UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044438 |
|---|---|
| Receipt number | R000050766 |
| 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 |
| Date of disclosure of the study information | 2021/06/04 |
| Last modified on | 2021/06/04 21:14:47 |
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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
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
drabhishekservices@gmail.com
Sponsor or person
Institute
K.V.G. MEDICAL COLLEGE AND HOSPITAL
DEPARTMENT OF ANAESTHESIOLOGY
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050766
