| CTRI Number |
CTRI/2026/01/102462 [Registered on: 29/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| 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 numbing medicines with painkiller injection for arm surgery using ultrasound guidance |
|
Scientific Title of Study
|
Ultrasound guided Supraclavicular block : Comparison of efficacy between Ropivacaine(0.5%) with fentanyl and Bupivacaine (0.5%) with fentanyl 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 Harshavarthini M |
| Designation |
Postgraduate MD Anaesthesiology |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical college and hospital |
| Address |
Room no.14,Department of Anaesthesiology,Vinayaka Missions Kirupananda Variyar medical college and hospital,Salem
Salem
TAMIL NADU
636308
India |
| Phone |
7598575274 |
| Fax |
|
| Email |
manuharsha21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Senthil M |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar medical college and hospital |
| Address |
Room no 14 Department of Anaesthesiology,Vinayaka Missions Kirupananda Variyar medical college and hospital,Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9843127550 |
| Fax |
|
| Email |
marappansenthil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Senthil M |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar medical college and hospital |
| Address |
Room no 14 Department of Anaesthesiology,Vinayaka Missions Kirupananda Variyar medical college and hospital,Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9843127550 |
| Fax |
|
| Email |
marappansenthil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Kirupananda Variyar medical college and hospital,chinnaseergapadi,salem 636308,Tamilnadu,India |
|
|
Primary Sponsor
|
| Name |
Dr Harshavarthini M |
| Address |
Department of Anaesthesiology, Vinayaka Missions Kirupananda Variyar medical college and hospital,Chinnaseergapadi,salem 636308,Tamilnadu,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 Harshavarthini M |
Vinayaka Missions Kirupananda Variyar medical college and hospital |
Room no.14,Department of Anaesthesiology, Vinayaka Missions Kirupananda Variyar medical college and hospital,Salem
Salem
TAMIL NADU |
7598575274
manuharsha21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Y998||Other external cause status, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bupivacaine 0.5 percent 20 millilitre with Fentanyl 50 microgram |
ultrasound-guided supraclavicular brachial plexus block will be performed. Participants will receive the allocated drug as per group assignment: Group B: 0.5 percent Bupivacaine 20 millilitre + fentanyl 50 microgram will be injected perineurally around brachial plexus. Hemodynamic parameters will be monitored every 15 minutes. Sensory and motor block characteristics, duration of surgery, need for rescue analgesia, and any adverse events will be recorded. |
| Comparator Agent |
Ropivacaine 0.5 20 millitre with Fentanyl 50 microgram |
ultrasound-guided supraclavicular brachial plexus block will be performed. Participants will receive the allocated drug as per group assignment: Group R: 0.5 percent ropivacaine 20 millilitre + fentanyl 50 microgram will be injected perineurally around brachial plexus. Hemodynamic parameters will be monitored every 15 minutes. Sensory and motor block characteristics, duration of surgery, need for rescue analgesia, and any adverse events will be recorded |
| Intervention |
Ultrasound guided Supraclavicular block In upper limb surgeries |
Supraclavicular approach to to anaesthetise brachial plexus with guidance of ultrasound in upper limb surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient consent to participate in the study
Age 18-65 years
ASA physical status I and II
Elective upper limb surgeries under supraclavicular block |
|
| ExclusionCriteria |
| Details |
Patient refusal to participate in the study
Coagulopathy
Allergy to study drugs
Infection at injection site
Pregnancy/lactation
Neurological or psychiatric disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of sensory and motor blockade between 0.5% Ropivacaine with Fentanyl and 0.5% Bupivacaine with Fentanyl when used for ultrasound-guided supraclavicular brachial plexus block in upper limb surgeries. |
From onset of Supraclavicular brachial plexus blockade before surgery to post operative day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the onset time of sensory and motor block between the two drug combinations
To evaluate the duration of postoperative analgesia provided by each drug.
To assess the quality of block in terms of effectiveness and surgical conditions
To monitor and compare the incidence of adverse effects or complications (
bradycardia, local anesthetic toxicity,hypotension)
To compare patient satisfaction and surgeon satisfaction with the anesthetic technique. |
From onset of blockade before surgery to post operative day 1 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
16/02/2026 |
| 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 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
|
This study aims to evaluate the effectiveness and safety of the proposed intervention in improving perioperative outcomes among patients undergoing surgery under anaesthesia. Eligible participants will be recruited based on predefined inclusion and exclusion criteria after obtaining informed consent. The study will follow an appropriate observational/interventional design with systematic data collection on demographic variables, clinical parameters, and outcome measures. Standard anaesthetic and monitoring protocols will be adhered to throughout the study period. Data will be analyzed using suitable statistical methods to assess primary and secondary outcomes. The findings are expected to contribute valuable evidence to improve anaesthetic management and patient safety in clinical practice. |