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Trial record 64 of 88 for:    "Neuromuscular Disease" | "Norepinephrine"

Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty?

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ClinicalTrials.gov Identifier: NCT02307305
Recruitment Status : Unknown
Verified February 2016 by JIN KYU LEE, Hanyang University Seoul Hospital.
Recruitment status was:  Recruiting
First Posted : December 4, 2014
Last Update Posted : February 19, 2016
Sponsor:
Information provided by (Responsible Party):
JIN KYU LEE, Hanyang University Seoul Hospital

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.


Condition or disease Intervention/treatment Phase
Neuropathic Pain Drug: Duloxetine Drug: celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone Phase 2

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)


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty?
Study Start Date : August 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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)

Drug: 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)
Other Name: cymbalta

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)
Other Name: celebrex, vimovo, ultracet, targin

Active Comparator: 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

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)
Other Name: celebrex, vimovo, ultracet, targin




Primary Outcome Measures :
  1. neuropathic pain(the self assessed-Leeds Assessment of Neuropathic Symptoms and Signs pain scale, S-LANSS) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Numeric rating scale for pain (NRS) [ Time Frame: 6 months ]
  2. American Knee Society knee and function score [ Time Frame: 6 months ]
  3. Western Ontario and McMaster University Arthritis Index (WOMAC) [ Time Frame: 6 months ]
  4. Geriatric depression scale-short form [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02307305


Contacts
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Contact: Jinkyu Lee +82-10-9582-7004 gaia-silver@hanmail.net
Contact: Changhoon Lee +82-10-8635-6990 toyessay@hanmail.net

Locations
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Korea, Republic of
Department of Orthopaedic Surgery, Hanyang University, College of Medicine Recruiting
Seoul, Korea, Republic of, 133-792
Contact: Jinkyu Lee    +82-10-9582-7004    gaia-silver@hanmail.net   
Sponsors and Collaborators
Hanyang University Seoul Hospital
Investigators
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Study Chair: Choonghyeok Choi Hanyang University

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Responsible Party: JIN KYU LEE, Assistant professor, Hanyang University Seoul Hospital
ClinicalTrials.gov Identifier: NCT02307305     History of Changes
Other Study ID Numbers: cymbaltaTKR
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Neuromuscular Diseases
Serotonin and Noradrenaline Reuptake Inhibitors
Neuralgia
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Peripheral Nervous System Diseases
Nervous System Diseases
Acetaminophen
Celecoxib
Naproxen
Oxycodone
Tramadol
Duloxetine Hydrochloride
Naloxone
Esomeprazole
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action