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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000014624
Receipt No. R000015955
Scientific Title Effects of postoperative administration of celecoxib on postoperative pain management in patients after total knee arthroplasty. A randomized controlled study.
Date of disclosure of the study information 2014/07/23
Last modified on 2019/01/27

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Basic information
Public title Effects of postoperative administration of celecoxib on postoperative pain management in patients after total knee arthroplasty. A randomized controlled study.
Acronym EPOCA
Scientific Title Effects of postoperative administration of celecoxib on postoperative pain management in patients after total knee arthroplasty. A randomized controlled study.
Scientific Title:Acronym EPOCA
Region
Japan

Condition
Condition Osteoarthritis, Rheumatoid arthritis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of postoperative administration of celecoxib on postoperative pain after TKA surgery, compared with no administration of celecoxib with femoral and sciatic nerve blocks and PCA fentanyl.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes VAS pain score on the second day after TKA
Key secondary outcomes 1. Fentanyl consumption through PCA
2. VAS pain score through the following day to the seventh day after surgery
3. Range of motion of the knee joint
4. Evaluation of sleep quality using VAS sleep disturbance
5. Evaluation of sleep quality including sleep latency, sleep efficacy, nocturnal awakening, sleep depth, body motion and the time it takes to deep sleep monitored by SLEEPSCAN.
6. The overall patient satisfaction during the period of medication.
7. The overall evaluation by physician during the period of medication.
8. Incidence rate of postoperative nausea and vomiting, and frequency of taking anti-nausea pills
9. Rescue analgesic consumption (a diclofenac sodium suppository) after the removal of PCA fentanyl.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of celecoxib from 2 hours after TKA surgery
Interventions/Control_2 Administration of celecoxib from 2 days after TKA surgery
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patient can understand and comply with the protocol and has signed the informed consent document at screening.
2) Patient is over 20 years old at the time of informed consent.
3) Patient undergoing unilateral total knee arthroplasty
4) Patient undergoing TKA surgery in the morning
5) Patient assessed by principal and/or co-investigator for eligibility as pain control with multimodal analgesia including femoral and sciatic nerve blocks and PCA fentanyl after TKA surgery.
Key exclusion criteria 1) Patient who has a history or complication of hypersensitivity to celecoxib, fentanyl or sulfonamides, and patient who has a history or complication of a serious allergic reaction to any other drugs.
2) Patient who has a history or complication with aspirin-induced asthma.
3) Patient who has a complication of gastrointestinal hemorrhage or ulcer.
4) Patient who has severe hepatic dysfunction.
5) Patient who has severe renal dysfunction.
6) Patient who has severe cardiovascular dysfunction.
7) Patient who is in a perioperative period of coronary artery bypass surgery.
8) Patient who is pregnant, lactating or probably pregnant.
9) Patient who had a drug abuse.
10) Patient who takes or will take an analgetic drug or sleeping drug with the exception of the following drugs from two days before surgery to final evaluation.
Ultrashort- acting Hypnotic including triazolam, zopiclone and zolpidem tartrate is permitted until surgery.
11) Patient who is judged not to carry the trial through by principal or co-investigator.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeo Mammoto
Organization Mito medical center, Mito Kyodo General Hospital, University of Tsukuba
Division name Department of Orthopaedic Surgery and Sports Medicine
Zip code
Address 3-2-7 Miya-Machi, Mito Ibarakii, Japan
TEL 029-231-2371
Email mammototakeo@mitokyodo-hp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeo Mammoto
Organization Mito medical center, Mito Kyodo General Hospital, University of Tsukuba
Division name Department of Orthopaedic Surgery and Sports Medicine
Zip code
Address 3-2-7 Miya-Machi, Mito Ibarakii, Japan
TEL 029-231-2371
Homepage URL
Email mammototakeo@mitokyodo-hp.jp

Sponsor
Institute Mito medical center, Mito Kyodo General Hospital, University of Tsukuba
Institute
Department

Funding Source
Organization Pfizer Japan Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 07 Month 23 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2014 Year 03 Month 11 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 01 Day
Last follow-up date
2016 Year 12 Month 31 Day
Date of closure to data entry
2017 Year 04 Month 20 Day
Date trial data considered complete
2017 Year 04 Month 21 Day
Date analysis concluded
2017 Year 06 Month 23 Day

Other
Other related information

Management information
Registered date
2014 Year 07 Month 23 Day
Last modified on
2019 Year 01 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015955

Research Plan
Registered date File name
2016/07/25 EPOCA protocol paper.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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