| CTRI Number |
CTRI/2025/11/098063 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
25/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A prospective randomized comparative study of Ultrasound- guided and Landmark- based supraclavicular brachial plexus block techniques for upper limb surgeries in a tertiary care hospital. |
|
Scientific Title of Study
|
A Comparative study of Ultrasound- guided versus Landmark- based supraclavicular brachial plexus block techniques in upper limb surgeries at Tertiary Care Setting. |
| 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 Kamei |
| Designation |
Post Graduate Trainee |
| Affiliation |
Regional Institute of Medical Sciences, Imphal |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal
Imphal West Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
9612989964 |
| Fax |
|
| Email |
stephen33kamei@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
N Anita Devi |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences, Imphal |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal
Imphal West Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
7005346580 |
| Fax |
|
| Email |
dranitadevin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
N Anita Devi |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences, Imphal |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal
Imphal West Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
7005346580 |
| Fax |
|
| Email |
dranitadevin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology Regional Institute of Medical Sciences Imphal
Imphal West Manipur 795004 |
|
|
Primary Sponsor
|
| Name |
Stephen Kamei |
| Address |
Regional Institute of Medical Sciences Imphal
Imphal West Manipur 795004 |
| Type of Sponsor |
Other [Post Graduate Trainee] |
|
|
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 Kamei |
Regional Institute of Medical Sciences, Imphal |
Elective Surgery Operation Theatre complex (OT 5 and OT 9) Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal
Imphal West Manipur
Imphal West
MANIPUR |
9612989964
stephen33kamei@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board Regional Institute of Medical Sciences Imphal Manipurl |
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 |
Landmark- based supraclavicular brachial plexus block |
Participants will receive a single shot supraclavicular brachial plexus block by anatomical landmark technique using 20- 30ml of 0.5% ropivacaine performed once preoperatively and takes approximately 10- 20 minutes |
| Intervention |
Ultrasound- guided supraclavicular brachial plexus block |
Participants will receive a single shot supraclavicular brachial plexus block under ultrasound guidance using 20- 30ml of 0.5% ropivacaine performed once preoperatively and takes approximately 10-20 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with American Society of Anaesthesiologists (ASA) physical grade I or II
2.Patient who are able to understand pain scoring systems (e.g.VAS) |
|
| ExclusionCriteria |
| Details |
1. Any patient who refuse to give consent
2. Any infection at the block site
3. Patient with coagulopathy or on anti- coagulant therapy
4. Allergy to local anaesthetics
5. Pre- existing neuropathy or neurological deficit in upper limb
6. Pregnancy or lactation
7. Emergency surgeries
8. Patient with severe respiratory or cardiac disease |
|
|
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 |
| Block success rate |
Proportion of patients achieving complete sensory (Hollmen scale 4) and motor block (Hollmen scale 4) without rescue analgesia or conversion to general anaesthesia within 30 minutes after block administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Onset time of sensory and motor block |
1.Time from complete injection of local anaesthetics to attainment of Hollmen scale 3 of both sensory and motor block will be assess every 3 minutes upto 20 minutes |
| 2. Duration of analgesia |
2.Time from completion of block to first request for rescue analgesia hours postoperatively |
| 3.Efficacy of block |
3.Will be assess at the start of surgery and intraoperatively |
| 4.Incidence of complications |
4. Vascular puncture, pneumothorax, nerve injury, haematoma if present will be recorded intraoperative to 24 hours postoperatively |
| 5.Patient satisfaction score |
5. Likert scale 1-5 will be use to note patient satisfaction level within 24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
09/12/2025 |
| 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
|
The study entitled "A Comparative study of Ultrasound- guided versus Landmark- based supraclavicular brachial plexus block techniques in upper limb surgeries at Tertiary Care Setting" will be conducted among 74 patients undergoing upper limb surgeries in Anaesthesia Department of Regional Institute of Medical Sciences, Imphal, to compare the efficacy and safety of ultrasound - guided versus landmark- based techniques for performing supraclavicular brachial plexus block. These 74 patients will be randomly divided into two groups 37 each: Group U receiving block by real time ultrasound guidance and Group L receiving block by anatomical landmark technique. The supraclavicular brachial plexus block will be perform with 20-30 ml of 0.5% ropivacaine for both the groups. Key parameters recorded include, time taken to perform the block, onset and duration of sensory and motor block, patient satisfaction level and time requirement of rescue analgesia. Haemodynamic parameters and any adverse effects will also be recorded. The findings and observations made during the entire study will be tabulated, graphically depicted whenever possible, satistically analyzed and inference will be drawn. |