| CTRI Number |
CTRI/2025/02/080286 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of delivery of drugs through two different routes in surgery of upper extremities |
|
Scientific Title of Study
|
A prospective randomised comparative study of intravenous and perineural dexamethasone as an adjuvant to levobupivacaine in ultrasound guided supraclavicular block in adult patients undergoing elective 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 |
Rashmi Soni |
| Designation |
Junior resident |
| Affiliation |
Lala Lajpat Rai Memorial Medical College Meerut |
| Address |
Department of Anaesthesia, Lala Lajpat Rai Memorial Medical College Meerut, Uttar Pradesh, India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8755785322 |
| Fax |
|
| Email |
singharunrashmi1991@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sweta |
| Designation |
Associate Professor |
| Affiliation |
Lala Lajpat Rai Memorial Medical College Meerut |
| Address |
Department of Anaesthesia, Lala Lajpat Rai Memorial Medical College Meerut, Uttar Pradesh, India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8750933442 |
| Fax |
|
| Email |
swetaanae@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rashmi Soni |
| Designation |
Junior Resident |
| Affiliation |
Lala Lajpat Rai Memorial Medical College Meerut |
| Address |
Department of Anaesthesia, Lala Lajpat Rai Memorial Medical College Meerut, Uttar Pradesh, India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8755785322 |
| Fax |
|
| Email |
singharunrashmi1991@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia LLRM Medical College , Meerut, PIN- 250004 |
|
|
Primary Sponsor
|
| Name |
LLRM Medical College, Meerut |
| Address |
Department of Anaesthesia LLRM Medical College , Meerut, PIN- 250004 |
| 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 Rashmi Soni |
Lala Lajpat Rai Memorial Medical College , Meerut |
Department of Anaesthesia, Lala Lajpat Rai Memorial Medical College Meerut, Uttar Pradesh, India
Meerut
UTTAR PRADESH |
08755785322
singharunrashmi1991@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
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 |
Inj. Levobupivacaine given perineural with i.v. dexamethasone |
Inj. Levobupivacaine 0.5%(19ml)+ 1 cc normal saline - total volume 20ml given perineural with 4mg dexamethasone given intravenously |
| Comparator Agent |
Inj. Levobupivacaine with dexamethasone given perineural |
Inj. Levobupivacaine 0.5%(19ml)+ dexamethasone(4mg,1ml)-total volume 20cc given perineural with 1ml iv normal saline |
| Intervention |
USG guided supraclavicular block |
Drug is given by supraclavicular block under USG guidance and patient was observed post operatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1 and 2 patients, patients undergoing elective upper limb surgeries, BMI between 18-24 kg/meter square |
|
| ExclusionCriteria |
| Details |
Patient refusal, infection at injection site , coagulopathy , pregnancy , 1st/2nd/3rd degree heart block, peripheral neuropathy ,known allergy or hypersensitivity to local anaesthetic drug. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to complete sensory and motor blockade , duration of post op analgesia , onset of sensory block , onset of motor block , duration of motor blockade , haemodynamic changes , complications |
Sensory and motor blocks will be evaluated every 10 minutes until 30 minutes after injection and then every 30 minute until completion of surgery and the patient was evaluated postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haemodynamic changes , complications |
After 5 minutes, 10 minutes , 15 minutes, 30 minutes, 60 minutes, 120 minutes |
|
|
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)
|
15/02/2025 |
| 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="1"
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
|
IT IS A COMPARATIVE STUDY OF INTRAVENOUS AND PERINEURAL DEXAMETHASONE AS AN ADJUVANT TO LEVOBUPIVACAINE IN ULTRASOUND GUIDED SUPRACLAVICULAR BLOCK IN ADULT PATIENTS UNDERGOING ELECTIVE UPPERLIMB SURGERIES .WE COMPARED TIME TO COMPLETE SENSORY AND MOTOR BLOCK , DURATION OF POST OP ANALGESIA , ONSET OF SENSORY AND MOTOR BLOCKADE. WE ALSO COMPARED HAEMODYNAMIC CHANGES AND ANY COMPLICATIONS ASSOCIATED WITH THE PROCEDURE. |