| CTRI Number |
CTRI/2026/04/108614 [Registered on: 17/04/2026] Trial Registered Prospectively |
| Last Modified On: |
17/04/2026 |
| 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
|
Comparison Of Two Pain Relief Techniques Before Nerve Block In The Neck |
|
Scientific Title of Study
|
Efficacy Of Superficial Cervical Plexus Block versus Local Infiltration As A Mode Of Analgesia Before Brachial Plexus Block Procedure In The Neck A Prospective Randomized Control 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 ASIF MOHAMED P |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
DR VIJAY NARAYANAN S |
| Address |
Department Of Anaesthesia First Floor Chettinad Hospital And Research Institute Rajiv Gandhi Salai Kelambakkam Kancheepuram
Department Of Anaesthesia First Floor Chettinad Hospital And Research Institute Rajiv Gandhi Salai Kelambakkam Kancheepuram
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
8760361406 |
| Fax |
|
| Email |
Mohamedasif419@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ASIF MOHAMED P |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
DR VIJAY NARAYANAN S |
| Address |
Department Of Anaesthesia First Floor Chettinad Hospital And Research Institute Rajiv Gandhi Salai Kelambakkam Kancheepuram
Department Of Anaesthesia First Floor Chettinad Hospital And Research Institute Rajiv Gandhi Salai Kelambakkam Kancheepuram
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
8760361406 |
| Fax |
|
| Email |
Mohamedasif419@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ASIF MOHAMED P |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
DR VIJAY NARAYANAN S |
| Address |
Department Of Anaesthesia First Floor Chettinad Hospital And Research Institute Rajiv Gandhi Salai Kelambakkam Kancheepuram
Department of Anaesthesia First Floor
Chettinad Hospital And Research Institute Rajiv Gandhi salai Kelambakkam Kancheepuram
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
8760361406 |
| Fax |
|
| Email |
Mohamedasif419@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Chettinad Hospital And Research Institute |
| Address |
Department of Anaesthesia First Floor Chettinad Hospital And Research Institute Rajiv Gandhi Salai Kelambakkam Kancheepuram 603103
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 ASIF MOHAMED P |
CHETTINAD HOSPITAL AND RESEARCH INSTITUTE |
DEPARTMENT OF ANAESTHESIA
1ST FLOOR
CHETTINAD HOSPITAL AND RESEARCH INSTITUTE
RAJIV GANDHI SALAI
KELAMBAKKAM
KANCHEEPURAM
TAMILNADU
603103
Kancheepuram
TAMIL NADU |
8760361406
Mohamedasif419@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICS COMMITTEE FOR STUDENT RESEARCH |
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 |
Local Infiltration |
Local Infiltration For Analgesia Before Brachial Plexus Block |
| Intervention |
Superficial Cervical Plexus Block |
Superficial Cervical Plexus Block For Analgesia Before Brachial Plexus Block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA Physical Status I or II
Patients With Age 18 to 65 Years
Patients Posted For Upper Limb Surgeries |
|
| ExclusionCriteria |
| Details |
Refusal To Participate
Allergy To Local Anesthetics
Coagulopathy Or Bleeding Disorders
Infection At The Injection Site
Pre Existing Neurological Deficits In The Upper Limbs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare Verbal pain rating scale during the BPB procedure between the Superficial cervical plexus block and local infiltration groups. |
Baseline pre procedure
During procedure
Before Brachial plexus block
After 5mins of procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate patient satisfaction with five point likert scale.
To study hemodynamic changes |
Baseline Pre procedure
During procedure
Before Brachial plexus block
After 5mins of procedure |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
29/04/2026 |
| 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 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
|
This prospective randomized controlled study aims to evaluate the efficacy of superficial cervical plexus block compared to local infiltration as a method of analgesia prior to performing brachial plexus block procedures in the neck The study will assess parameters including pain during needle insertion patient comfort ease of block performance and any procedure related complications Participants will be randomly allocated into two groups one receiving superficial cervical plexus block and the other receiving local anesthetic infiltration at the puncture site Outcomes will be measured using validated pain scores and procedural metrics The findings are expected to identify a superior analgesic technique that improves patient comfort and procedural success during brachial plexus block |