Hanyang University Seoul Hospital
• Contact: Jinkyu Lee
• Phone: +82-10-9582-7004
• Email: gaia-silver[@]hanmail.net
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• Osteoarthritis of knee requiring TKA

Exclusion Criteria:

• Rheumatoid arthritis

• Other inflammatory arthritis

• Neuropsychiatric patients

• Hepatic insufficiency

• Renal insufficiency

• Patients older than 75

• Allergy or intolerance to study medications

• Patients with an ASA of IV (angina, congestive heart failure, dementia, cerebrovascular accident)

• Chronic gabapentin or pregabalin use (regular use for longer than 3 months)

• Chronic opioid use (taking opioids for longer than 3 months)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Pain
• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• Duloxetine
Phase I (preemptive): 2 hour before surgery (30mg for 1 day) Phase II (titration): POD#1~6 (30mg for another 6 days) Phase III (maintenance): POD#7~13(60mg for 7 days) Phase IV (tapering-1): POD#14~20 (30mg for 7 days) Phase V (tapering-2): POD#21~27 (30mg another every day for 7 days)
• 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)

Locations

Country	Name	City	State
Korea, Republic of	Department of Orthopaedic Surgery, Hanyang University, College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanyang University Seoul Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neuropathic pain(the self assessed-Leeds Assessment of Neuropathic Symptoms and Signs pain scale, S-LANSS)		6 months	No
Secondary	Numeric rating scale for pain (NRS)		6 months	No
Secondary	American Knee Society knee and function score		6 months	No
Secondary	Western Ontario and McMaster University Arthritis Index (WOMAC)		6 months	No
Secondary	Geriatric depression scale-short form		6 months	No