Osteoarthritis, KneeNCT03880916
Effects of Duloxetine on Postoperative Wound Complication of Total Knee Arthroplasty (TKA) in Central Sensitization Patients
A study testing Duloxetine in people with Osteoarthritis, Knee, run by The Catholic University of Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Duloxetine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2019to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients for total knee arthroplasty
- having medicare insurance
- Central sensitization inventory (CSI)> 40 (Central sensitization patient )
Who cannot join
- 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)
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- Chronic opioid use (taking opioids for longer than 3 months)
- Alcohol, drug abuser
- Narcotics addiction
About this study
Official title: Effects of Duloxetine on Postoperative Wound Complication of Total Knee Arthroplasty(TKA) in Central Sensitization Patient
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
- Being tested
- Duloxetine, Placebo
- Keywords
- Duloxetine
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
- Phase I (preemptive): 2weeks before operation (30mg for 2weeks)
- Phase II (maintenance): 6weeks after operation (30mg for 6 weeks) plus routine pain control (celecoxib, pregabalin, acetaminophen/tramadol, oxycodone)
PlaceboDrug
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 group | Role | What they receive |
|---|---|---|
| Duloxetine group | Experimental | 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) Receives: Drug: Duloxetine; Drug: Placebo |
| Placebo group | Placebo comparator | 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) Receives: Drug: Duloxetine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rates of wound complication
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.
Measured: Change from baseline wound complication at postoperative 2 days, 1 week, 2 weeks, 6 weeks, 12 weeks
Hormone level
Cortisol, Serotonin, Norepinephrine related with Central Sensitization and wound healing
Measured: Change from baseline hormone level at postoperative 2, 6, 12 weeks
Secondary outcomes (2)
Pain Visual Analogue Scale (VAS) score
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.
Measured: Change from baseline VAS score at postoperative 2 days, 1, 2, 6, 12 weeks
Range of motion of the knee joint
Range of motion
Measured: Change from baseline range of motion at postoperative 2 days, 1, 2, 6, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start30 Mar 2019 (estimated)
- Primary completion31 Mar 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong In, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880916
- Sponsor's protocol ID
- KC18MESI0455
- Status last verified
- Mar 2019
- First submitted
- 6 Mar 2019
- Last updated
- 19 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Duloxetine on Postoperative Wound Complication of Total Knee Arthroplasty(TKA) in Central Sensitization Patient
- ClinicalTrials.gov ID
- NCT03880916
- Acronym / sponsor ID
- KC18MESI0455
- Conditions
- Osteoarthritis, Knee
- Keywords
- Duloxetine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 30 Mar 2019 (estimated)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duloxetine group | Experimental | Drug: Duloxetine, Drug: Placebo1. 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 group | Placebo comparator | Drug: Duloxetine, Drug: Placebo1. 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) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients for total knee arthroplasty
- having medicare insurance
- Central sensitization inventory (CSI)> 40 (Central sensitization patient )
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duloxetine1. 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 | Duloxetine group, Placebo group |
| PlaceboPhase 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) | Drug | Duloxetine group, Placebo group |
Primary outcome
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
2 secondary outcomes
Pain Visual Analogue Scale (VAS) score
Time frame: Change from baseline VAS score at postoperative 2 days, 1, 2, 6, 12 weeks
Range of motion of the knee joint
Time frame: Change from baseline range of motion at postoperative 2 days, 1, 2, 6, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Duloxetine in people with Osteoarthritis, Knee, run by The Catholic University of Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rates of wound complication (time frame: Change from baseline wound complication at postoperative 2 days, 1 week, 2 weeks, 6 weeks, 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.