UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040026 |
|---|---|
| Receipt number | R000045630 |
| Scientific Title | Effect of duloxetine on postoperative pain after high tibial osteotomy: a randomized controlled trial |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2026/07/25 16:20:27 |
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Basic information
Public title
Effect of duloxetine on postoperative pain after high tibial osteotomy: a randomized controlled trial
Acronym
Effect of duloxetine on postoperative pain after high tibial osteotomy: a randomized controlled trial
Scientific Title
Effect of duloxetine on postoperative pain after high tibial osteotomy: a randomized controlled trial
Scientific Title:Acronym
Effect of duloxetine on postoperative pain after high tibial osteotomy: a randomized controlled trial
Region
| Japan |
Condition
Condition
knee osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of duloxetine on postoperative pain after high tibial osteotomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain VAS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Control
Interventions/Control_2
Duloxetine for postoperative 3 months
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing high tibial osteotomy for knee osteoarthritis
Key exclusion criteria
patients who took duloxetine within 1 month.
Target sample size
82
Research contact person
Name of lead principal investigator
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Ogawa |
Organization
Ogaki Tokushukai Hospital
Division name
Orthopaedic Surgery
Zip code
503-0015
Address
Hyashi-machi 6-85-1, Ogaki, Gifu, Japan
TEL
0584-77-6110
hiroyasu.ogawa@tokushukai.jp
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Ogawa |
Organization
Ogaki Tokushukai Hospital
Division name
Orthopaedic Surgery
Zip code
503-0015
Address
Hyashi-machi 6-85-1, Ogaki, Gifu, Japan
TEL
0584-77-6110
Homepage URL
hiroyasu.ogawa@tokushukai.jp
Sponsor or person
Institute
Ogaki Tokushukai Hospital
Institute
Department
Personal name
Funding Source
Organization
Ogaki Tokushukai Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
miraiiryokenkyucenter
Address
eminabuilding3F kouji-mati 1-8-7, tiyoda-ku, tokyo
Tel
03-3263-4801
mirai-ec1@mirai-iryo.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.umin.ac.jp/ctr/index.htm
Publication of results
Published
Result
URL related to results and publications
https://journals.sagepub.com/doi/10.1177/10225536261437327?url_ver=Z39.88-2003&rfr_id=ori:rid:crossr
Number of participants that the trial has enrolled
75
Results
Thirty-eight patients in the duloxetine group and 37 in the control group were analyzed. Duloxetine significantly reduced pain at rest at 6 months postoperatively and acetaminophen consumption during the third postoperative week, although no differences were observed in other outcomes. Overall, duloxetine provided only a modest analgesic benefit after HTO, and routine postoperative use cannot be recommended.
Results date posted
| 2026 | Year | 07 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Eligible patients were aged over 40 years and scheduled to undergo primary unilateral HTO for KOA, osteonecrosis, or subchondral insufficiency fracture of the knee.15 Exclusion criteria were patients with prior duloxetine use within 1 month of consent for this clinical trial, American Society of Anesthesiologists class IV or higher, myocardial infarc- tion, psychiatric or organic brain disorders, a history of coronary artery disease, unstable angina, heart failure, kidney failure, hepatic failure, pregnancy, breastfeeding, poorly controlled angle-closure glaucoma, intolerance or allergy to study drugs, administration of monoamine oxi- dase inhibitors within 2 weeks before enrolment, aspirin- induced asthma, or patients who would be unable to undergo 3 weeks of post-operative rehabilitation and take medication while hospitalized.
Participant flow
Patients were randomised into either the control or du- loxetine group using a computerised, random allocation by a clinician not involved in the clinical analysis.
The basic examination items included age, sex, body mass index, the presence or absence of NP and central sensitisation (CS), and radiographic examination (Kellgren Lawrance grade and Hip knee ankle angle).16 Possible NP was defined as PainDETECT over 14 points and CS was defined as Central sensitization index over 40 points.
Adverse events
In the duloxetine group, one adverse event
Outcome measures
The primary outcome was pain at rest and during motion, assessed by two independent physiotherapists preopera- tivelyandat,and5days;,and3weeks;and2,3,and 6 months postoperatively, using rVAS and mVAS (scores 0 to 10, with 0 indicating no pain and 10 indicating the most severe pain). Secondary pain outcomes included the Brief Pain Inventory (BPI; pain severity and interference scores) assessed at the same time points.21 Secondary outcomes measures included the Knee Society Score (KSS; knee and
function scores) and the 2011 Knee Society Score (KSS2011) recorded preoperatively and at 6 months post- operatively,22 acetaminophen consumption, and adverse events related to duloxetine, as reported by the drug manufacturer.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 07 | Month | 25 | Day |
Date trial data considered complete
| 2026 | Year | 07 | Month | 25 | Day |
Date analysis concluded
| 2026 | Year | 07 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 01 | Day |
Last modified on
| 2026 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045630
