| CTRI Number |
CTRI/2025/06/088054 [Registered on: 02/06/2025] Trial Registered Prospectively |
| Last Modified On: |
31/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparative study of ultrasound guided infraclavicular block versus retroclavicular block with 0.5 percent levobupivacaine |
|
Scientific Title of Study
|
Comparison between Ultrasound guided infraclavicular block versus retroclavicular block with 0.5 percent levobupivacaine |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mukesh Kumar |
| Designation |
Junior Resident |
| Affiliation |
GSVM Medical College kanpur |
| Address |
Department of Anaesthesia and critical care gsvm medical College kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9759101491 |
| Fax |
|
| Email |
mk337189@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandrashekhar Singh |
| Designation |
Professor |
| Affiliation |
GSVM Medical College kanpur |
| Address |
Department of Anaesthesia and critical care and pain medicine gsvm medical College kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9759101491 |
| Fax |
|
| Email |
chandrashekhar77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandrashekhar Singh |
| Designation |
Professor |
| Affiliation |
GSVM Medical College kanpur |
| Address |
Department of Anaesthesia and critical care and pain medicine gsvm medical College kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9759101491 |
| Fax |
|
| Email |
chandrashekhar77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and critical care and pain medicine gsvm medical College kanpur uttar pradesh 208002 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia and critical care and pain medicine |
| Address |
Department of Anaesthesia and critical care and pain medicine gsvm medical College kanpur uttar pradesh 208002 |
| 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 |
| Dr C S singh |
Gsvm Medical college |
Department of Anaesthesia and critical care and pain medicine gsvm medical College kanpur
Kanpur Nagar
UTTAR PRADESH |
9236072730
chandrashekhar77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee gsvm Medical College kanpur |
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 |
Infraclavicular block, retroclavicular block |
Ultrasound guided infraclavicular block versus retroclavicular block using 0.5% levobupivacaine in orthopedic surgery of upper limb |
| Comparator Agent |
Infraclavicular block,retroclavicular block |
Comparison of two technique infraclavicular block and retroclavicular block under ultrasound guidance 15 ml levobupivacaine 0.5% in orthopedic surgery of upper limb using stemoplex needle |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to participate in study.
Patients above the age of 18 years having the concerned disease.
Elective surgery of the hand, wrist, forearm or elbow.
Able to provide valid written consent. |
|
| ExclusionCriteria |
| Details |
Patients refusal
Systemic or local infection at the needle entry point
Coagulopathy
Severe pulmonary condition
Local anaesthetic allergy
Pregnancy
Preexisting neurologic symptoms in the ipsilateral limb |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Extent and duration of motor and sensory block.
Intraoperative and postoperative pain, assessment using VAS SCORE.
Extent of block and duration of block assessed using dermatomal distribution at 30 min, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours postoperatively. |
5 min,10 min, 15 min, 20 min, 25 min,30 min, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Needle visibility
Block success rate
Number of attempts to achieved full effect.
Block performance time
Procedure related pain, complications and patients and surgeon satisfaction. |
5 min,10 min, 15 min, 20 min, 25 min,30 min, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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 |
|
Date of First Enrollment (India)
|
13/06/2025 |
| 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="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
|
Our general objective is to make a formal comparison between RCB[10, 11] and coracoid ICB for brachial plexus anaesthesia. This study will delineate the differences between the two techniques. Our aim is to compare both techniques in terms of scanning time, needling time, total anaesthesia time, needle visibility, block needle passes, block success and early and late complications. We made the hypothesis that, while providing similar efficacy and better needle visualization than coracoid ICB, the time taken to perform RCB will not exceed the time taken to perform its comparator.
|