UMIN-CTR Clinical Trial

Basic information
Public title	dexamethasone in supraclavicular brachial plexus block
Acronym	dexamethasone in supraclavicular brachial plexus block
Scientific Title	Bupivacaine- lidocaine versus bupivacaine- lidocaine plus dexamethasone in supraclavicular brachial plexus block
Scientific Title:Acronym	Bupivacaine- lidocaine versus bupivacaine- lidocaine plus dexamethasone in supraclavicular brachial plexus block:dexamethasone in supraclavicular brachial plexus block
Region	Africa

Condition
Condition	regional block
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate whether dexamethasone as an adjuvant to bupivacaine - lidocaine mixture in supraclavicular brachial plexus block can enhance the block, prolong the duration of action and improve postoperative analgesia than mixture of bupivacaine - lidocaine only
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Onset time of sensory and motor block, duration of sensory and motor block
Key secondary outcomes

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	Maneuver
Interventions/Control_1	received 40 mL solution containing local anesthetics only
Interventions/Control_2	received 40 mL solution containing local anesthetics plus 4mg dexamethasone
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	17 years-old <
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	American Society of Anesthesiologists (ASA) physical status I, II, and III patients undergoing upper limb surgery either elective or emergent.
Key exclusion criteria	patient refusal, patients with damage or disease of the brachial plexus, any bleeding disorder, on anticoagulants, neuromuscular diseases, peripheral neuropathy, local skin infection at the site of injection, or history of allergy to any of the studied drugs
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Amr Middle name Nady Last name abdelrazik
Organization	Minia University, Faculty of medicine
Division name	anesthesia and intensive care department
Zip code	61768
Address	Minya Elgedida
TEL	00201023451177
Email	m.amr274@yahoo.com

Public contact
Name of contact person	1st name Amr Middle name Nady Last name abdelrazik
Organization	Minya University,Faculty of medicine
Division name	anesthesia and intensive care department
Zip code	61768
Address	Minya Elgedida
TEL	00201023451177
Homepage URL
Email	m.amr274@yahoo.com

Sponsor
Institute	Minia University, Faculty of medicine anesthesia and intensive care department
Institute
Department

Funding Source
Organization	Minia University, Faculty of medicine anesthesia and intensive care department
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Minya University
Address	Minya Elgedida
Tel	00862366100
Email	sara.mohamed@mu.edu.eg

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	2021 Year 06 Month 01 Day

Related information
URL releasing protocol	http://www.editorialmanager.com:10161/pcorm/
Publication of results	Unpublished

Result
URL related to results and publications	http://www.editorialmanager.com:10161/pcorm/,
Number of participants that the trial has enrolled	60
Results	the addition of dexamethasone as an adjuvant to local anesthetics results in prolonged duration of sensory block, motor block, and prolonged duration of postoperative analgesia compared to local anesthetics alone. We found that it has no effect on the onset time of sensory and motor blocks.
Results date posted	2021 Year 04 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	There were no statistically significant differences between the two groups as regards age, sex ratio, weight, height, ASA classification, and surgery duration
Participant flow	60 participant
Adverse events	No adverse effects related to the drugs used in the technique or related to the technique itself were observed in both groups at any time during the whole period of the study except for local hematoma
Outcome measures	There were statistically significant differences between the two groups as regards to the duration of sensory and motor blocks. Group C was significantly shorter in sensory duration
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 01 Day
Date of IRB	2015 Year 03 Month 06 Day
Anticipated trial start date	2015 Year 05 Month 01 Day
Last follow-up date	2015 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 04 Month 01 Day
Last modified on	2021 Year 06 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050011