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

NCT ID: NCT03880916

Last Updated: 2019-03-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-30
• Study Completion Date: 2020-03-31

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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)

Group Type: EXPERIMENTAL

Duloxetine

Intervention Type: DRUG

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)

Placebo

Intervention Type: DRUG

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)

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)

Group Type: PLACEBO_COMPARATOR

Duloxetine

Intervention Type: DRUG

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)

Placebo

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: 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)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Catholic University of Korea

OTHER

Sponsor Role: lead

Responsible Party

Yong In

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

KC18MESI0455

Identifier Type: -

Identifier Source: org_study_id