UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized controlled trial compairing femoral nerve block and periarticular multimodal drug injection for anterior cruciate ligament reconstruction
Title of the study (Brief title)	A randomized controlled trial compairing femoral nerve block and periarticular multimodal drug injection for anterior cruciate ligament reconstruction
Region	Japan

Condition
Condition	Anterior cruciate ligament injury
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the femoral nerve block and periarticular multimodal drug injection for pain after anterior cruciate ligament reconstruction
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Post operative visual analog scale score at rest 24 hours after surgery.
Key secondary outcomes	Post operative visual analog scale score at rest until 14 days after surgery. The postoperative VAS scores for patient satisfaction with pain management until 3 days after surgery. The total amount of opioid consumption after surgery. Post operative complication.

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 Maneuver
Interventions/Control_1	A femoral nerve block for pain after anterior cruciate ligament reconstruction
Interventions/Control_2	A periarticular multimodal drug injection for pain after anterior cruciate ligament reconstruction
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	13 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Eligible patients were scheduled for primary ACL reconstruction with hamstring autograft, over 13 years old and had the ability to cooperate with data acquisition.
Key exclusion criteria	The exclusion criteria were revision ACL reconstruction, ACL reconstruction with bone-patellar tendon-bone graft, combined with other ligament reconstruction, combined with high tibial osteotomy, allergy to one of the study drugs, regular narcotic use, renal insufficiency, severe obesity (BMI > 35) and ECG abnormalities at rest.
Target sample size	120

Research contact person
Name of lead principal investigator	Shinichi Yoshiya
Organization	Hyogo College of Medicine
Division name	Orthopaedic surgery
Address	663-8501 1-1 Mukogawa-cho, Nishinomiya City, Hyogo, Japan
TEL	0798-45-6111
Email	yoshiya@hyo-med.ac.jp

Public contact
Name of contact person	Hiroshi Nakayama
Organization	Hyogo College of Medicine
Division name	Orthopaedic surgery
Address	663-8501 1-1 Mukogawa-cho, Nishinomiya City, Hyogo, Japan
TEL	0798-45-6111
Homepage URL
Email	hiroshi0273@mac.com

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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 05 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 15 Day
Anticipated trial start date	2013 Year 09 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.arthroscopyjournal.org/article/S0749-8063(17)31173-8/pdf
Results
Other related information

Management information
Registered date	2014 Year 05 Month 19 Day
Last modified on	2017 Year 12 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016192