UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038854 |
|---|---|
| Receipt number | R000044277 |
| Scientific Title | Nalbuphine versus Magnesium Sulfate as an Adjuvant in Infraclavicular Brachial Plexus Block |
| Date of disclosure of the study information | 2020/12/09 |
| Last modified on | 2019/12/11 16:38:52 |
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Basic information
Public title
Nalbuphine versus Magnesium Sulfate as an Adjuvant in Ultrasound Infraclavicular Brachial Plexus Block: Efficacy and Postoperative Outcomes
Acronym
infraclav, MgSo4,Nalbu,
Scientific Title
Nalbuphine versus Magnesium Sulfate as an Adjuvant in Infraclavicular Brachial Plexus Block
Scientific Title:Acronym
Infraclav, MgSo4,Nalbu,
Region
| Africa |
Condition
Condition
Adjuvants to local anesthetics in infraclavicular block
Classification by specialty
| Aesthetic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To look the response of adding nalbuphine or magnesium sulfate as an adjuvant to bupivacaine on onset and duration of motor and sensory ultrasonic guided infraclavicular block
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assess the effect of nalbuphine and magnesium sulfate as an adjuvant to bupivacaine on onset and duration of motor and sensory infraclavicular 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
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group N where nalbuphine 20mg in 2ml added to 25ml bupivacaine 0.5%% (total volume 27 ml)
Interventions/Control_2
Group M as 150mg magnesium sulfate was added to 25ml bupivacaine 0.5% % (total volume 27 ml).
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
| 21 | years-old | <= |
Age-upper limit
| 62 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
After approval from the local ethical committee anesthesia department menoufia university Egypt, and patients informed consent, 60 adult patients aged from 20-60 years with ASA physical status classes I and II, scheduled for elective surgery in hands, wrist, and forearm.
Key exclusion criteria
patient refusal, or uncooperative patients, patient on anticoagulant therapy evidence of sever pulmonary, hepatic or renal disease, body mass index more than 35kg/m2,and history of brachial plexus injury and allergy to any of the drugs that will be used in the study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Wafiya |
| Middle name | R. |
| Last name | Mahdy |
Organization
Menofia University
Division name
Anesthesia department
Zip code
32511
Address
Faculty of medicine, Menofia University, Egypt
TEL
00201094245826
wafia.mahdi@med.menofia.edu.eg
Public contact
Name of contact person
| 1st name | Wafiya |
| Middle name | R |
| Last name | Mahdy |
Organization
Menofia University
Division name
Anesthesia department
Zip code
32511
Address
Faculty of medicine, Menofia University, Egypt
TEL
00201094245826
Homepage URL
wafia.mahdi@med.menofia.edu.eg
Sponsor or person
Institute
Faculty of medicine, Menofia University, Egypt
Institute
Department
Personal name
Funding Source
Organization
Faculty of medicine, Menofia University, Egypt
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
Faculty of medicine, Menofia University, Egypt
Address
Egyopt, Shebin El-Kom, Yassin Abdel Ghaffar street
Tel
00201094245826
wafia.mahdi@med.menofia.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
Anethesia department, Faculty of medicine, Menofia University, Egypt
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2019 | Year | 12 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 11 | Day |
Last modified on
| 2019 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044277
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| Registered date | File name |
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