| CTRI Number |
CTRI/2026/03/106052 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effectiveness of two different approaches to block the brachial plexus to provide anesthesia in patients undergoing upperlimb surgeries |
|
Scientific Title of Study
|
Combining Intertruncal Supraclavicular Brachial Plexus Block with Corner Pocket Injection; Is The Technique Superior To Intertruncal Approach Alone – A Randomised 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 |
Udaya Bhaskar K |
| Designation |
Professor |
| Affiliation |
GITAM institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia
GITAM institute of Medical Sciences
Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9980600663 |
| Fax |
|
| Email |
druday79@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Udaya Bhaskar K |
| Designation |
Professor |
| Affiliation |
GITAM institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia
GITAM institute of Medical Sciences
Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9980600663 |
| Fax |
|
| Email |
druday79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Udaya Bhaskar K |
| Designation |
Professor |
| Affiliation |
GITAM institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia
GITAM institute of Medical Sciences
Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9980600663 |
| Fax |
|
| Email |
druday79@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
GIMSR |
| Address |
yendada visakhapatnam |
| 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 |
| Udaya Bhaskar K |
GIMSR |
Operation Theater
3rd floor
Department of Anesthesiology
rushikonda Visakhapatnam
Visakhapatnam
ANDHRA PRADESH |
09980600663
druday79@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional 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 |
intertrucal block combined with cornerpocket injection |
local anaesthetics agent is deposited at the intertruncal planes between the upper and miidle trunks and middle ad lower trunks of the brachial plexus and the corner pocket(junction of subclavian artery, first rib and ulnar nerve). following drug deposition the onset of motor, and sensory block are evaluated at individual distribution sites of the ulnar, radial and median nerve. block is considered as failed if onset of motor or sensory block does not occur within 20 minutes of drug deposition |
| Comparator Agent |
intertruncal block |
local anaesthetic agent is deposited at the intertruncal planes between and upper and middle trunk and middle and lower trunks only. following drug deposition the onset of motor, and sensory block are evaluated at individual distribution sites of the ulnar, radial and median nerve. block is considered as failed if onset of motor or sensory block does not occur within 20 minutes of drug deposition |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients undergoing upper limb surgeries involving the lower arm and forearm |
|
| ExclusionCriteria |
| Details |
patient refusal
infection at site of injuries
coagulation abnormalities
prexisting nerve injuries |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate the block success rate of intertruncal with corner pocket injection over intertruncal in jection alone |
sensory and motor block success is evaluated at every 5minutes after drug deposition upto 20 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of block
post operative VAS scores, requirement of first analgesic dose
adverse events like nerve injuries, pneumothorax, vascular injuries, local anesthetic toxicity |
post operative VAS scores are evaluated every hour after shifting patient to postoperative ward
duration of block is assesed by asking patient the time at which he had recovery of sensory & motor activity at either of ulnar or radial or median nerve distribution sites
adverse events are monitored from the point of performing the block upto recovery of nerve function |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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="0"
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
|
the Intertruncal approach to Brachial plexus block is new technique for administering anesthesia to the upper-limb with minimal nerve injuries, but is still associated with ulnar nerve sparing. so we hypothesized that combining the intertruncal block with corner pocket injection the block success rate can be further increased. a total sample size of sixty was calculated based on previous studies on intertruncal blocks, and those patients coming for upper limb surgeries below the elbow level were randomised either to receieve intertruncal block alone or intertruncal block combined with cornerpocket injection to evaluate the block success rate |