| CTRI Number |
CTRI/2025/03/082256 [Registered on: 13/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of Two Approaches for Anesthesia of Upper Limb Surgeries |
|
Scientific Title of Study
|
Comparison of Ultrasound guided Supraclavicular versus Infraclavicular Block in patients undergoing Upper Limb 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 |
Abhi Ladani |
| Designation |
PG Student |
| Affiliation |
GCS Medical College, Hospital and Research Centre |
| Address |
Department of Anesthesia, GCS Medical College Hospital and Research Centre
Ahmadabad
GUJARAT
380025
India |
| Phone |
8200382798 |
| Fax |
|
| Email |
ladaniabhi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ASMITA CHAUDHARY |
| Designation |
PROFESSOR |
| Affiliation |
GCS Medical College, Hospital and Research Centre |
| Address |
Department of Anesthesia, GCS Medical College Hospital and Research Centre
Ahmadabad
GUJARAT
380025
India |
| Phone |
9879006601 |
| Fax |
|
| Email |
asmivip@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Abhi Ladani |
| Designation |
PG Student |
| Affiliation |
GCS Medical College, Hospital and Research Centre |
| Address |
Department of Anesthesia, GCS Medical College Hospital and Research Centre
Ahmadabad
GUJARAT
380025
India |
| Phone |
8200382798 |
| Fax |
|
| Email |
ladaniabhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| GCS Medical College, Hospital and Research Centre, Near Chamunda Bridge, Saraspur, Ahmedabad, Gujarat, India-380025 |
|
|
Primary Sponsor
|
| Name |
GCS MEDICAL COLLEGEHOSPITAL AND RESEARCH CENTRE |
| Address |
GCS Medical College, Hospital and Research Centre, Near Chamunda Bridge, Saraspur, Ahmedabad, Gujarat, India - 380025 |
| 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 Abhi Ladani |
GUJARAT CANCER SOCIETY HOSPITAL |
Room No 105, Department of Anesthesia, GCS Hospital, SARASPUR, AHMEDABAD- 380025
Ahmadabad
GUJARAT |
8200382798
ladaniabhi@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 |
| Comparator Agent |
Infraclavicular Brachial Plexus Block |
Patients are induced for Operative Procedure under Infraclavicular Brachial Plexus Block with Inj 0.25% Bupivacaine Hydrochloride 20ml perineural and various parameters are observed for 6 hours |
| Intervention |
Supraclavicular Brachial plexus Block |
Patients are induced for Operative Procedure under Supraclavicular Brachial Plexus Block with Inj 0.25% Bupivacaine Hydrochloride 20ml perineural and various parameters are observed for 6 hours |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA Grade 1 to 3
2. Elective Surgeries of Forearm and Hand |
|
| ExclusionCriteria |
| Details |
1. ASA Grade 4
2. Pregnant Women |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hemodynamics (Pulse rate, Systolic BP, Diastolic BP, SpO2) |
15 mins
30 mins
60 mins
120 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total Duration of Analgesia after Induction of Anesthesia & post operatively |
0 min
2 hours
6 hurs
12 hours |
|
|
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)
|
01/04/2025 |
| 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="2"
Months="6"
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
|
Ultrasound Guided Brachial Plexus Blocks are the mainstay in the Anesthesia for Upper Limb Surgeries.
Our Study Aims at comparing two different approaches to Brachial Plexus Blocks in regard to various observation parameters such as Block Performance Time, Onset of Sensory Block, Onset of Motor Block, Duration of Sensory Block, Duration of Motor Block, Total Duration of Analgesia, Incidence of Various Complications, Patient Comfort Level and overall success rate of Block |