UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043813 |
|---|---|
| Receipt number | 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 06:19:11 |
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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
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
m.amr274@yahoo.com
Sponsor or person
Institute
Minia University, Faculty of medicine
anesthesia and intensive care department
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050011
