| CTRI Number |
CTRI/2025/02/080076 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ultrasound Guided Interscalene Block in Shoulder and Arm Surgery |
|
Scientific Title of Study
|
A Comparative Evaluation of ultra sound guided In-Plane and Out-of-Plane Interscalene Block Characteristics in Shoulder and Arm Surgery: A Prospective Randomized Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arivazhagan S |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9626825354 |
| Fax |
|
| Email |
shanmugaarivuselvam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Qazi Ehsan Ali |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7417701769 |
| Fax |
|
| Email |
qaziehsanali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arivazhagan S |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9626825354 |
| Fax |
|
| Email |
shanmugaarivuselvam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College Hospital, Aligarh Muslim University, Aligarh
|
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College Hospital |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College Hospital, Aligarh Muslim University, Aligarh
pin-202002 |
| Type of Sponsor |
Government 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 |
| DrArivazhagan S |
Jawaharlal Nehru Medical College and Hospital, AMU |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH |
9626825354
shanmugaarivuselvam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(Regd) Jawaharlal Nehru Medical College and Hospital |
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 |
In-plane Interscalene Block |
In-plane technique of Ultrasound Guided Interscalene Block in Shoulder and Arm Surgery. Duration till successful block |
| Intervention |
Out-of-plane Interscalene Block |
Out-of-plane Interscalene Block in Shoulder and Arm Surgery, duration till successful block. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1 and 2
Weight between 50 and 80 kilograms
Patients undergoing elective shoulder and arm surgery between 2023-2025
|
|
| ExclusionCriteria |
| Details |
Obesity Class 2 and 3
Anticipated difficult airway
Infection at site of injection
Known case of allergy
Contralateral phrenic nerve dysfunction
History of systemic diseases
Neuropathy involving brachial plexus |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The onset of sensory block (time to C5 block) |
Onset of sensory block (time to C5 block) defined the time period between the completion of LA block and the loss of sensation to pin prick (sensory score = 1) in C5 dermatome performed every 1 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The progression of sensory block
The progression of sensory block
Pain score after surgery
The duration of analgesia
Postoperative analgesic requirement
Number of punctures
Ease of visualization
Procedural time
Complications
|
15 min after block |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
17/02/2025 |
| 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="3"
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
|
The thesis titled "Comparative Evaluation of USG-guided In-Plane and Out-of-Plane Interscalene Block Characteristics in Shoulder and Arm Surgery: A Prospective Randomized Study" aims to compare the effectiveness of two ultrasound-guided techniques for administering interscalene brachial plexus blocks in upper limb surgeries. Conducted at Jawaharlal Nehru Medical College, Aligarh Muslim University, this study evaluates the onset, progression, and recovery of sensory and motor blocks, postoperative pain scores, and duration of analgesia in patients undergoing shoulder and arm surgeries. By analyzing in-plane and out-of-plane approaches, the study seeks to determine which method offers better pain relief, faster onset, and fewer complications to improve patient outcomes in regional anesthesia. |