| CTRI Number |
CTRI/2026/01/102502 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Conventional Technique vs Needle Guidance Device in Ultrasound Guided Supraclavicular Block |
|
Scientific Title of Study
|
Comparison of outcome of the conventional approach versus the new needle guidance device to perform ultrasound-guided supraclavicular brachial plexus blockade for forearm surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Muthulakshmi R |
| Designation |
Junior resident |
| Affiliation |
SREE BALAJI MEDICAL COLLEGE and HOSPITAL |
| Address |
Department of Anaesthesiology third floor Sree Balaji medical college and hospital 7 clc works chrompet chennai
Chennai
TAMIL NADU
India
Kancheepuram
TAMIL NADU
600044
India |
| Phone |
9944568213 |
| Fax |
|
| Email |
muthu1312.mm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shanmugapriya |
| Designation |
Assistant Professor |
| Affiliation |
SREE BALAJI MEDICAL COLLEGE and HOSPITAL |
| Address |
Department of Anaesthesiology third floor Sree Balaji medical college and hospital 7 clc works chrompet chennai
Chennai
TAMIL NADU
India
Kancheepuram
TAMIL NADU
600044
India |
| Phone |
9487554371 |
| Fax |
|
| Email |
arsapripre@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shanmugapriya |
| Designation |
Assistant Professor |
| Affiliation |
SREE BALAJI MEDICAL COLLEGE and HOSPITAL |
| Address |
Department of Anaesthesiology third floor Sree Balaji medical college and hospital 7 clc works chrompet chennai
Chennai
TAMIL NADU
India
Kancheepuram
TAMIL NADU
600044
India |
| Phone |
9487554371 |
| Fax |
|
| Email |
arsapripre@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia, third floor.
Sree Balaji Medical college and Hospital. |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology Sree Balaji Medical college and hospital |
| Address |
Sree balaji medical college and hospital 7 Clc works road Shankar nagar Chrompet chennai |
| 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 |
| Muthulakshmi R |
Sree Balaji Medical College and Hospital |
Department of Anesthesiology. Third floor.
7 clc works road. Chrompet.chennai
Kancheepuram
TAMIL NADU |
9944568213
muthu1312.mm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICS COMMITTEE |
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 |
NEEDLE GUIDANCE DEVICE |
The ultrasound and NGD complex is used to scan the nerve to be blocked. When the target nerve is
visualized, the depth of the target nerve and the approach (in plane or out of plane approach ) to
access the nerve is decided. Based on these findings one among the two in-plane needle entry port
would be used depending on the depth of the target nerve to be blocked. Once when the tip of the
needle is close to the target nerve the local anesthetic is injected and spread of the drug around the
nerve is visualized.
The intervention consists of a ultrasound-guided supraclavicular brachial plexus block administered once before surgery. The duration of the intervention is approximately 15–20 minutes per participant. |
| Intervention |
Conventional method |
The probe will be placed lateral to the larynx to visualise the carotid artery and internal jugular vein and
the probe will be moved sideways, the nerve structures in the interscalene groove will become visible.
The probe will then be moved away from the interscalene position to a supraclavicular position. The
subclavian artery will be visualised and will be confirmed by color Doppler. The entire brachial plexus
near the artery will then be visualised. A 23G Quincke needle will be inserted using an in-plane approach.
The local anaesthetic solution will be injected after careful aspiration and will be seen encircling the
trunks. If the local anaesthetic does not spread in the right direction, the needle will be repositioned
accordingly. The intervention consists of ultrasound-guided supraclavicular brachial plexus block administered once before surgery. The duration of the intervention is approximately 15–20 minutes per participant |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted electively for upper limb procedures |
|
| ExclusionCriteria |
| Details |
Patient refusal
Below 18 years and above 65 years
Blood diathesis
Anatomical variation in brachial plexus
Asa 3 and above
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total procedural time for ultrasound-guided supraclavicular brachial plexus block, measured from needle insertion to needle withdrawal, comparing the conventional free-hand technique and the needle guidance device. |
Intra-procedural — measured immediately during block performance from needle-in to needle-out using a stopwatch. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of skin punctures.
Sensory block onset time
Motor block onset time.
Block failure rate requiring supplemental analgesia or conversion to general anaesthesia |
During procedure,number of skin punctures.
Post injection sensory & motor block onset times.
30 minutes after local anaesthetic injection,block success or failure
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
16/02/2026 |
| 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="6"
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
|
Patients who are fulfilling inclusion criteria will be randomly allocated to two groups based on computer generated
randomisation
Group C Conventional method:
The probe will be placed lateral to the larynx to visualise the carotid artery and internal jugular vein and
the probe will be moved sideways, the nerve structures in the interscalene groove will become visible.
The probe will then be moved away from the interscalene position to a supraclavicular position. The
subclavian artery will be visualised and will be confirmed by color Doppler. The entire brachial plexus
near the artery will then be visualised. A 23G Quincke needle will be inserted using an in-plane approach.
The local anaesthetic solution will be injected after careful aspiration and will be seen encircling the
trunks. If the local anaesthetic does not spread in the right direction, the needle will be repositioned
accordingly. Group N
NEEDLE GUIDANCE DEVICE:
The ultrasound and NGD complex is used to scan the nerve to be blocked. When the target nerve is
visualized, the depth of the target nerve and the approach (in plane or out of plane approach ) to
access the nerve is decided. Based on these findings one among the two in-plane needle entry port
would be used depending on the depth of the target nerve to be blocked. Once when the tip of the
needle is close to the target nerve the local anesthetic is injected and spread of the drug around thenerve is visualized. |