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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043813
Receipt No. R000050011
Scientific Title Bupivacaine- lidocaine versus bupivacaine- lidocaine plus dexamethasone in supraclavicular brachial plexus block
Date of disclosure of the study information 2021/06/01
Last modified on 2021/06/09

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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