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Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty?

Primary Purpose

Neuropathic Pain

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Duloxetine
celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone
Sponsored by
Hanyang University Seoul Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neuropathic Pain

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Department of Orthopaedic Surgery, Hanyang University, College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Duloxetin group

routine pain control group

Arm Description

Phase I (preemptive): 2 hour before surgery (30mg for 1 day) Phase II (titration): POD#1~6 (30mg for another 6 days) Phase III (maintenance): POD#7~13(60mg for 7 days) Phase IV (tapering-1): POD#14~20 (30mg for 7 days) 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)

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

Outcomes

Primary Outcome Measures

neuropathic pain(the self assessed-Leeds Assessment of Neuropathic Symptoms and Signs pain scale, S-LANSS)

Secondary Outcome Measures

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

Full Information

First Posted
November 27, 2014
Last Updated
February 17, 2016
Sponsor
Hanyang University Seoul Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02307305
Brief Title
Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty?
Official Title
Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty?
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hanyang University Seoul Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Duloxetin group
Arm Type
Experimental
Arm Description
Phase I (preemptive): 2 hour before surgery (30mg for 1 day) Phase II (titration): POD#1~6 (30mg for another 6 days) Phase III (maintenance): POD#7~13(60mg for 7 days) Phase IV (tapering-1): POD#14~20 (30mg for 7 days) 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)
Arm Title
routine pain control group
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
cymbalta
Intervention Description
Phase I (preemptive): 2 hour before surgery (30mg for 1 day) Phase II (titration): POD#1~6 (30mg for another 6 days) Phase III (maintenance): POD#7~13(60mg for 7 days) Phase IV (tapering-1): POD#14~20 (30mg for 7 days) Phase V (tapering-2): POD#21~27 (30mg another every day for 7 days)
Intervention Type
Drug
Intervention Name(s)
celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone
Other Intervention Name(s)
celebrex, vimovo, ultracet, targin
Intervention 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)
Primary Outcome Measure Information:
Title
neuropathic pain(the self assessed-Leeds Assessment of Neuropathic Symptoms and Signs pain scale, S-LANSS)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Numeric rating scale for pain (NRS)
Time Frame
6 months
Title
American Knee Society knee and function score
Time Frame
6 months
Title
Western Ontario and McMaster University Arthritis Index (WOMAC)
Time Frame
6 months
Title
Geriatric depression scale-short form
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinkyu Lee
Phone
+82-10-9582-7004
Email
gaia-silver@hanmail.net
First Name & Middle Initial & Last Name or Official Title & Degree
Changhoon Lee
Phone
+82-10-8635-6990
Email
toyessay@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Choonghyeok Choi
Organizational Affiliation
Hanyang University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Orthopaedic Surgery, Hanyang University, College of Medicine
City
Seoul
ZIP/Postal Code
133-792
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinkyu Lee
Phone
+82-10-9582-7004
Email
gaia-silver@hanmail.net

12. IPD Sharing Statement

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Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty?

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