UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Dexamethasone as adjunct to local anesthetic in brachial plexus nerve block for shoulder surgery
Title of the study (Brief title)	Dexamethasone as adjunct to local anesthetic in brachial plexus nerve block for shoulder surgery
Region	Japan

Condition
Condition	Surgical patients received arthroscopic rotator cuff repair
Classification by specialty	Orthopedics Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of the study is to determine effect of dexamethasone in brachial plexus nerve block.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Analgesic duration after brachial plexus block
Key secondary outcomes	Numbers of additional analgesic after surgery; Duration of numbness after brachial plexus block

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Surgical patients received arthroscopic rotator cuff repair
Key exclusion criteria	None
Target sample size	140

Research contact person
Name of lead principal investigator	Shigekazu Sugino
Organization	Tohoku University
Division name	Department of Anesthesiology and Perioperative Medicine
Address	2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL	0227177321
Email	sugino@ruby.ocn.ne.jp

Public contact
Name of contact person	Tsutomu Iwakawa
Organization	Tohoku Rosai Hospital
Division name	Department of Anesthesia
Address	3-21, Dainohara 4, Aoba-ku, Sendai, Miyagi 981-8563, Japan
TEL	0222751111
Homepage URL
Email	to48mutsu@gmail.com

Sponsor
Institute	Tohoku University
Institute
Department

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)

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	2016 Year 11 Month 16 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 10 Month 10 Day
Anticipated trial start date	2016 Year 11 Month 14 Day
Last follow-up date
Date of closure to data entry	2017 Year 03 Month 01 Day
Date trial data considered complete	2017 Year 03 Month 01 Day
Date analysis concluded	2017 Year 04 Month 04 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	The present results showed that addition of dexamethsone to local anesthetics was significant factor for a relief of postsurgical shoulder pain. This effect of dexamethsone produced 5 hours longer duration of analgesia.
Other related information	We analyzed 112 patients in the current study.

Management information
Registered date	2016 Year 11 Month 15 Day
Last modified on	2017 Year 05 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028603