UMIN-CTR Clinical Trial

Basic information
Public title	Comparision of Anesthetic drug combinations Bupivacaine with clonidine and Levobupivacaine with clonidine used in nerve blocks for surgeries of upper limb
Acronym	Comparision of Anesthetic drug combinations Bupivacaine with clonidine and Levobupivacaine with clonidine used in nerve blocks for surgeries of upper limb
Scientific Title	A PROSPECTIVE RANDOMIZED CLINICAL STUDY TO COMPARE THE EFFICACY OF 0.25% BUPIVACAINE WITH CLONIDINE AND 0.25% LEVOBUPIVACAINE WITH CLONIDINE IN SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK FOR UPPER LIMB SURGERIES
Scientific Title:Acronym	A PROSPECTIVE RANDOMIZED CLINICAL STUDY TO COMPARE THE EFFICACY OF 0.25% BUPIVACAINE WITH CLONIDINE AND 0.25% LEVOBUPIVACAINE WITH CLONIDINE IN SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK FOR UPPER LIMB SURGERIES
Region	Asia(except Japan)

Condition
Condition	ANAESTHESIA FOR UPPER LIMB SURGERIES
Classification by specialty	Anesthesiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The effects will be studied in 2 groups in terms of 1.Onset and duration of sensory block 2.Onset and duration of motor block 3.Hemodynamic changes 4.Assessment of pain 5.Adverse effects if any
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase IV

Assessment
Primary outcomes	Measure the Onset and duration of action between combination of 0.25% Bupivacaine with Clonidine and 0.25% Levobupivacaine with Clonidine in Supraclavicu;ar Brachial plexus block for upper limb surgeries. Onset was measured every minute after giving supraclavicular brachial plexus block Duration was measured until complete recovery from supraclavicular brachial plexus block using Bromage scale
Key secondary outcomes	1. Hemodynamic changes mainly systolic blood pressure, diastolic blood pressure, Mean arterial blood pressure and Peripheral oxygen saturation SpO2 are measured Intraoperatively every 5 minutes and Postoperatively every hourly upto 24 hours between the study groups 2.Postoperative Assessment of pain with the use of Visual analogue scale was measured every hourly upto 24 hours. 3. Occurance of any adverse events were notes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Dose comparison
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Group BC: recieved 30 ml of 0.25% Bupivacaine with 1microgram/kg Clonidine for supraclavicular brachial plexus block for upper limb surgeries
Interventions/Control_2	Group LC: recieved 30 ml of 0.25% Levoupivacaine with 1microgram/kg Clonidine for supraclavicular brachial plexus block for upper limb surgeries
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	18 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Patients aged between 18 to 60 years of either sex. 2.ASA physical status I-II 3.Elective upper limb surgeries
Key exclusion criteria	1.Patient refusal for procedure 2.Any bleeding disorder or patient on anticoagulants 3.Neurological deficits involving brachial plexus 4.Patients with allergy to local anaesthetics 5.Local infection at the injection site 6.Patients on any adrenoreceptor agonist or antagonist therapy 7.Patients weighing less than 35kgs 8.Body mass index >35 9.Pregnant women
Target sample size	80

Research contact person
Name of lead principal investigator	1st name ABHISHEK Middle name Last name R
Organization	K.V.G. MEDICAL COLLEGE AND HOSPITAL
Division name	DEPARTMENT OF ANAESTHESIOLOGY
Zip code	574327
Address	KURUNJIBAG, SULLIA,DK
TEL	08257232404
Email	kvgmedc@yahoo.com

Public contact
Name of contact person	1st name ABHISHEK Middle name Last name R
Organization	K.V.G. MEDICAL COLLEGE AND HOSPITAL
Division name	DEPARTMENT OF ANAESTHESIOLOGY
Zip code	574327
Address	KURUNJIBAG, SULLIA,DK
TEL	7795098801
Homepage URL
Email	drabhishekservices@gmail.com

Sponsor
Institute	K.V.G. MEDICAL COLLEGE AND HOSPITAL DEPARTMENT OF ANAESTHESIOLOGY
Institute
Department

Funding Source
Organization	K.V.G. MEDICAL COLLEGE AND HOSPITAL DEPARTMENT OF ANAESTHESIOLOGY
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	K.V.G. MEDICAL COLLEGE AND HOSPITAL
Address	KURUNJIBAG- 574327, SULLIA, DK
Tel	08257232404
Email	kvgmedc@yahoo.com

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 04 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	80
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	Completed
Date of protocol fixation	2013 Year 11 Month 12 Day
Date of IRB	2013 Year 11 Month 22 Day
Anticipated trial start date	2013 Year 12 Month 01 Day
Last follow-up date	2020 Year 06 Month 10 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 06 Month 04 Day
Last modified on	2021 Year 06 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050766