| CTRI Number |
CTRI/2025/11/097041 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
30/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing two medications with local anaesthetic for pain relief in patients undergoing upperlimb surgeries with the help of ultrasound guided nerve block. |
|
Scientific Title of Study
|
A comparative study between dexmedetomidine and dexamethasone as adjuvants to 0.5 percent ropivacaine in ultrasound guided supraclavicular brachial plexus block. |
| 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 Harshitha N G |
| Designation |
Junior resident |
| Affiliation |
Sapthagiri Institute Of Medical Sciences |
| Address |
Department of Anaesthesiology Sapthagiri Institute of Medical Sciences and Research Centre Navy Layout, Hessaragatta main road, Chikkabanavara, Banglore ,Karnataka
Bangalore
KARNATAKA
560090
India |
| Phone |
9591869202 |
| Fax |
|
| Email |
harshithang444@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand Tipanna Talikoti |
| Designation |
Professor |
| Affiliation |
Sapthagiri Institute Of Medical Sciences and Research Centre |
| Address |
Department of Anaesthesiology Sapthagiri Institute of Medical Sciences and Research Centre Navy Layout, Hessaragatta main road, Chikkabanavara, Banglore ,Karnataka
Bangalore
KARNATAKA
560090
India |
| Phone |
9986093837 |
| Fax |
|
| Email |
drttanand@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anand Tipanna Talikoti |
| Designation |
Professor |
| Affiliation |
Sapthagiri Institute Of Medical Sciences and Research Centre |
| Address |
Department of Anaesthesiology Sapthagiri Institute of Medical Sciences and Research Centre Navy Layout, Hessaragatta main road, Chikkabanavara, Banglore ,Karnataka
Bangalore
KARNATAKA
560090
India |
| Phone |
9986093837 |
| Fax |
|
| Email |
drttanand@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology Sapthagiri Institute of Medical Sciences and Research Centre Navy Layout, Hessaragatta main road, Chikkabanavara, Banglore ,Karnataka,India 560090 |
|
|
Primary Sponsor
|
| Name |
Sapthagiri Institute of Medical Sciences and REsearch Centre |
| Address |
Department of Anaesthesiology Sapthagiri Institute of Medical Sciences and Research Centre Navy Layout, Hessaragatta main road, Chikkabanavara, Banglore ,Karnataka,India 560090 |
| Type of Sponsor |
Private 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 Harshitha N G |
Sapthagiri Institute of Medical Sciences and Research Centre |
Navy Layout, Hessaragatta main road, Chikkabanavara, Banglore ,Karnataka,India 560090
Bangalore
KARNATAKA |
9591869202
harshithang444@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sapthagiri Institute Of Medical Sciences and Research Centre |
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 |
Dexamethasone |
Pateint allocated in group B will receive 8mg of Dexamethasone as an adjuvant to 0.5 percent Ropivacaine in ultra sound gudided supraclavicular brachial plexus block. |
| Comparator Agent |
Dexmedetomidine |
Pateint allocated in group A will receive 50mcg of Dexmedetomidine as an adjuvant to 0.5 percent Ropivacaine in ultra sound gudided supraclavicular brachial plexus block. |
| Intervention |
Ultrasound guided supraclavicular brachial plexus block |
Using ultrasound guided technique supraclavicular brachial plexus block will be
performed using linear probe in plane approach. Patient will be made to lie in supine position and brachial plexus will be visualized using real time visualization of artery,
first rib, hypoechoic nodules.After identification of brachial plexus,under aseptic precautions using 22G needle block is performed.
Group A will receive:
Inj.Ropivacaine 0.5percent30ml and Inj.Dexmedetomidine 50mcg and INJ Normal saline 1.5ml.
Group B will receive :
Inj.Ropivacaine 0.5percent 30ml and Inj Dexamethasone 8mg 2ml.
Assessment done every 5mins for first 30mins thereafter 10mins for 2hrs and every 30mins till the end of surgery.Postoperatively sensory and motor block assessement and vital parameters will be recorded at 10mins 30mins and 1, 2, 4 ,6, 12 and 24hours after the surgery.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients undergoing unilateral upper limb surgeries.
2.Patient willing to give informed consent.
3.Age between 18yrs to 60yrs.
4.ASA-PS 1 and 2.
5.Weight more than 60kgs
|
|
| ExclusionCriteria |
| Details |
1.Patients refusal.
2.Allergy to local anesthetics and study drugs.
3.Local infections.
4.Bleeding disorders.
5.Patient with neurological psychiatric and neruormuscular disorders.
6.Patient with history of hepatic, renal, cardiopulmonary abnormalities.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Onset and duration of sensory block
2)Onset and duration of motor block
3)Time of rescue anlagesia
|
Every 5mins for first 30mins thereafter 10mins for 2hrs and every 30mins till the end of surgery.Postoperatively sensory and motor block assessement will be recorded at 10mins 30mins and 1, 2, 4 ,6, 12 and 24hours after the surgery.
|
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 |
|
Date of First Enrollment (India)
|
20/11/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
Modification(s)
|
Patients fulfilling the inclusion criteria and posted for upper limb surgeries will be assigned to either group A and group B through a computer-generated random numbers, maintaining a equal ratio. Group A patients will receive 30 ml of 0.5 percent Ropivacaine with Dexmedetomidine 50micrograms and Group B will receive 30 ml of 0.5 percent Ropivacaine with 8milligram of Dexamethasone. Under Ultrasound guidance supraclavicular brachial plexus block will be given, onset of sensory and motor block will be noted. Duration of sensory and motor block will be assessed 5mins for first 30mins thereafter 10mins for 2hrs and every 30mins till the end of surgery. Post-operatively, sensory and motor blockade and vital parameters will be recorded at 10mins 30mins and 1, 2, 4 ,6, 12 and 24hours after the surgery.The block will be considered incomplete when any of the segments supplied by median, radial, ulnar and musculocutaneous nerve did not have analgesia even after 30min of drug injection. Then such patients will be converted to general anaesthesia and will be excluded from the study. There is limited literature available comparing Dexmedetomidine and Dexamethasone as an adjuvant to ropivacaine in supraclavicular brachial plexus block. Hence, the present study will be undertaken to compare the efficacy of Dexmedetomidine and Dexamethasone as an adjuvant to ropivacaine in supraclavicular brachial plexus block in terms of onset and duration of sensory and motor block and duration of post operative analgesia. |