| CTRI Number |
CTRI/2025/07/092014 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clavicular Bone Surgeries with Superficial Cervical Plexus and Clavipectoral Fascial Plane Regional Anaesthesia Blocks alone |
|
Scientific Title of Study
|
Combination of USG guided Superficial Cervical Plexus Block and Clavipectoral Fascial Plane Block as sole anaesthetic for Clavicular surgeries-A Prospective Observational Study |
| 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 R Brindha |
| Designation |
Professor and Head of Department |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
| Address |
Room number 15 Department of Anaesthesia
Salem
TAMIL NADU
636308
India |
| Phone |
9443247021 |
| Fax |
|
| Email |
mskbrins63@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Naveena |
| Designation |
Associate Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
| Address |
Room number 15 Department of Anaesthesia
Salem
TAMIL NADU
636308
India |
| Phone |
9486198407 |
| Fax |
|
| Email |
naveenasen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Mohamed Asiq |
| Designation |
Post Graduate Resident |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
| Address |
Room number 15 Department of Anaesthesia
Salem
TAMIL NADU
636308
India |
| Phone |
9940051899 |
| Fax |
|
| Email |
m.mohamedasiq@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Mission Kirubanandha Variyar Medical College And Hospital Salem |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
| Address |
Chinna Seeragapadi, Salem – 636 308, Tamil Nadu, India |
| 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 |
| Dr M Mohamed Asiq |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
Room number 15 Department of Anaesthesia
Salem
TAMIL NADU |
9940051899
m.mohamedasiq@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Salem |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Superficial Cervical Plexus and Clavipectoral Fascial Plane Block |
Combination of USG guided Superficial Cervical Plexus Block and Clavipectoral Fascial Plane Block as sole anaesthetic for Clavicular surgeries using 0.75 % Ropivacaine and 0.5 % Levobupivacaine |
| Intervention |
Superficial Cervical Plexus and Clavipectoral Fascial Plane Block |
Combination of USG guided Superficial Cervical Plexus Block and Clavipectoral Fascial Plane Block as sole anaesthetic for Clavicular surgeries using 0.75 % Ropivacaine and 0.5 % Levobupivacaine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1 and 2
Age between 18 - 60 years (Both Males and Females)
Elective and Emergency Clavicular Surgeries with no other Injuries
Patient Acceptance |
|
| ExclusionCriteria |
| Details |
Patient refusal
ASA grade 3 and 4
Patients on anti coagulants
Infection at puncture site
Allergic to local anaesthetic
Patient already a known case of epilepsy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of the block for surgical anaesthesia intraoperatively and for post operative analgesia for clavicular surgeries |
From 0 minutes of administering the block upto patient started developing pain |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the complications associated with this block like hypotension,bradycardia,LAST and motor blockade of upper limb |
From 0 minutes of administering the block upto patient getting discharged |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/06/2026 |
| 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 Yet Recruiting |
| 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
|
Combination of USG guided Superficial Cervical Plexus Block and Clavipectoral Fascial Plane Block as sole anaesthetic for Clavicular surgeries will detremine the efficacy of Block for Surgical anaethesia Intraoperatively and Post Operative Analgesia along with any complications associatd with it if any |