| CTRI Number |
CTRI/2026/01/100654 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Two types of Upper arm blocks in patients Undergoing Hand surgeries and one block will be better in reducing pain than the other |
|
Scientific Title of Study
|
Intertruncal Versus Classical Approach to the Ultrasound guided Supraclavicular Brachial Plexus Block for Upper extremity surgeries |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anagha Gopinath P |
| Designation |
Post Graduate |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals, Room number 15, Department of Anaesthesiology
Salem,Tamilnadu
Salem, Tamilnadu 636308
Salem
TAMIL NADU
636308
India |
| Phone |
9497336774 |
| Fax |
|
| Email |
anagha774@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sabapathy Appavoo V A |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Department of Anaesthesiology
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals,Salem,Tamilnadu
Salem, Tamilnadu 636308
Salem
TAMIL NADU
636308
India |
| Phone |
9442566989 |
| Fax |
|
| Email |
sabapathyv.appavoo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sabapathy Appavoo V A |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Department of Anaesthesiology
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals,Salem,Tamilnadu
Salem, Tamilnadu 636308
Salem
TAMIL NADU
636308
India |
| Phone |
9442566989 |
| Fax |
|
| Email |
sabapathyv.appavoo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Kirupananda Variyar Medical College and Hospitals, Salem, Tamilnadu,636308 |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals, Department of Anaesthesiology, Salem, Tamilnadu Tamilnadu 636308 |
| 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 Anagha Gopinath P |
Vinayaka Missions Kirupananda Variyar Medical College and hospitals |
Room no 15
Department of Anaesthesiology Salem, Tamilnadu
Salem
TAMIL NADU |
9497336774
anagha774@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 |
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 |
Classical Approach Supraclavicular Brachial Plexus Block for Upper extremity surgeries |
25 ml of local anaesthetic solution of Inj.Bupivacaine 0.5% is deposited between the first rib and the inferolateral surface of sternocleidomastoid muscle done within 15 minutes |
| Intervention |
Intertruncal ultrasound guided Supraclavicular Brachial Plexus Block for upper extremity surgeries |
1) 12.5 ml of local anaesthetic solution of Inj.Bupivacaine 0.5% is deposited between upper and middle trunk and 12.5 ml of same solution between the middle and lower trunks of Brachial plexus in patients undergoing upper extremity surgeries (total 25 ml of 0.5% Inj.Bupivacaine) done within 15 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18 years to 60 years
ASA Grade 1 and 2
Patients giving valid informed consent
Elective upper extremity surgeries |
|
| ExclusionCriteria |
| Details |
Age less than 18 years and more than 60 years
ASa grade 3 and 4
Patient refusal
Patients with local infection at the puncturing site, allergic to local anaesthetic drugs
Patients posted for emergency surgeries |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients with a complete ulnar nerve blockade was significantly higher with the intertruncal approach compared to the classical approach to the Ultrasound guided Supraclavicular Brachial Plexus Block for Upper extremity surgeries |
From the time of giving block to 2 hours post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Intertruncal approach can be an alternative for a better outcome of Supraclavicular Brachial Plexus Block regarding the ulnar nerve blockade |
From the time of giving block to 2 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
24/01/2026 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This is a prospective randomised single blinded clinical comparitive study to compare the efficacy of Intertruncal versus Classical approach in terms of ulnar nerve blockade to the ultrasound guided Supraclavicular Brachial Plexus Block for upper extremity surgeries. |