| CTRI Number |
CTRI/2024/02/063293 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
25/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparing two different types of upper limb blocks in clavicle surgeries |
|
Scientific Title of Study
|
Comparison of block onset and post operative analgesia between supraclavicular upper trunk block versus interscalene block in clavicle surgeries: A prospective observation study in a tertiary care hospital in mandya |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivakumar G |
| Designation |
Professor and HOD |
| Affiliation |
Mandya institute of medical sciences |
| Address |
Department of Anaesthesiology
Mandya institute of medical sciences
Mandya
Mandya
KARNATAKA
571401
India |
| Phone |
9900468451 |
| Fax |
|
| Email |
dranashiv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivakumar G |
| Designation |
Professor and HOD |
| Affiliation |
Mandya institute of medical sciences |
| Address |
Department of Anaesthesiology
Mandya institute of medical sciences
Mandya
KARNATAKA
571401
India |
| Phone |
9900468451 |
| Fax |
|
| Email |
dranashiv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivakumar G |
| Designation |
Professor and HOD |
| Affiliation |
Mandya institute of medical sciences |
| Address |
Department of Anaesthesiology
Mandya institute of medical sciences
Mandya
KARNATAKA
571401
India |
| Phone |
9900468451 |
| Fax |
|
| Email |
dranashiv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia,Mandya institute of medical sciences |
|
|
Primary Sponsor
|
| Name |
Dr Shivakumar G |
| Address |
Professor and HOD
Department of Anaesthesiology
Mandya institute of medical sciences
Mandya |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Archana B N |
Assistant professor
Department of Anaesthesiology
Mandya institute of medical sciences
Mandya |
| Dr Aswin M Ullas |
Post graduate student
Department of Anaesthesiology
Mandya institute of medical sciences
Mandya |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aswin M Ullas |
Mandya institute of medical sciences Mandya |
Department of Anaesthesiology
Mandya
KARNATAKA |
9400864833
aswinmullas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee Mandya institute of medical sciences |
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 |
| Comparator Agent |
Interscalene block |
Blockingsupraclavicular nerve, nerve to subclavius, nerve to suprascapular and long thoracic nerve using bupivacaine 0.5% and lignocaine with adrenaline 1 in 2 lakh. |
| Comparator Agent |
Supraclavicular upper trunk block |
Using bupivacaine 0.5% and lignocaine with adrenaline 1 in 2 lakh Blocking supraclavicular nerve, nerve to subclavius, nerve to suprascapular and long thoracic nerve |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
BMI of 18.5 to 24.9 kg per sq meter
Patients undergoing clavicle surgeries with either SCUT block or interscalene block
ASA PS grades I and II
Patients ready to give informed consent |
|
| ExclusionCriteria |
| Details |
Patients with opioid drug intake for other conditions
Patients on any routine analgesics
Patients who are known diabetics |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome which is measured is maximum time of post operative analgesia after giving block. |
24hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare onset and regression of sensory and motor blockade between the groups after giving block |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/03/2024 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study is to compare supraclavicular upper trunk block and interscalene block as a mode of regional anaesthesia for clavicle surgeries. |