UMIN-CTR Clinical Trial

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
Email	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
Email	shunkazu19810723@hotmail.co.jp

Sponsor
Institute	Nishinomiya Kaisei hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056130