| CTRI Number |
CTRI/2025/02/081192 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A study comparing effectiveness of brachial plexus block using supraclavicular approach by Peripheral Nerve Stimulator and ultrasound guided in upper limb surgeries |
|
Scientific Title of Study
|
Comparative study of efficacy between Peripheral Nerve Stimulator versus Ultrasound guided supraclavicular brachial plexus block in 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 |
Dr Raushan Kumar Chaudhary |
| Designation |
Post Graduate Trainee |
| Affiliation |
Bankura Sammilani Medical College and Hospital |
| Address |
Department of Anaesthesiology, Bankura Sammilani Medical College and Hospital, Lokepur, Post office- Kenduadihi, Bankura. PIN- 722102,West Bengal, India
Bankura
WEST BENGAL
722102
India |
| Phone |
8448834537 |
| Fax |
|
| Email |
chaudharyraushan4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swarup Dutta |
| Designation |
Associate professor |
| Affiliation |
Bankura Sammilani Medical College and Hospital |
| Address |
Department of Anaesthesiology, Bankura Sammilani Medical College and Hospital, Lokepur, Post office- Kenduadihi, Bankura. PIN- 722102,West Bengal, India
Bankura
WEST BENGAL
722102
India |
| Phone |
9433508304 |
| Fax |
|
| Email |
drsdatta66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soumen Saha |
| Designation |
Assistant professor |
| Affiliation |
Bankura Sammilani Medical College and Hospital |
| Address |
Department of Anaesthesiology, Bankura Sammilani Medical College and Hospital, Lokepur, Post office- Kenduadihi, Bankura. PIN- 722102,West Bengal, India
Bankura
WEST BENGAL
722102
India |
| Phone |
9733673040 |
| Fax |
|
| Email |
soumenpg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Office to principal, Department of Anaesthesiology, Bankura Sammilani Medical College and Hospital, Lokepur, Post office- Kenduadihi, Bankura. PIN- 722102,West Bengal, India |
|
|
Primary Sponsor
|
| Name |
Bankura Sammilani Medical College |
| Address |
Department of Anaesthesiology, Bankura Sammilani Medical College and Hospital, Lokepur, Post office- Kenduadihi, Bankura. PIN- 722102,West Bengal, India |
| 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 Raushan Kumar chaudhary |
Bankura sammilani medical College |
Department of Anaesthesiology, Lokepur, Post office- Kenduadihi, Bankura. PIN- 722102,West Bengal, India
Bankura
WEST BENGAL |
8448834537
chaudharyraushan4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee of Bankura sammilani medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S499||Unspecified injury of shoulder andupper arm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Supraclavicular brachial plexus block via PNS |
PNS Guided Brachial Plexus Block by Supraclavicular approach with Bupivacaine (0.5 %) and Lignocaine (2 %) |
| Intervention |
Supraclavicular brachial plexus block via Ultrasound guidance |
Ultrasound guided Brachial Plexus Block by Supraclavicular approach with Bupivacaine (0.5 %) and Lignocaine (2 %) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to give consent to the above study
Patients of age group 18-60 years males and females,
ASA physical grading I and II,
Posted for Elective surgery involving upper limbs, |
|
| ExclusionCriteria |
| Details |
Patients refusal for procedure.
Patients with Neurological deficit,
Infection at the site of block and Peripheral neuropathy.
Patients with pre-existing significant systemic diseases.
Patients with History of psychiatric illness.
Patients with history of allergy to amide group of local anaesthetics.
Patients with significant coagulopathies |
|
|
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 |
The primary aim of the study will be to compare efficacy between the both Techniques of the supraclavicular approach of brachial plexus block in terms of-
Time taken for block
Time of onset
Quality of sensory and motor blockade
Duration of analgesia
Failure rate |
3 MINUTES TO 2 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ultrasound guided supra clavicular brachial plexus block will have better block characteristics than peripheral nerve stimulator in Upper limb surgeries.
Ultrasound guided supra clavicular brachial plexus blocks will have more block duration than peripheral nerve stimulator in Upper limb surgeries .
Ultrasound guided supra clavicular brachial plexus block will have minimal complications like pneumothorax etc |
2-4 hours |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
04/03/2025 |
| 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="3"
Days="7" |
|
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
|
COMPARATIVE STUDY OF EFFICACY BETWEEN PERIPHERAL NERVE STIMULATOR VERSUS ULTRASOUND GUIDED SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK IN UPPER LIMB SURGERIES PRIMARY OBJECTIVE: The primary aim of the study will be to compare efficacy between the both Techniques of the supraclavicular approach of brachial plexus block in terms : Time taken for block Time of onset Quality of sensory and motor blockade Duration of analgesia Failure rate SECONDARY OBJECTIVE: Occurrence of complications such as : Nausea Vomiting Hypotension Arrhythmias Convulsion |