| CTRI Number |
CTRI/2026/01/102194 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
25/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [BLOCK] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARING THE EFFICACY OF TWO REGIONAL ANESTHETIC BLOCKS IN SHOULDER AND PROXIMAL HUMERUS SURGERIES |
|
Scientific Title of Study
|
A STUDY TO COMPARE THE EFFICACY OF ULTRASOUND GUIDED INTERSCALENE BLOCK VERSUS SUPERIOR TRUNK BLOCK IN SHOULDER AND PROXIMAL HUMERUS 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 |
Dr Khevna Andharia |
| Designation |
First Year PG student, Department of Anaesthesia |
| Affiliation |
GCS Medical College, Hospital & Research Centre |
| Address |
B block Hostel
Gujarat Cancer Society Medical College Hospital & Research Centre
Near Chamunda Bridge
Naroda
Ahmedabad
Gujarat
Ahmadabad
GUJARAT
380025
India |
| Phone |
9426375727 |
| Fax |
|
| Email |
khevnah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bipin Shah |
| Designation |
Proffesor and Head of Department, Department of Anaesthesia |
| Affiliation |
GCS Medical College, Hospital & Research Centre |
| Address |
Department of Anaesthesia
Gujarat Cancer Society Medical College Hospital & Research Centre
Near Chamunda Bridge
Naroda
Ahmedabad
Gujarat
Ahmadabad
GUJARAT
380025
India |
| Phone |
9824260192 |
| Fax |
|
| Email |
bipinkant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bipin Shah |
| Designation |
Proffesor and Head of Department, Department of Anaesthesia |
| Affiliation |
GCS Medical College, Hospital & Research Centre |
| Address |
Department of Anaesthesia
Gujarat Cancer Society Medical College Hospital & Research Centre
Near Chamunda Bridge
Naroda
Ahmedabad
Gujarat
Ahmadabad
GUJARAT
380025
India |
| Phone |
9824260192 |
| Fax |
|
| Email |
bipinkant@gmail.com |
|
|
Source of Monetary or Material Support
|
| GCS hospital, Near Chamunda Bridge,Saraspur, Ahmedabad, Gujarat- 380025
India |
|
|
Primary Sponsor
|
| Name |
GCS Hospital |
| Address |
GCS Medical College, hospital and research center opp DRM offoce near Chamunda Bridge Ahmedabad |
| 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 Bipin Shah |
Gujarat Cancer Society Medical College Hospital and Research Center |
Room NO 105
Anaesthesia OPD
Department of Anaesthesia
Gujarat Cancer Society Medical College Hospital and Research Center
Ahmedabad
Ahmadabad
GUJARAT |
9824260192
bipinkant@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: S422||Fracture of upper end of humerus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
SUPERIOR TRUNK BLOCK AND INTERSCALENE BLOCK |
COMPARING THE ULTRASOUND GUIDED BLOCKS TO ASSESS THEIR EFFICACY IN TERMS OF DIAOHRAGMATIC PARALYSIS IN SHOULDER AND PROXIMAL HUMERUS SURGERIES |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 2 and 3 |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| NO HEMIDIAPHRAGMATIC PARALYSIS WITH SUPERIOR TRUNK BLOCK |
PRIOR TO BLOCK
AFTER BLOCK
AFTER SURGERY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| HEMODYNAMICS |
PRIOR TO BLOCK
1 MIN AFTER BLOCK
5 MINS AFTER BLOCK
10 MINS AFTER BLOCK
15 MINS AFTER BLOCK
30 MINS AFTER BLOCK
2 HRS AFTER BLOCK
3 HRS AFTER BLOCK |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
10/02/2026 |
| 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="2"
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 study aims to evaluate and compare the clinical efficacy of two regional anesthesia techniques—ultrasound-guided interscalene block (ISB) and superior trunk block (STB)—in patients undergoing shoulder and proximal humerus surgeries. Both blocks are commonly used to provide perioperative analgesia in upper limb surgeries, but differ in anatomical target, potential complications, and spread of anesthesia. |