| CTRI Number |
CTRI/2025/01/079832 [Registered on: 31/01/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of
ultrasound guided costoclavicular and axillary brachial plexus block for upper limb surgery: |
|
Scientific Title of Study
|
Comparison of
ultrasound guided costoclavicular and axillary brachial plexus block for upper limb surgery:
A prospective randomized 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 |
VIGNESH S |
| Designation |
Post Graduate Student |
| Affiliation |
BJ Medical College Ahmedabad |
| Address |
Department of Anaesthesiology Room No B-504
Phase 2
BJ Medical College & Hospital
Asarwa
Ahemdabad
Gujarat
India
Pin -380016
380016
Ahmadabad
GUJARAT
380016
India |
| Phone |
9994776270 |
| Fax |
|
| Email |
vigneshboss27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Siddharthkumar B parmar |
| Designation |
Associate Professor (HG) |
| Affiliation |
BJ Medical College Ahmedabad |
| Address |
Department of Anaesthesiology
BJ Medical College
Civil Hospital
Asarwa
Ahmedabad -380016
Ahmadabad
GUJARAT
380016
India |
| Phone |
9426332701 |
| Fax |
|
| Email |
drsid25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Siddharthkumar B parmar |
| Designation |
Associate Professor (HG) |
| Affiliation |
BJ Medical College Ahmedabad |
| Address |
Department of Anaesthesiology
BJ Medical College
Civil Hospital
Asarwa
Ahmedabad -380016
Ahmadabad
GUJARAT
380016
India |
| Phone |
9426332701 |
| Fax |
|
| Email |
drsid25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,
BJ Medical college and
Civil Hospital,
Asarwa ,
Ahemdabad ,
Gujarat,
India.
Pin -380016 |
|
|
Primary Sponsor
|
| Name |
VIGNESH S |
| Address |
Department of Anaesthesiology
Room No B-504,
Phase 2 ,
BJ Medical College and
Civil Hospital ,
Asarwa ,
Ahemdabad,
Gujarat ,
India.
Pin-380026 |
| Type of Sponsor |
Other [Self] |
|
|
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 VIGNESH S |
Civil Hospital,Asarwa ,Ahemdabad ,Gujarat ,India,Pin-380016 |
Department of Anaesthesiology
Room No -F 3 1st Floor
BJ Medical College
Asarwa
Ahmedabad
Gujarat
India
Pin-380016
Ahmadabad
GUJARAT |
9994776270
vigneshboss27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee, BJ Medical College and Civil Hospital, Ahemdabad |
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 |
Ultrasound guided Axillary Brachial plexus block. |
The onset time of sensory and motor block of Radial, Ulnar, Median and
Musculocutaneous Nerve
Duration - onset upto 30min. For postop analgesia study will end after 12hrs of
post-op
Study will end after 12hrs of post-op.
Dose-Inj. Bupivacaine 0.5%(20ml) + Inj. Lignoadrenaline 2%(10ml). Total -30ml.
Route of approach - Drug injected between the cords by Stimuplex needle and Ultrasound guided |
| Intervention |
Ultrasound guided Costoclavicular Brachial plexus block |
The onset time of sensory and motor block of Radial,Ulnar, Median and
Musculocutaneous Nerve.
Duration -Onset upto 30min.
For post op Analgesia Study will end after 12 hours of post-op
Dose-Inj.Bupivacaine 0.5%(20ml) + Inj.Lignoadrenaline 2%(10ml).Total -30ml.
Route of approach -Drug injected between the cords by Stimuplex needle and Ultrasound guided |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I, II and III
Patients scheduled for Forearm and wrist surgeries
Elective surgeries
Patient willing to give informed consent for the study |
|
| ExclusionCriteria |
| Details |
ASA IV and V
Patients refusing to give Informed consent.
Patients having pre-existing cardiac, neurological and respiratory diseases.
Local infection/ inflammation.
Patients having coagulopathy and patient on anticoagulants
Contralateral lung injury and rib fracture.
Pre-existing neuropathy involving the surgical limb.
History of allergy to local anesthetic drug
Pregnant women.
Failure of Regional blocks |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
onset time of sensory and motor block of Radial, Ulnar, Median and
Musculocutaneous Nerve to the scale of 0-2 score till block achieved |
Every 5 minute after block performance for 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare Performance time
To compare Ultrasound scanning time
To study the Success rate
To compare Duration of analgesia
To Study and evaluate Complications like haematoma,etc |
All the above parameters will be observed at 5 minutes interval for 30 minutes. |
|
|
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)
|
13/02/2026 |
| 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="1"
Months="0"
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
|
Costoclavicular approach is one of the medial approach of infraclavicular block, performed in the costoclavicular space. It will block three cords around the axillary artery. This space located anteriorly between subclavius muscle and pectoralis major (Clavicular head), posteriorly serratus anterior muscle (upper slips) and second rib. In this space, Cords are clustered and appeared more superficially compared to classical approach. [4] Axillary nerve block is most used for hand, elbow and forearm surgeries due to low complications. In axillary block approach by USG, Median nerve, Ulnar nerve, Radial nerve and Musculocutaneous nerve are targeted. We undertook this study as CCB is emerging infraclavicular block and there is less study available which compares the CCB with Axillary block |