CTRI

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CTRI Number

CTRI/2021/12/038711 [Registered on: 17/12/2021] Trial Registered Prospectively

Last Modified On:

14/12/2021

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Surgical/Anesthesia

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

To Know the efficacy between supraclavicular and infraclavicular block under ultrasound

Scientific Title of Study

ULTRASOUND GUIDED SUPRACLAVICULAR VERSUS INFRACLAVICULAR BRACHIAL PLEXUS BLOCK:A RANDOMIZED CONTROL TRIAL

Trial Acronym

USG SUPRACLAVICULAR INFRACLAVICULAR

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Ratikanta sahoo
Designation	2nd year PG Anaesthesia
Affiliation	Veer Surendra Sai Institute Of Medical Science and Research
Address	Department of Anaesthesiology and critical care vimsar, burla samablpur orissa 768017 Sambalpur ORISSA 768017 India
Phone	9439465419
Fax
Email	cool.drrati25@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Pradipta kumar Patel
Designation	Associate Professor ,Department of anaesthesiology and critical care,VIMSAR BURLA
Affiliation	Department of anaesthesiology and critical care,VIMSAR BURLA
Address	Department of anaesthesiology and critical care vimsar,burla samablpur , orissa Sambalpur ORISSA 768017 India
Phone	9437062284
Fax
Email	patelpradipta@gmail.com

Details of Contact Person
Public Query

Name	Dr Pradipta kumar Patel
Designation	Associate Professor ,Department of anaesthesiology and critical care,VIMSAR BURLA
Affiliation	Department of anaesthesiology and critical care,VIMSAR BURLA
Address	Department of anaesthesiology and critical care vimsar,burla samablpur , orissa ORISSA 768017 India
Phone	9437062284
Fax
Email	patelpradipta@gmail.com

Source of Monetary or Material Support

Department of anaesthesiology and critical care , VIMSAR, burla

Primary Sponsor

Name	Veer Surendra Sai Institute of Medical Science and Research
Address	Department of Anaesthesiology and critical care , VIMSAR , Burla
Type of Sponsor	Government medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Ratikanta Sahoo	Veer Surendra Sai Institute of Medical Science and Research	Orthopaedics Operation Theatre, vimsar burla Sambalpur ORISSA	9439465419 cool.drrati25@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTIONAL RESEARCH AND ETHICS COMMITTEE , VEER SURENDRA SAI INSTITUTE OF MEDICAL SCIENCE AND RESEARCH	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: O\|\|Medical and Surgical, (2) ICD-10 Condition: O\|\|Medical and Surgical,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Ultrasound guided Infraclavicular block	Ultrasound guided Infraclavicular approach of brachial plexus block will be performed in Group B Patients with 20 ml 0.5% Bupivacaine
Intervention	Ultrasound guided supraclavicular approach	Ultrasound guided supraclavicular approach of brachial plexus block will be performed in Group A patients with 20 ml Bupivacaine 0.5%

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	ASA GRADEI AND GRADEII AGE 18-60 YEAR OF BOTH SEX UNDERGOING FOREARM SURGERIES

ExclusionCriteria

Details

1.)PATIENTS WITH HISTORY OF ALLERGY TO LOCAL ANAESTHESIA.
2.) PATIENTS WITH BLEEDING DISORDER
3.)PATIENT WITH PSYCHIATRIC DISORDER
4.) PATIENT WITH NEURO MUSCULAR DISORDER

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

An Open list of random numbers

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
As compared to supraclavicular approach ,Infraclavicular approach of brachial plexus block for upper limb surgeries might have a better or equal surgical effectiveness,fewer adverse events and faster onset of action.	As compared to supraclavicular approach ,Infraclavicular approach of brachial plexus block for upper limb surgeries might have a better or equal surgical effectiveness,fewer adverse events and faster onset of action.

Secondary Outcome

Outcome	TimePoints
Adverse effects,Post operative pain	Within 10 hours after brachial plexus block

Target Sample Size

Total Sample Size="166"
Sample Size from India="166"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

29/12/2021

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="0"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

NIL

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Ultrasound guided spraclavicular and infraclavicular approach of brachial plexus block was performed in two groups.Drug bupivacaine 0.5% 20 ml was used.This study was perfomed to compare between ultrasound guided supraclavicular block and infraclavicular block in term of onset,duration,efficacy and conversion rate to general anaesthesia,need of adjuvant drugs,complications,hemodynamic parameters.