Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty?

NCT ID: NCT02307305

Last Updated: 2016-02-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-12-31

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)

Conditions

Neuropathic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Duloxetin group

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)

Group Type: EXPERIMENTAL

Duloxetine

Intervention Type: DRUG

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)

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

Intervention Type: DRUG

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)

routine pain control group

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: 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)

Intervention Type: DRUG

Other Intervention Names

cymbalta; celebrex, vimovo, ultracet, targin

Eligibility 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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanyang University Seoul Hospital

OTHER

Sponsor Role: lead

Responsible Party

JIN KYU LEE

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Choonghyeok Choi

Role: STUDY_CHAIR

Hanyang University

Locations

Department of Orthopaedic Surgery, Hanyang University, College of Medicine

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Jinkyu Lee

Role: CONTACT

gaia-silver@hanmail.net

+82-10-9582-7004

Changhoon Lee

Role: CONTACT

toyessay@hanmail.net

+82-10-8635-6990

Facility Contacts

Jinkyu Lee

Role: primary

gaia-silver@hanmail.net

+82-10-9582-7004

Other Identifiers

cymbaltaTKR

Identifier Type: -

Identifier Source: org_study_id