| CTRI Number |
CTRI/2025/10/095958 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Two Different Amounts of a Drug (Dexmedetomidine) Added to a Numbing Medicine (Bupivacaine) for Better Pain Relief During Arm Surgery Using an Ultrasound-Guided Nerve Block |
|
Scientific Title of Study
|
Comparison of two doses of Dexmedetomidine as an adjuvant to Bupivacaine 0.5% in USG guided Supraclavicular Brachial Plexus Block: A Double Blind Randomised controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Adithya V |
| Designation |
Post graduate resident |
| Affiliation |
School of medical sciences and research Sharda hospital Sharda university |
| Address |
Department of Anaesthesiology School of medical sciences and research Sharda hospital Sharda university knowledge park 3 greater noida gautam buddha nagar
Uttar Pradesh
201310
India
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8848143115 |
| Fax |
|
| Email |
adithyav70@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shaista Jamil |
| Designation |
Associate Professor |
| Affiliation |
School of medical sciences and research,Sharda university |
| Address |
Department of Anaesthesiology School of medical sciences and research Sharda hospital Sharda university knowledge park 3 greater noida gautam buddha nagar
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8750368756 |
| Fax |
|
| Email |
docshaistajamil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shaista Jamil |
| Designation |
Associate Professor |
| Affiliation |
School of medical sciences and research,Sharda university |
| Address |
Department of Anaesthesiology School of medical sciences and research Sharda hospital Sharda university knowledge park 3 greater noida gautam buddha nagar
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8750368756 |
| Fax |
|
| Email |
docshaistajamil@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
School of medical sciences and research Sharda hospital Sharda university |
| Address |
Knowledge park 3,Greater Noida,Gautam Buddha Nagar,Uttar Pradesh |
| 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 |
| Adithya V |
Department of Anaesthesiology |
Department of Anaesthesiology School of medical sciences and research Sharda hospital Sharda university knowledge park 3 greater noida gautam buddha nagar
Uttar Pradesh
201310
India
Gautam Buddha Nagar
UTTAR PRADESH |
08848143115
adithyav70@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,School of medical sciences and research,Sharda university,Greater Noida |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine |
As per the allocated group, a prepared drug solution will be injected, and the drug solution will be observed in the tissue plane under ultrasound imaging. Distension of the brachial plexus sheath will be regarded as an indication of a successful block. |
| Intervention |
Supraclavicular brachial plexus block |
Supraclavicular brachial plexus block will be administered with patient in supine position, patients head will be turned 45 degrees to the opposite side |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective upper limb surgery.
Age between 18 to 65 years.
ASA physical status class 1 and 2
|
|
| ExclusionCriteria |
| Details |
History of allergy or hypersensitivity to local anaesthetic
Local infection at the site of injection
Refusal to consent
Patients with coagulation disorders
Pregnancy
Morbid obesity
History of coronary artery disease, chronic renal and hepatic disease
Seizure disorder
Psychiatric disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of two doses of Dexmedetomidine as an adjuvant to Bupivacaine 0.5% in ultrasound-guided supraclavicular brachial plexus block in upper limb surgery |
To compare the duration of analgesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the onset and duration of sensory and motor block 2. To compare the rescue analgesic requirements in 24hrs
3.To compare the intraoperative sedation score
4. To compare the intraoperative haemodynamic parameters
5.To compare the incidence of side effects if any
|
Peri operative monitoring till 24hours post operatively |
|
|
Target Sample Size
|
Total Sample Size="99"
Sample Size from India="99"
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
|
N/A |
|
Date of First Enrollment (India)
|
14/08/2030 |
| 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)
|
Not Yet Recruiting |
| 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 randomised double blinded controlled study aims to compare the two doses of Dexmedetomidine as an adjuvant to Bupivacaine 0.5% in USG guided supraclavicular brachial plexus block.A total of 60 Patients will be enrolled and divided in to three groups. The primary outcome will be assessed by hemodynamic parameters like HR,SBP,DBP,MAP,SPO2 at baseeline and at every 5mins for 1hour and 15mins till completion of surgery.The secondary outcome will be assessed using Pinprick method,modified bromage scsle,Sedation score,VAS score,complications like local anaaesthesia toxicity,phrenic nerve palsy,subcutaneous emphysema and pneumothorax.The goal is to evaluate comparison of efficacy of analgesia in two doses of Dexmedetomidine to Bupivacaine in upper limb surgeries |