| CTRI Number |
CTRI/2025/04/083997 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
02/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two technique in supraclavicular brachial plexus block |
|
Scientific Title of Study
|
A Comparison of inter truncal versus corner pocket technique of ultrasound guided supraclavicular approach for brachial plexus block |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjay Choubey |
| Designation |
Professor |
| Affiliation |
Era medical college |
| Address |
Department of anesthesiology,
Era medical college
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8840155309 |
| Fax |
|
| Email |
sanjay.choubey@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajesh kumar |
| Designation |
Assistant professor |
| Affiliation |
Era medical college |
| Address |
Department of anesthesiology
Era medical college,
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8299081739 |
| Fax |
|
| Email |
docraj198810@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Richa tripathi |
| Designation |
Junior resident |
| Affiliation |
Era medical college |
| Address |
Department of anesthesiology,
Era medical college
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7985374745 |
| Fax |
|
| Email |
richatripathi1963@gmail.com |
|
|
Source of Monetary or Material Support
|
| Era medical college & Hospital, Tondan Marg,Sarfarazganj,Lucknow,
Uttar Pradesh 226003 |
|
|
Primary Sponsor
|
| Name |
Era medical college |
| Address |
Department of anaesthesia
Era medical college & Hospital, Tondan Marg,Sarfarazganj,Lucknow, Uttar Pradesh 226003
lucknow,up |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| richa tripathi |
department of anaesthesia
era medical college
lucknow,up |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Richa tripathi |
Era medical college & Hospital |
Department of anesthesiology
3rd floor, Operation theatre complex
Lucknow
UTTAR PRADESH |
07985374745
richatripathi1963@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Eras Lucknow Medical College & Hospital , Era University , Lucknow |
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 |
inj levobupivacaine 0.5%
|
30 ml of LA (150 mg), frequency- once , duration of procedure-10 mins , route- regional nerve root block , TO check the onset of sensory and motor block |
| Intervention |
supraclavicular brachial plexus block |
Comparison of inter truncal versus corner pocket technique of ultrasound guided supraclavicular approach for brachial plexus block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age group 18-60 years
Gender (Male/Female)
ASA physical status I and II
Patients undergoing elective surgery for
upper limb
|
|
| ExclusionCriteria |
| Details |
Patients with shoulder surgery
Pre-existing neuropathy
Bleeding diathesis
Hypersensivity to local anaesthetic
Pregnancy
Obesity
Lactating mothers
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the Block characteristics of the two approaches Inter-truncal versus Corner pocket technique of SCB . |
At 5min,10min,15min,20min,25min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To compare block performance time
2)To compare Pain score (VAS).
3)To compare duration of post – operative analgesia
4)To study adverse effects & complications of the two approaches
|
1 hour,2 hour ,3 hour ,4 hour ,5 hour ,6 hour |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
16/04/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [richatripathi1963@gmail.com].
- For how long will this data be available start date provided 26-08-2024 and end date provided 26-01-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
in this study we are comparing two approach to give block in supraclavicular plexus in upper limb surgery and see which approach is better and safe in surgery |