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Effects of Duloxetine on Postoperative Wound Complication of Total Knee Arthroplasty (TKA) in Central Sensitization Patients

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ClinicalTrials.gov Identifier: NCT03880916
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Yong In, The Catholic University of Korea

Tracking Information
First Submitted Date  ICMJE March 6, 2019
First Posted Date  ICMJE March 19, 2019
Last Update Posted Date March 19, 2019
Estimated Study Start Date  ICMJE March 30, 2019
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
  • The rates of wound complication [ Time Frame: Change from baseline wound complication at postoperative 2 days, 1 week, 2 weeks, 6 weeks, 12 weeks ]
    wound dehiscence, suture granuloma, prolonged wound ooze occurring after postoperative day 5, significant hematoma formation, or surgical site infection recorded. Post-operative additional interventions included delayed discharge from hospital due to wound problem, additional outpatient clinic visits to examine the surgical wound, local application of antibiotic ointment, superficial wound debridement or suturing in the office, hematoma aspiration, prescription of antibiotics, or reoperation.
  • Hormone level [ Time Frame: Change from baseline hormone level at postoperative 2, 6, 12 weeks ]
    Cortisol, Serotonin, Norepinephrine related with Central Sensitization and wound healing
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
  • Pain Visual Analogue Scale (VAS) score [ Time Frame: Change from baseline VAS score at postoperative 2 days, 1, 2, 6, 12 weeks ]
    Pain evaluation, It will be measured on a scale of 10 points. Minimum point is 0 and maximum point is 10. Higher values represent a worse outcome.
  • Range of motion of the knee joint [ Time Frame: Change from baseline range of motion at postoperative 2 days, 1, 2, 6, 12 weeks ]
    Range of motion
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Duloxetine on Postoperative Wound Complication of Total Knee Arthroplasty (TKA) in Central Sensitization Patients
Official Title  ICMJE Effects of Duloxetine on Postoperative Wound Complication of Total Knee Arthroplasty(TKA) in Central Sensitization Patient
Brief Summary Postoperative wound complications such as wound dehiscence, skin necrosis, persistent wound drainage, delayed healing, and superficial skin infection could have devastating consequences, leading to arthroplasty failure and patient morbidity requiring additional operations and prolonging hospitalization with substantial burden in cost of care. Recently, interest and research on central sensitization (CS) have been increasing. CS is closely correlated with excessive pain. It has two main characteristics: allodynia and hyperalgesia. CS is an abnormal and intense enhancement of pain mechanism by the central nervous system. One of the mechanisms by which this excessive pain occurs in CS is reduced activation of descending inhibitory pathway associated with deficiency in pathways primarily in response to serotonin and norepinephrine. Serotonin plays an important role in normal wound healing by affecting the formation of neovascularization, inflammatory reactions, fibroblasts and tissue proliferation essential for wound healing. Norepinephrine is also closely related to wound healing by controlling chemotaxis of macrophage essential for normal wound healing. CS is a risk factor for the development of postoperative wound complication after primary Total Knee Arthroplasty (TKA). Preclinical models of central sensitization suggest that duloxetine is effective in the treatment. Investigators will compare the wound complication following TKA of central sensitization patients in duloxetine group (n=40) with those in non-duloxetine group (n=40). Investigators will classify the central sensitization patients by central sensitization inventory and divide the central sensitization patients in to 2 groups (duloxetine and non-duloxetine group) randomly. Investigators checks the wound complication after primary TKA and visual assessment scale at preoperative, postoperative 2 days and 1, 2,6,12 weeks. All participants will receive postoperative pain control after TKA using the same pain control regimen and wound dressing regimen except duloxetine.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE
  • Drug: Duloxetine
    1. Phase I (preemptive): 2weeks before operation (30mg for 2weeks)
    2. Phase II (maintenance): 6weeks after operation (30mg for 6 weeks) plus routine pain control (celecoxib, pregabalin, acetaminophen/tramadol, oxycodone)
  • Drug: Placebo
    Phase I (preemptive): 2weeks before operation (Placebo for 2weeks) Phase II (maintenance): 6weeks after operation (Placebo for 6 weeks) plus routine pain control (celecoxib, pregabalin, acetaminophen/tramadol, oxycodone)
Study Arms  ICMJE
  • Experimental: Duloxetine group
    1. Phase I (preemptive): 2weeks before operation (30mg for 2weeks)
    2. Phase II (maintenance): 6weeks after operation (30mg for 6 weeks) plus routine pain control (celecoxib, pregabalin, acetaminophen/tramadol, oxycodone)
    Interventions:
    • Drug: Duloxetine
    • Drug: Placebo
  • Placebo Comparator: Placebo group
    1. Phase I (preemptive): 2weeks before operation (Placebo for 2weeks)
    2. Phase II (maintenance): 6weeks after operation (Placebo for 6 weeks) plus routine pain control (celecoxib, pregabalin, acetaminophen/tramadol, oxycodone)
    Interventions:
    • Drug: Duloxetine
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 18, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2020
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients for total knee arthroplasty
  • having medicare insurance
  • Central sensitization inventory (CSI)> 40 (Central sensitization patient )

Exclusion Criteria:

  • Rheumatoid arthritis
  • Other inflammatory arthritis
  • Neuropsychiatric patients
  • Allergy or intolerance to study medications
  • Patients with an American society of anesthesiologist (ASA) classification 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)
  • Alcohol, drug abuser
  • Narcotics addiction
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03880916
Other Study ID Numbers  ICMJE KC18MESI0455
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yong In, The Catholic University of Korea
Study Sponsor  ICMJE The Catholic University of Korea
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The Catholic University of Korea
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP