Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty?
Information source: Hanyang University Seoul Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neuropathic Pain
Intervention: Duloxetine (Drug); celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Hanyang University Seoul Hospital Official(s) and/or principal investigator(s): Choonghyeok Choi, Study Chair, Affiliation: Hanyang University
Overall contact: Jinkyu Lee, Phone: +82-10-9582-7004, Email: gaia-silver@hanmail.net
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.
Clinical Details
Official title: Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty?
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: neuropathic pain(the self assessed-Leeds Assessment of Neuropathic Symptoms and Signs pain scale, S-LANSS)
Secondary outcome: Numeric rating scale for pain (NRS)American Knee Society knee and function score Western Ontario and McMaster University Arthritis Index (WOMAC) Geriatric depression scale-short form
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)
Eligibility
Minimum age: 50 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Jinkyu Lee, Phone: +82-10-9582-7004, Email: gaia-silver@hanmail.net
Department of Orthopaedic Surgery, Hanyang University, College of Medicine, Seoul 133-792, Korea, Republic of; Recruiting Jinkyu Lee, Phone: +82-10-9582-7004, Email: gaia-silver@hanmail.net
Additional Information
Starting date: August 2014
Last updated: December 1, 2014
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