| CTRI Number |
CTRI/2025/08/092863 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study to demonstrate effectiveness between medicine without and with adjuvant given at axillary region |
|
Scientific Title of Study
|
A clinical comparative study of effects of ropivacaine and ropivacaine with dexmedetomidine as an adjuvant in ultrasound guided axillary plexus block in forearm and hand 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 Sarika Gupta |
| Designation |
Junior resident |
| Affiliation |
Lala Lajpat Rai Memorial Medical College Meerut |
| Address |
Department of Anaesthesia, Lala Lajpat Rai Memorial Medical College
Meerut
UTTAR PRADESH
250004
India |
| Phone |
7458988200 |
| Fax |
|
| Email |
shubhiub0u@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh kumar Manik |
| Designation |
Professor |
| Affiliation |
Lala Lajpat Rai Memorial Medical College Meerut |
| Address |
Department of Anaesthesia, Lala Lajpat Rai Memorial Medical College
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9634857368 |
| Fax |
|
| Email |
dr.yogeshkmanik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogesh kumar Manik |
| Designation |
Professor |
| Affiliation |
Lala Lajpat Rai Memorial Medical College Meerut |
| Address |
Department of Anaesthesia, Lala Lajpat Rai Memorial Medical College
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9634857368 |
| Fax |
|
| Email |
dr.yogeshkmanik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia LLRM medical college meerut 250004 |
|
|
Primary Sponsor
|
| Name |
LLRM medical college |
| Address |
Department of Anaesthesia,LLRM medical college,meerut,uttar pradesh |
| Type of Sponsor |
Other [] |
|
|
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 Sarika Gupta |
LLRM medical college |
Department of anaesthesia, Lala Lajpat Rai Memorial Medical
College
Meerut
UTTAR PRADESH |
7458988200
shubhiub0u@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the principal LLRM medical college Meerut,Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S529||Unspecified fracture of forearm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ini ropivacaine 0.5% + ini dexmedetomidine 0.5mcg/kg |
Inj ropivacaine 0.5% (19ml) + inj dexmedetomidine 0.5mcg/kg given after indetification of axillary artery ,placing needle in plane from anterior aspect and directed toward axillary artery and drug is deposited around nerves under ush guidance |
| Comparator Agent |
Inj ropivacaine 0.5% + 1cc normal saline |
Inj ropivacaine 0.5% 19 ml and 1cc normal saline given after identification of axillary artery , needle placed in plane from anterior aspect and directed toward axillary artery and drug is deposited under usg guidance |
| Intervention |
Ultrasound guided block |
Axillary plexus block with the help of ultrasound |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 &2 undergoing elective upper limb surgeries |
|
| ExclusionCriteria |
| Details |
Patient refusal, infection at injection site, coagulopathy, pregnancy, peripheral neuropathy,1st and 2nd degree heart block , known allergy or hypersensitive to local anaesthetic |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess duration of postoperative analgesia
Onset of sensor block & motor block
Duration of motor block
|
To assess onset of sensory and motor block at 5min,10min,15min,30min,60min,120min.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of postoperative analgesia, hemodynamically changes,any complications |
Hemodynamic changes at 5min,10min,15min,30min,60 mim |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/08/2025 |
| 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 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 is clinical comparative study of effect of ropivacaine and ropivacaine with dexmedetomidine as an adjuvant in ultrasound guided axillary plexus block in forearm and hand surgeries and assessing the postoperative analgesia and onset of sensory and motor block and also assess hemodynamic changes and complications if any during intraoperative and postoperative . We enrolled 30 patient in each group . |