UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049288 |
|---|---|
| Receipt number | R000056130 |
| Scientific Title | Postoperative pain management in anterior cruciate ligament reconstruction and around the knee osteotomy |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2022/10/21 15:23:14 |
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Basic information
Public title
Postoperative pain management in anterior cruciate ligament reconstruction and around the knee osteotomy
Acronym
Postoperative pain management in ACLR and AKO
Scientific Title
Postoperative pain management in anterior cruciate ligament reconstruction and around the knee osteotomy
Scientific Title:Acronym
Postoperative pain management in ACLR and AKO
Region
| Japan |
Condition
Condition
Anterior cruciate ligament injury, knee osteoarthritis
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the need for intravenous fentanyl in the management of post-operative pain
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analgesia score (Numerical rating scale)
Dietary intake the day after surgery
Key secondary outcomes
Side effects (nausea and vomiting)
Requirement of pain relief
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are 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
Intravenous acetaminophen and fentanyl
Intravenous fentanyl is not increased or decreased by time 1 CC and discontinued if there is a second vomiting episode; 1000 mg acetaminophen IV immediately after surgery and after 5, 10 and 15 hours.
Interventions/Control_2
Intravenous acetaminophen
1000 mg acetaminophen IV immediately after surgery and after 5, 10 and 15 hours.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Patients undergoing anterior cruciate ligament reconstruction (regardless of meniscus procedure)
2 Patients undergoing high tibial osteotomy for internal knee osteoarthritis
Key exclusion criteria
1 Compound ligament injuries Reconstruction for re-injury
2 External knee Osteotomy on femoral side Multiple operations such as ligament reconstruction
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shunichiro |
| Middle name | |
| Last name | Kambara |
Organization
Nishinomiya Kaisei hospital
Division name
Orthopaedic
Zip code
662-1145
Address
1-4, Oohamacho, Nishinomiya city, Hyogo
TEL
0798-33-0601
shunkazu19810723@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Shunichiro |
| Middle name | |
| Last name | Kambara |
Organization
Nishinomiya Kaisei hospital
Division name
Orthopaedic
Zip code
662-1145
Address
1-4, Oohamacho, Nishinomiya city, Hyogo
TEL
0798-33-0601
Homepage URL
shunkazu19810723@hotmail.co.jp
Sponsor or person
Institute
Nishinomiya Kaisei hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nishinomiya Kaisei hospital
Address
1-4, Oohamacho, Nishinomiya city, Hyogo
Tel
0798-33-0601
shunkazu19810723@hotmail.co.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
| 2022 | Year | 11 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2022 | Year | 10 | Month | 21 | Day |
Last modified on
| 2022 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056130
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
