| CTRI Number |
CTRI/2024/08/073150 [Registered on: 30/08/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
post operative pain management of two different approach , intertruncal and corner pocket approach for supraclavicular block of ulnar nerve |
|
Scientific Title of Study
|
Effect Of Intertruncal And Corner-Pocket Approach Of Ultrasound Guided Supraclavicular Block In Terms Of Ulnar Nerve Blockade: A Randomised Control Trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Stephen |
| Designation |
post graduate |
| Affiliation |
sri venkateshwaraa medical college hospital and research centre,ariyur,puducherry |
| Address |
Department of anesthesiology and critical care.sri venkateshwaraa medical college hospital and research centre No 13-A ,pondy - villupuram main road,ariyur,pondicherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9092059240 |
| Fax |
|
| Email |
stephenjesu44@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Radhakrishnan |
| Designation |
PROFESSOR |
| Affiliation |
Department of anesthesia,sri venkateswaraa medical college hospital and research centre,puducherry |
| Address |
Room No-13-A,Pondy-Villupuram Main Road,Ariyur,Pondicherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8825778958 |
| Fax |
|
| Email |
rkpuduvai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Stephen |
| Designation |
post graduate |
| Affiliation |
sri venkateshwaraa medical college hospital and research centre,ariyur,puducherry |
| Address |
Department of anesthesiology and critical care.sri venkateshwaraa medical college hospital and research centre No 13-A ,pondy - villupuram main road,ariyur,pondicherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9092059240 |
| Fax |
|
| Email |
stephenjesu44@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri venkateswaraa medical college hospital and research center, No 13-A pondy-villupuram main
road,Ariyur, Puducherry, India 605102 |
|
|
Primary Sponsor
|
| Name |
Dr Stephen |
| Address |
Room No 13-A, Department Of Anaesthesiology,Ot Complex,Srivenkateswaraa Medical College Hospital And Research Center,Pondicherry-605107,India |
| 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 Stephen |
Sri Venkateshwaraa medical college, hospital and research centre |
Department of anesthesia,Room no 13-a,pondy-villupuram main road,ariyur
Pondicherry
PONDICHERRY |
9092059240
stephenjesu44@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Human Studies) |
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 |
SUPRACLAVICULAR BLOCK |
Group A will receive 10 ml of 2% lignocaine with adrenaline and 15ml 0.375% of ropiva- caine through intertruncal approach
|
| Comparator Agent |
SUPRACLAVICULAR BLOCK |
Group B will receive 10 ml of 2% lignocaine with adrenaline and 15ml 0.375% of ropiva- caine through corner-pocket approach |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
american society of anesthesiologist grade 1 and 2 patients of either sex from 18-65 years of age undergoing upper limb surgeries will be included in the study |
|
| ExclusionCriteria |
| Details |
History of allergy to local anesthetics ,Coagulation disorder ,Mental health issues
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the complete sensory blockade of the ulnar nerve in intertruncal and corner-pocket approach |
15mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the complete sensory blockade and motor blockade of radial ,median and musculocutaneous nerves in intertruncal and corner-pocket approach |
5mins,10mins,15mins,30mins,45mins,60mins,75mins,90mins,105mins,120mins |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
09/09/2024 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [stephenjesu44@gmail.com].
- For how long will this data be available start date provided 09-09-2024 and end date provided 09-03-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This thesis investigates the comparative effectiveness of two ultrasound-guided techniques—intertruncal and corner-pocket approaches—for supraclavicular block in terms of ulnar nerve blockade. Conducted as a randomized controlled trial, the study aims to determine which technique provides superior outcomes for ulnar nerve blockade, a critical factor for achieving optimal analgesia in upper limb surgeries. By evaluating parameters such as the success rate, onset time, and duration of ulnar nerve blockade, the research seeks to provide evidence-based recommendations for improving the efficacy of supraclavicular blocks. |