| CTRI Number |
CTRI/2025/08/093650 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Using Dexamethasone with Local Anaesthetic to make Nerve Block last longer in Arm Surgery |
|
Scientific Title of Study
|
Effect of Addition of Dexamethasone to Mixture of 2% Lidocaine with Adrenaline and 0.5% Ropivacaine in Ultrasound Guided Supraclavicular Brachial Plexus Block for Upper Limb Orthopaedic Surgery;A Randomised Double Blind Controlled Trial. |
| Trial Acronym |
N IL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Khemraj Meena |
| Designation |
Senior Professor |
| Affiliation |
Department of Anaesthesiology R.N.T. Medical College Udaipur |
| Address |
Department of Anaesthesiology R.N.T. Medical College Udaipur, India.
Department of Anaesthesiology R.N.T. Medical College Udaipur , Court Chouraha Udaipur 313001 Rajasthan India.
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414759782 |
| Fax |
|
| Email |
Khemraj10@gmail,com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Khemraj Meena |
| Designation |
Senior Professor |
| Affiliation |
Department of Anaesthesiology R.N.T. Medical College Udaipur |
| Address |
Department of Anaesthesiology R.N.T. Medical College Udaipur India.
Department of Anaesthesiology R.N.T. Medical College Udaipur Court Chouraha Udaipur 313001 Rajasthan India.
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414759782 |
| Fax |
|
| Email |
Khemraj10@gmail,com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Khemraj Meena |
| Designation |
Senior Professor |
| Affiliation |
Department of Anaesthesiology R.N.T. Medical College Udaipur |
| Address |
Department of Anaesthesiology R.N.T. Medical College Udaipur. Rajasthan India.
Department of Anaesthesiology R.N.T. Medical College Udaipur, Court Chouraha Udaipur313001 Rajasthan India.
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414759782 |
| Fax |
|
| Email |
Khemraj10@gmail,com |
|
|
Source of Monetary or Material Support
|
| Orthopedic Main Operation Theater ,2ND gloor Trauma Building ,RNT Medical College,Udaipur (Rajasthan),INDIA ,Pin 313001 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Jagdish Kumar |
Rabindranath Tagore Medical College |
Orthopedic Main Operation Theater 2nd Floor Trauma Building,RNT Medical College ,Court Chouraha ,Udaipur -313001
Udaipur
RAJASTHAN |
8005606843
jskk298@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RNT MEDICAL COLLEGE AND CONTROLLER AND ATTACHED HOSPITAL UDAIPUR |
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 |
Mixture of Lidocaine with Adrenaline and Ropivacaine with Dexamethasone in USG guided Supraclavicular brechial plexus block |
Duration of analgesia is evaluated in Supraclavicular brechial plexus block with 2% Lidocaine with Adrenaline (10ml),0.5% Ropivacaine (15ml) with Dexamethasone (8mg) intrathecally. |
| Comparator Agent |
Mixture of Lidocaine with Adrenaline and Ropivacaine without Dexamethasone in USG guided Supraclavicular brechial plexus block |
Duration of analgesia is evaluated in Supraclavicular brechial plexus block with 2% Lidocaine with Adrenaline (10ml),0.5% Ropivacaine (15ml) without Dexamethasone intrathecally. |
| Intervention |
Supraclavicular Brachial plexus block |
Duration of analgesia is compared between mixture of 2 percentage Lidocaine with Adrenaline 10ml and 0.5 percentage Ropivacaine 15ml with or without Dexamethasone 8mg itrathecally in USG guided supraclavicular brechial plexus block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with American Society of Anaesthesiologist physical status 1-2, Scheduled for elective upper limb below mid humerus level of duration 1-2 hours orthopedic surgery |
|
| ExclusionCriteria |
| Details |
Patient refusal,uncooperative patient,infection at site of infection,history of allergy to the study drug,bleeding disorder and coagulopathies,history of convulsion ,sever neurological deficites. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in The Duration of Post Operative Analgesia |
0min,30min,1hr,3hr,6hr,9hr,12hr,18hr,24hr. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total Duration Of Sensory Block & Total Duration Of Motor Block |
0min,30min,1hr,3hr,6hr,9hr,12hr,18hr,24hr. |
|
|
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)
|
05/09/2025 |
| 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 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
|
The aim of the study will be comparative study of equal mixture of lidocaine with adrenaline and ropivacaine with or without dexamethasone under ultrasound guided supraclavicular brachial plexus block for upper limb surgeries with Primary Objective-DURATION OF ANALGESIA ( time to first rescue analgesia) and Secondary Objective -Onset and duration of sensory and motor block,Haemodynamic changes,success rate of block.This study will be conducted in patients who will fulfill the inclusion criteria will be enrolled in the study.Th30oup of ey will be randomaly allocated into two equal group of 30 patients in each group.
Group A: Patient will recieve USG guided Supraclavicular brachial plexus block with 2% lidocaine with adrenaline 10ml ;0.5% ropivacaine 15 ml and normal saline =30ml(Total volume ) Group B: Patient will recieve USG guided Supraclavicular brachial plexus block with 2% lidocaine with adrenaline 10ml; 0.5% ropivacaine 15 ml with dexamethasone 8 mg and normal saline=30ml(Total volume) 0 |