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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

Page last updated: August 23, 2015

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