Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty?

Hanyang University Seoul Hospital

Status and phase: Unknown; Phase 2

Conditions: Neuropathic Pain

Treatments: Drug: celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone; Drug: Duloxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT02307305

cymbaltaTKR

Details and patient eligibility

About

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.

Full 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)

Enrollment: 168 estimated patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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168 participants in 2 patient groups

Duloxetin group

Experimental group

Description:

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) plus routine pain control (celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone)

Treatment:

Drug: Duloxetine

Drug: celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone

routine pain control group

Active Comparator group

Description:

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) Other name of drugs: celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone

Treatment:

Drug: celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone