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Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty?

Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty?

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02307305
Enrollment
168
Registered
2014-12-04
Start date
2014-08-31
Completion date
2016-12-31
Last updated
2016-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropathic Pain

Brief 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)

Interventions

DRUGDuloxetine

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)

DRUGcelecoxib, 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)

Sponsors

Hanyang University Seoul Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
neuropathic pain(the self assessed-Leeds Assessment of Neuropathic Symptoms and Signs pain scale, S-LANSS)6 months

Secondary

MeasureTime frame
Numeric rating scale for pain (NRS)6 months
American Knee Society knee and function score6 months
Western Ontario and McMaster University Arthritis Index (WOMAC)6 months
Geriatric depression scale-short form6 months

Countries

South Korea

Contacts

Primary ContactJinkyu Lee
gaia-silver@hanmail.net+82-10-9582-7004
Backup ContactChanghoon Lee
toyessay@hanmail.net+82-10-8635-6990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026