UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039116 |
|---|---|
| Receipt number | R000044407 |
| Scientific Title | Effects of zolpidem tartrate on Postoperative Pain in patients after total knee arthroplasty. A randomized controlled study. |
| Date of disclosure of the study information | 2020/01/15 |
| Last modified on | 2024/01/13 09:17:51 |
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Basic information
Public title
Effects of Sleep Management on Postoperative Pain in patients after total knee arthroplasty. A randomized controlled study.
Acronym
SMAPP
Scientific Title
Effects of zolpidem tartrate on Postoperative Pain in patients after total knee arthroplasty. A randomized controlled study.
Scientific Title:Acronym
SMAPP
Region
| Japan |
Condition
Condition
Osteoarthritis, Rheumatoid arthritis
Classification by specialty
| Orthopedics | Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of postoperative administration of zolpidem tartrate on postoperative pain after TKA surgery, compared with no administration of zolpidem tartrate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
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 sleep monitor.
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.
Study
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 zolpidem tartrate of 5mg for 7 days after surgery
Interventions/Control_2
No administration of zolpidem tartrate
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 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 is judged not to carry the trial through by principal or co-investigator.
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | Takeo |
| Middle name | |
| Last name | Mammoto |
Organization
Mito medical center, Mito Kyodo General Hospital, University of Tsukuba
Division name
Department of Orthopaedic Surgery and Sports Medicine
Zip code
3100015
Address
3-2-7 Miya-Machi, Mito Ibarakii, Japan
TEL
029-231-2371
mammototakeo@mitokyodo-hp.jp
Public contact
Name of contact person
| 1st name | Takeo |
| Middle name | |
| Last name | Mammoto |
Organization
Mito medical center, Mito Kyodo General Hospital, University of Tsukuba
Division name
Department of Orthopaedic Surgery and Sports Medicine
Zip code
3100015
Address
3-2-7 Miya-Machi, Mito Ibarakii, Japan
TEL
029-231-2371
Homepage URL
mammototakeo@mitokyodo-hp.jp
Sponsor or person
Institute
Mito medical center, Mito Kyodo General Hospital, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Mito medical center, Mito Kyodo General Hospital, University of Tsukuba
Address
3-2-7 Miya-Machi, Mito Ibarakii, Japan
Tel
029-231-2371
clark@mitokyodo-hp.jp
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 | 01 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 10 | Day |
Last modified on
| 2024 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044407
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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