UMIN-CTR Clinical Trial

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
Email	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
Email	wafia.mahdi@med.menofia.edu.eg

Sponsor
Institute	Faculty of medicine, Menofia University, Egypt
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044277