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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000044438
Receipt No. 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

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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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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