| CTRI Number |
CTRI/2021/04/032547 [Registered on: 05/04/2021] Trial Registered Prospectively |
| Last Modified On: |
04/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study is to compare efficacy of two different approaches that block the brachial plexus to see the motor and sensory blockade and to assess the tourniquet pain. |
|
Scientific Title of Study
|
“COMPARISON BETWEEN ULTRASOUND GUIDED SUPRACLAVICULAR AND INFRACLAVICULAR BRACHIAL PLEXUS BLOCK TO ASSESS THE QUALITY OF SURGICAL ANAESTHESIA AND INTRAOPERATIVE TOURNIQUET PAIN:PROSPECTIVE RANDOMISED OBSERVER BLINDED STUDY†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
B SAI SUSMITHA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE,KAHER |
| Address |
Department of Anaesthesiology,2nd floor,KLE Dr Prabhakar Kore Hospital,Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9000634346 |
| Fax |
|
| Email |
sushmithabrl16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahantesh S Mudakangoudar |
| Designation |
Associate professor |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE,KAHER |
| Address |
Department of Anaesthesiology,2nd floor,KLE DR PRABHAKAR KORE HOSPITAL JNMC NEHRU NAGAR BELAGAVI
Belgaum
KARNATAKA
590010
India |
| Phone |
7829164500 |
| Fax |
|
| Email |
drmontygoudar@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
B SAI SUSMITHA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE,KAHER |
| Address |
Department of Anasthesiology,Kle Dr Prabhakar Kore Hospital,Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9000634346 |
| Fax |
|
| Email |
sushmithabrl16@gmail.com |
|
|
Source of Monetary or Material Support
|
| SELF and KLEs Dr Prabhakar Kore charitable Hospital and Medical Research Centre |
|
|
Primary Sponsor
|
| Name |
at KLEs Dr Prabhakar Kore charitable Hospital and Medical Research Centre |
| Address |
JNMC NEHRU NAGAR BELGAVI |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr B Sai Susmitha |
KLES DR. PRABHAKAR KORE HOSPITAL AND MEDICAL RESEARCH CENTRE |
Department of Anaesthesiology,2nd floor,Kles Dr Prabhakar Kore Hospital,Belagavi
Belgaum
KARNATAKA |
9000634346
sushmithabrl16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTEE ON HUMAN SUBJECTS RESEARCH |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
Ultrasound guided brachial plexus block |
Using Ultrasound we compare supraclavicular brachial plexus block with infraclavicular brachial plexus block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologist(ASA) physical status I to II
Age between 18 to 60 years.
Patients undergoing elective surgeries of upper limb under Ultrasound guided Supraclavicular or Infraclavicular Brachial plexus block.
Patients with BMI less than 30.
Provides Consent.
|
|
| ExclusionCriteria |
| Details |
Patients undergoing emergency surgeries.
Patients with coexisting lung diseases, pregnancy.
Allergy to Local Anaesthetics
Chest deformities
Previous Clavicular fractures.
Neurological deformities.
Patients who do not fulfill inclusion criteria
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of sensory and motor blockade in terminal nerves of brachial plexus and tourniquet pain in ultrasound guided supraclavicular and infraclavicular brachial plexus |
Baseline after 10 mins half an hour and every 10mins till the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of duration of block,block performance time and intraoperative and postoperative complications in ultrasound guided supraclavicular and infraclavicular block. |
Duration of motor and sensory blockade is seen |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
15/04/2021 |
| 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="1"
Months="0"
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
|
This study mainly focuses on advantages of ultrasound guided infraclavicular brachial plexus block over supraclavicular brachial plexus with respect sensory and motor block,tourniquet pain and complications. |