Total Knee ArthroplastyNCT04719585
Comparison of Opioid and Duloxetine for Postoperative Pain Control After Total Knee Arthroplasty: RCT
A study testing Duloxetine vs. Opioid in people with Total Knee Arthroplasty and Osteoarthritis, Knee, run by The Catholic University of Korea.
Trial summary
Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) has recently been reported to be effective in controlling pain in persistent chronic pain caused by joint surgery and arthritis. However, opioids are important drugs that still play a pivotal role in pain control after surgery. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Total Knee Arthroplasty, Osteoarthritis, Knee
- What is being tested?
- Duloxetine vs. Opioid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Dec 2022
- 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
- Adults over age 19
- Patients undergoing total knee arthroplasty for osteoarthritis of the knee joint
- Patients with a pain VAS scale of 4 or more out of 10 after TKA with a pain in the knee joint during daily activities on flat ground
- Patients who are willing or able to follow doctor's instructions, including joint exercises
- Patients not participating in other clinical trials
- Patients who have received sufficient explanation for this clinical trial and agreed to participate
Who cannot join
- Patients with secondary knee osteoarthritis
- Patients with hypersensitivity reactions and serious side effects to duloxetine or opioid
- Patients with inflammatory arthritis or crystalline arthritis
- Local infection to the lower extremities of the pain area, sepsis, or previous neurological abnormalities.
- Patients who underwent meniscus surgery on the knee joint in the painful area
- If there is construction or deformation of the knee joint in the pain area
Show all 9Show fewer
- Patients with serious heart-related diseases such as cardiac arrest, a history of cerebral infarction, or ischemic heart disease
- Patients with high blood pressure with poor blood pressure control (Systolic Blood Pressure of> 150 mmHg or Diastolic Blood Pressure> 95 mmHg)
- Patients with abnormal liver function (ALT)> 2.0 times the upper limit of normal (ULN) or blood urea nitrogen (BUN) or serum creatinine> 2.0 times ULN)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Opioid and Duloxetine for Postoperative Pain Control After Total Knee Arthroplasty: Randomized Controlled Trial
Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) has recently been reported to be effective in controlling pain in persistent chronic pain caused by joint surgery and arthritis. However, opioids are important drugs that still play a pivotal role in pain control after surgery. In this study, we want to investigate the difference of the result among patients who undego total knee arthroplasty (TKA), of the result of pain control after TKA from SNRI administration of duloxetine and opioid in two groups. We designed a randomized controlled study (RCT) for the effect of post-TKA pain control to determine whether SNRI is effective in controlling post-TKA pain compared to Opioid, and whether there is a difference in side effects.
Read the detailed description
For patients undergoing TKA for osteoarthritis of the knee joint, pain control will be performed using the same pain control technique (pain control using NSAID) until discharge (1 week after surgery) after surgery. By evaluating the Visual Analogue Scale (VAS), which is known as the patient's pain criterion, the study will be conducted only on patients whose score is more severe than 4 points. Among these subjects, only patients who agreed to the study will be assigned to the group taking duloxetine and the group taking opioids with the same probability according to the randomization table for one week after surgery, that is, upon discharge. In our hospital, almost all patients with total knee arthroplasty are discharged one week after surgery, except for special cases such as morbidity of systemic diseases such as cardiopulmonary dysfunction or acute infection after surgery.
Among the co-researchers, one researcher who is in charge of only patient assignment is selected, and the person in charge creates a randomization table through computer generated randomization. During the assignment process, the assignee will not know in advance the next assignment group, and the randomization table is kept in secret. The assignee does not intervene in any other process of this study, and participates only in the task of selecting the assigned group using random checks. The evaluation is evaluated by an evaluator who is not aware of the patient allocation according to the randomization table among researchers participating in the clinical study. Such a study plan will be fully explained to the patient in the process of seeking consent for the study before discharge, as it is recorded in detail in the subject description, and only patients who have obtained this consent will be the subject of the study.
This criterion is established because both duloxetine and opioid are not used for all patients after surgery, but for additional pain control after surgery. Prior to discharge, the drug is prescribed for a total of 6 weeks by dividing the duloxetine-administered group and the opioid-administering group, respectively. In general, if duloxetine is not taken for more than 10 weeks, the frequency of discontinuation syndrome that can occur after discontinuation is remarkably low, so the administration period of 6 weeks was set as the administration period. The follow-up periods for out-patient clinic are 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after the TKA surgery. During the follow-up period, NSAIDs will be prescribed the same in both groups.
As an additional rescue medication, 650 mg of acetaminophen will be allowed to use up to 2g per day.
Before surgery, 1 week after surgery, 2 weeks, 6 weeks, 3 months, 6 months, 1 year The degree of pain will be measured using the VAS pain scale, WOMAC pain scale, Brief pain inventory (BPI), Intermittent and Constant Osteoarthritis The pain (ICOAP) score is used to measure additional pain scales in various ways. In addition, SF-36 will be measured before surgery, at 6 weeks, 3 months, 6 months, and 1 year after surgery.
- Conditions
- Total Knee Arthroplasty, Osteoarthritis, Knee
- Being tested
- Duloxetine vs. Opioid
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duloxetine vs. OpioidDrug
Prior to discharge, the drug is prescribed for a total of 6 weeks by dividing the duloxetine-administered group and the opioid-administering group, respectively. The administration period of duloxetine or opioid is 6 weeks. The follow-up periods for out-patient clinic are 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after the TKA surgery. During the follow-up period, NSAIDs will be prescribed the same in both groups. As an additional rescue medication, 650 mg of acetaminophen will be allowed to use up to 2g per day.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Duloxetine group | Experimental | Prior to discharge, the drug is prescribed for a total of 6 weeks by dividing the duloxetine-administered group and the opioid-administering group, respectively. The administration period of duloxetine is 6 weeks. The follow-up periods for out-patient clinic are 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after the TKA surgery. During the follow-up period, NSAIDs will be prescribed the same in both groups. As an additional rescue medication, 650 mg of acetaminophen will be allowed to use up to 2g per day. Receives: Drug: Duloxetine vs. Opioid |
| Active comparator: Opioid group | Active comparator | Prior to discharge, the drug is prescribed for a total of 6 weeks by dividing the duloxetine-administered group and the opioid-administering group, respectively. The administration period of opioid is 6 weeks. The follow-up periods for out-patient clinic are 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after the TKA surgery. During the follow-up period, NSAIDs will be prescribed the same in both groups. As an additional rescue medication, 650 mg of acetaminophen will be allowed to use up to 2g per day. Receives: Drug: Duloxetine vs. Opioid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Visual Analogue Scale
score ranges 0 to 10, higher score means more painful
Measured: changes of the VAS score from the day before TKA operation and at postoperative 1, 2, 6, 12, 24th weeks and 1 year
Brief pain inventory (BPI)
includes 7 categories. each category score ranges 0 to 10, higher score means more painful
Measured: changes of the BPI score from the day before TKA operation and at postoperative 1, 2, 6, 12, 24th weeks and 1 year
Secondary outcomes (4)
WOMAC(Western Ontario and McMaster University Arthritis Index ) pain scale
The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). higher score means more painful.
Measured: changes of the WOMAC score from the day before TKA operation and at postoperative 1, 2, 6, 12, 24tn weeks and 1 year
Intermittent and Constant Osteoarthritis pain (ICOAP) score
11-item tool that assess pain at knee joint. The 11 items are scored froma 0 to 4 with 0 being no pain and 4 being extreme pain
Measured: changes of the ICOAP score from the day before TKA operation and at postoperative 1, 2, 6, 12, 24tn weeks and 1 year
SF-36(Short Form Health Survey - 36) score
a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability
Measured: changes of the SF-36 score from the day before TKA operation and at postoperative 1, 2, 6, 12, 24tn weeks and 1 year
Range of Motion
Measured: The day before TKA operation, postoperative 1, 2, 6, 12, 24 weeks and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study startJan 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 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
- NCT04719585
- Sponsor's protocol ID
- KC20MISI0531
- Status last verified
- Jan 2021
- First submitted
- 6 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- 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 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Opioid and Duloxetine for Postoperative Pain Control After Total Knee Arthroplasty: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04719585
- Acronym / sponsor ID
- KC20MISI0531
- Conditions
- Total Knee Arthroplasty, Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 22 Jan 2021 (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.
Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) has recently been reported to be effective in controlling pain in persistent chronic pain caused by joint surgery and arthritis. However, opioids are important drugs that still play a pivotal role in pain control after surgery. In this study, we want to investigate the difference of the result among patients who undego total knee arthroplasty (TKA), of the result of pain control after TKA from SNRI administration of duloxetine and opioid in two groups. We designed a randomized controlled study (RCT) for the effect of post-TKA pain control to determine whether SNRI is effective in controlling post-TKA pain compared to Opioid, and whether there is a difference in side effects.
Detailed description
For patients undergoing TKA for osteoarthritis of the knee joint, pain control will be performed using the same pain control technique (pain control using NSAID) until discharge (1 week after surgery) after surgery. By evaluating the Visual Analogue Scale (VAS), which is known as the patient's pain criterion, the study will be conducted only on patients whose score is more severe than 4 points. Among these subjects, only patients who agreed to the study will be assigned to the group taking duloxetine and the group taking opioids with the same probability according to the randomization table for one week after surgery, that is, upon discharge. In our hospital, almost all patients with total knee arthroplasty are discharged one week after surgery, except for special cases such as morbidity of systemic diseases such as cardiopulmonary dysfunction or acute infection after surgery.
Among the co-researchers, one researcher who is in charge of only patient assignment is selected, and the person in charge creates a randomization table through computer generated randomization. During the assignment process, the assignee will not know in advance the next assignment group, and the randomization table is kept in secret. The assignee does not intervene in any other process of this study, and participates only in the task of selecting the assigned group using random checks. The evaluation is evaluated by an evaluator who is not aware of the patient allocation according to the randomization table among researchers participating in the clinical study. Such a study plan will be fully explained to the patient in the process of seeking consent for the study before discharge, as it is recorded in detail in the subject description, and only patients who have obtained this consent will be the subject of the study.
This criterion is established because both duloxetine and opioid are not used for all patients after surgery, but for additional pain control after surgery. Prior to discharge, the drug is prescribed for a total of 6 weeks by dividing the duloxetine-administered group and the opioid-administering group, respectively. In general, if duloxetine is not taken for more than 10 weeks, the frequency of discontinuation syndrome that can occur after discontinuation is remarkably low, so the administration period of 6 weeks was set as the administration period. The follow-up periods for out-patient clinic are 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after the TKA surgery. During the follow-up period, NSAIDs will be prescribed the same in both groups.
As an additional rescue medication, 650 mg of acetaminophen will be allowed to use up to 2g per day.
Before surgery, 1 week after surgery, 2 weeks, 6 weeks, 3 months, 6 months, 1 year The degree of pain will be measured using the VAS pain scale, WOMAC pain scale, Brief pain inventory (BPI), Intermittent and Constant Osteoarthritis The pain (ICOAP) score is used to measure additional pain scales in various ways. In addition, SF-36 will be measured before surgery, at 6 weeks, 3 months, 6 months, and 1 year after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Duloxetine group | Experimental | Drug: Duloxetine vs. OpioidPrior to discharge, the drug is prescribed for a total of 6 weeks by dividing the duloxetine-administered group and the opioid-administering group, respectively. The administration period of duloxetine is 6 weeks. The follow-up periods for out-patient clinic are 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after the TKA surgery. During the follow-up period, NSAIDs will be prescribed the same in both groups. As an additional rescue medication, 650 mg of acetaminophen will be allowed to use up to 2g per day. |
| Active comparator: Opioid group | Active comparator | Drug: Duloxetine vs. OpioidPrior to discharge, the drug is prescribed for a total of 6 weeks by dividing the duloxetine-administered group and the opioid-administering group, respectively. The administration period of opioid is 6 weeks. The follow-up periods for out-patient clinic are 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after the TKA surgery. During the follow-up period, NSAIDs will be prescribed the same in both groups. As an additional rescue medication, 650 mg of acetaminophen will be allowed to use up to 2g per day. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults over age 19
- Patients undergoing total knee arthroplasty for osteoarthritis of the knee joint
- Patients with a pain VAS scale of 4 or more out of 10 after TKA with a pain in the knee joint during daily activities on flat ground
- Patients who are willing or able to follow doctor's instructions, including joint exercises
- Patients not participating in other clinical trials
Key exclusion criteria (9 listed)
- Patients with secondary knee osteoarthritis
- Patients with hypersensitivity reactions and serious side effects to duloxetine or opioid
- Patients with inflammatory arthritis or crystalline arthritis
- Local infection to the lower extremities of the pain area, sepsis, or previous neurological abnormalities.
- Patients who underwent meniscus surgery on the knee joint in the painful area
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 |
|---|---|---|
| Duloxetine vs. OpioidPrior to discharge, the drug is prescribed for a total of 6 weeks by dividing the duloxetine-administered group and the opioid-administering group, respectively. The administration period of duloxetine or opioid is 6 weeks. The follow-up periods for out-patient clinic are 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after the TKA surgery. During the follow-up period, NSAIDs will be prescribed the same in both groups. As an additional rescue medication, 650 mg of acetaminophen will be allowed to use up to 2g per day. | Drug | Active comparator: Opioid group, Experimental: Duloxetine group |
Primary outcome
Pain Visual Analogue Scale
Time frame: changes of the VAS score from the day before TKA operation and at postoperative 1, 2, 6, 12, 24th weeks and 1 year
score ranges 0 to 10, higher score means more painful
Brief pain inventory (BPI)
Time frame: changes of the BPI score from the day before TKA operation and at postoperative 1, 2, 6, 12, 24th weeks and 1 year
includes 7 categories. each category score ranges 0 to 10, higher score means more painful
4 secondary outcomes
WOMAC(Western Ontario and McMaster University Arthritis Index ) pain scale
Time frame: changes of the WOMAC score from the day before TKA operation and at postoperative 1, 2, 6, 12, 24tn weeks and 1 year
Intermittent and Constant Osteoarthritis pain (ICOAP) score
Time frame: changes of the ICOAP score from the day before TKA operation and at postoperative 1, 2, 6, 12, 24tn weeks and 1 year
SF-36(Short Form Health Survey - 36) score
Time frame: changes of the SF-36 score from the day before TKA operation and at postoperative 1, 2, 6, 12, 24tn weeks and 1 year
Range of Motion
Time frame: The day before TKA operation, postoperative 1, 2, 6, 12, 24 weeks and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Duloxetine vs. Opioid in people with Total Knee Arthroplasty and 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 6 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 22 Jan 2021. 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. 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?
Contact Yong In, MD, PhD (82-10-9044-5228, iy1000@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Visual Analogue Scale (time frame: changes of the VAS score from the day before TKA operation and at postoperative 1, 2, 6, 12, 24th weeks and 1 year). 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 22 Jan 2021.