Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05254652 |
| Other study ID # |
KC22MISV0096 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2022 |
| Est. completion date |
May 2023 |
Study information
| Verified date |
April 2022 |
| Source |
The Catholic University of Korea |
| Contact |
Yong In, MD, PhD |
| Phone |
82-10-9044-5228 |
| Email |
iy1000[@]catholic.ac.kr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In this study, patients scheduled to undergo total knee arthroplasty (TKA) will be screened
through a survey for patients with central sensitivity and patients with neuropathic pain as
preoperative evaluation.
It is designed to evaluate the effectiveness of pregabalin with the decision to prescribe
duloxetine by dividing patient groups according to central sensitization and neuropathic
pain.
Description:
Screening for central sensitization and neuropathic pain will be performed two weeks in
advance of surgery for patients scheduled to undergo total knee arthroplasty, and is
performed through a central sensitization questionnaire and neuropathic pain survey. Through
the Central Sensitization Inventory, if the score is 40 or higher out of 100 points, it is
considered as the subject of central sensitization. And 13 or higher based on 38 points are
considered as the subject of neuropathic pain.
Among the patients who meet these two criteria, only those who agree to the study are
targeted. The same probability is assigned by a randomized table two weeks before surgery to
a group taking duloxetine and pregabalin and a group taking only duloxetine.
In the case of patients with central sensitization and neuropathic pain, both the
experimental group and the control group will take medicine for 10 weeks from 2 weeks before
surgery to 8 weeks after surgery. The experimental group takes one pill of duloxetine 30 mg,
one pill of pregabalin 150mg after breakfast and one pill of pregabalin 150 mg after dinner.
The control group takes only one pill of duloxetine 30 mg after breakfast.
A total of 10 weeks' worth of drugs will be provided two weeks before surgery, and medication
compliance will be evaluated based on the number of unused drugs returned by the test subject
when the drug is returned. In order to evaluate medication compliance, clinical trials should
record the number of drugs provided and returned at each visit and the discontinuation date.
Subjects must receive medication guidance on the drug-taking schedule. When the clinical
trial is completed or terminated in the middle, the unused or partially used drugs must be
returned to the clinical examiner and discarded after confirmation.
Relief drugs can also be taken up to six tablets a day, up to two tablets of 650 mg of
Tylenol ER Tablets(acetaminophen) once in both groups.
Anthropological information (gender, age, weight, height, body mass index) and outcome
variables (VAS scale for checking the degree of pain) are analyzed for the subjects of the
study among patients with central sensitization and neuropathic pain.
The subjects will be collected for three months after surgery in both the experimental group
and the control group, and the data will be organized and the results will be derived after
the last subject's three-month collection.
From immediately after surgery to three months after surgery, we will evaluate the side
effects complaining in the subject group. Side effects will be evaluated through interviews
with patients during outpatient visits. The above clinical evaluation is observed during the
daily treatment process, and the method performed in this clinical trial is judged to have no
unpredictable side effects during the current clinical process.
