UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analgesic effects of sciatic nerve blockade with additional of dexamethasone to local anesthetic: a prospective randomized controlled study in patients after anterior cruise ligament reconstruction surgery
Title of the study (Brief title)	Analgesic effects of sciatic nerve blockade with additional of dexamethasone to local anesthetic: a prospective randomized controlled study in patients after anterior cruise ligament reconstruction surgery
Region	Japan

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

Objectives
Narrative objectives1	To verify the analgesic effects of additional of a small amount of dexamethasone to local anesthetic for sciatic nerve block in patients after anterior cruciate ligament reconstruction surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time from block to patients feel pain
Key secondary outcomes	Visual analogue pain scores at rest and while movement at 24, 48h after operation Maxium pain score and the time after block Time from block to recovery of the motion of the ankle joint Time when the patients used analgesics Neurological involvement Troubles related to catheter

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved 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	Additional of dexamethasone 3.3 mg to local anesthetics used for sciatic nerve block
Interventions/Control_2	Only local anesthetics are used for sciatic nerve block
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	Patients who schedulled for anterior cruciate ligament reconstruction surgery under peripheral nerve blocks American Society of Anesthesiologists physical status 1-2
Key exclusion criteria	Neuropathy on the surgical site Preoperative use of opiate analgesics Allergy to medications used for study
Target sample size	22

Research contact person
Name of lead principal investigator	Shinichi Sakura
Organization	Shimane University Hospital
Division name	Operation department
Address	89-1 Ennyacho, Izumo-city, Shimane, Japan
TEL	0853-20-2295
Email	ssakura@med.shimane-u.ac.jp

Public contact
Name of contact person	Shinichi Sakura
Organization	Shimane University Hospital
Division name	Operation department
Address	89-1 Ennyacho, Izumo-city, Shimane, Japan
TEL	0853-20-2295
Homepage URL
Email	ssakura@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University Faculty of Medicine
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)

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	2017 Year 09 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 28 Day
Anticipated trial start date	2017 Year 09 Month 04 Day
Last follow-up date	2018 Year 06 Month 07 Day
Date of closure to data entry	2018 Year 06 Month 07 Day
Date trial data considered complete	2018 Year 06 Month 07 Day
Date analysis concluded	2018 Year 06 Month 07 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	The addition of dexamethasone 3.3mg perineural to subgluteal SNB using 0.5% ropivacaine prolonged the duration of sensory and motor blockade in patients undergoing anterior cruciate ligament reconstruction. No complication was observed.
Other related information

Management information
Registered date	2017 Year 08 Month 31 Day
Last modified on	2018 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033106