| CTRI Number |
CTRI/2023/09/058121 [Registered on: 29/09/2023] Trial Registered Prospectively |
| Last Modified On: |
27/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A RANDOMISED CLINICAL TRIAL TO COMPARE THE EFFICACY OF SINGLE INJECTION AND TRIPLE INJECTIONS USING A COSTOCLAVICULAR APPROACH FOR INFRACLAVICULAR BRACHIAL PLEXUS BLOCK FOR UPPER LIMB SURGERY |
|
Scientific Title of Study
|
A randomised clinical trial to compare the efficacy of single injection and triple injection using a Costoclavicular approach for infraclavicular brachial plexus block in upper limb surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyoti Mantur |
| Designation |
Senior Resident |
| Affiliation |
Shri B M Patil Medical College and Hospital |
| Address |
Department of Anaesthesiology,Shri B M Patil medical college,bangaramma sajjana campus,vijayapura karnataka Pin 586103
Bijapur
KARNATAKA
586103
India |
| Phone |
9740233176 |
| Fax |
|
| Email |
jotimantur23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VIDYA PATIL |
| Designation |
PROFESSOR |
| Affiliation |
Shri B M Patil Medical College and Hospital |
| Address |
Department of Anaesthesiology,Shri B M Patil medical college,bangaramma sajjana campus,vijayapura karnataka Pin 586103
Bijapur
KARNATAKA
586103
India |
| Phone |
|
| Fax |
|
| Email |
anaesthesia@bldedu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Jyoti Mantur |
| Designation |
Senior Resident |
| Affiliation |
Shri B M Patil Medical College and Hospital |
| Address |
Department of Anaesthesiology,Shri B M Patil medical college,bangaramma sajjana campus,vijayapura karnataka Pin 586103
Bijapur
KARNATAKA
586103
India |
| Phone |
9740233176 |
| Fax |
|
| Email |
jotimantur23@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri B M Patil Medical college hospital,Bangaramma sajjana campus,BLDE University,vijayapura,karnataka,pin 586103 centre,vijayapura,karnataka |
|
|
Primary Sponsor
|
| Name |
Shri B M Patil medicaal college hospital and Reaseach centre |
| Address |
Shri B M Patil Medical college hospital and Reseach centre,vijayapura,karnataka |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Jyoti Mantur |
Shri B M Patil Medical College and Hospital |
Deapartment of anaesthesiology,BLDE University,Bangaramma sajjan campus,vijayapur a,karnataka 586103
Bijapur
KARNATAKA |
9740233176
jotimantur23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, BLDE ( Deemed to be University ) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Costoclavicular Brachial Plexus Block under USG guidance with Ropivacaine |
Costoclavicular brachial plexus block is given by using 20ml of 0.5% Ropivacaine and 5ml of distilled water using single injection techniques under USG guidance . Block is given before starting the surgery and block is assessed for sensory and motor action 30 minutes after giving the block |
| Comparator Agent |
Costoclavicular brachial Plexus block using triple injection technique |
Costoclavicular brachial plexus block is given by using 20ml of 0.5% Ropivacaine and 5ml of distilled water using tripe injection techniques under USG guidance . Block is given before starting the surgery and block is assessed for sensory and motor action 30 minutes after giving the block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1)A.S.A. grades I and II
2)Age 18 to 55 years
3)Body mass index of 18-35 kgm2 |
|
| ExclusionCriteria |
| Details |
1)Cardio-cerebrovascular diseases (history of heart failure, poor control of hypertension, coronary heart disease and cerebrovascular history)
2)Respiratory insufficiency (More than four rib fractures, obstructive lung disease like emphysema, C.O.P.D. etc.)
3)Abnormal blood coagulation
4)Puncture site infection
5)Allergy to local anaesthetics |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate time to onset of Sensory and Motor block |
1 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to achieve complete sensory and motor blockade (i.e surgical anaesthesia)
Performance time
Duration of analgesia
Adverse events and complications (e.g., vascular puncture, pleural puncture, paraesthesia etc) |
24hours |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
15/10/2023 |
| 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="1"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
2 groups of patients were given Costoclavicular approach of brachial plexus block using 2 different techniques in each group. Time of onset of sensory and motor block was evaluated.Secondary outcomes include time to achieve complete sensory and motor block, performance time, duration of analgesia, adverse events and complications like vascular puncture, pleural puncture, paresthesia etc. Results of both the groups were monitored for block till 30 mins post surgery and for analgesia, till 24 hours. |