Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty?
1 other identifier
interventional
168
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 27, 2014
CompletedFirst Posted
Study publicly available on registry
December 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFebruary 19, 2016
February 1, 2016
2.3 years
November 27, 2014
February 17, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
neuropathic pain(the self assessed-Leeds Assessment of Neuropathic Symptoms and Signs pain scale, S-LANSS)
6 months
Secondary Outcomes (4)
Numeric rating scale for pain (NRS)
6 months
American Knee Society knee and function score
6 months
Western Ontario and McMaster University Arthritis Index (WOMAC)
6 months
Geriatric depression scale-short form
6 months
Study Arms (2)
Duloxetin group
EXPERIMENTAL1. 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)
routine pain control group
ACTIVE COMPARATORPreemptive 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
Interventions
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)
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)
Eligibility Criteria
You may qualify if:
- Osteoarthritis of knee requiring TKA
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Orthopaedic Surgery, Hanyang University, College of Medicine
Seoul, 133-792, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Choonghyeok Choi
Hanyang University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
November 27, 2014
First Posted
December 4, 2014
Study Start
August 1, 2014
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
February 19, 2016
Record last verified: 2016-02