| CTRI Number |
CTRI/2025/07/091909 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effects of Dexamethasone and Dexmedetomidine when added to local anesthetics for pain relief during upper limb surgeries using an ultrasound-guided nerve block. |
|
Scientific Title of Study
|
A Study comparing Dexamethasone and Dexmedetomidine as adjuvants with Bupivacaine and Lignocaine and Adrenaline 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 KOUSIKA K |
| Designation |
POSTGRADUATES,DEPARTMENT OF PHARMACOLOGY |
| Affiliation |
SHRI ATAL BIHARI VAJPAYEE MEDICAL COLLEGE AND RESEARCH INSTITUTE,BANGALORE-560001 |
| Address |
Department of Pharmacology,
1, Lady Curzon Road,
Shivajinagar,
Bengaluru
Bangalore
KARNATAKA
560001
India |
| Phone |
8072982193 |
| Fax |
|
| Email |
kousika.kathirvel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr NALINI G K |
| Designation |
Professor & Head of the Department of Pharmacology |
| Affiliation |
Professor & HOD, Department of Pharmacology, SABVMCRI, Bengaluru, Karnataka, India |
| Address |
Department of Pharmacology,
1, Lady Curzon Road,
Shivajinagar,
Bengaluru
Bangalore
KARNATAKA
560001
India |
| Phone |
8072982193 |
| Fax |
|
| Email |
nskargk97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr KOUSIKA K |
| Designation |
POSTGRADUATE,DEPARTMENT OF PHARMACOLOGY |
| Affiliation |
POSTGRADUATE,DEPARTMENT OF PHARMACOLOGY,SHRI ATAL BIHARI VAJPAYEE MEDICAL COLLEGE AND RESEARCH INSTITUTE,BANGALORE-560001 |
| Address |
Department of Pharmacology,
1, Lady Curzon Road,
Shivajinagar,
Bengaluru
Bangalore
KARNATAKA
560001
India |
| Phone |
8072982193 |
| Fax |
|
| Email |
kousika.kathirvel@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr KOUSIKA K |
| Address |
SHRI ATAL BIHARI VAJPAYEE MEDICAL COLLEGE AND RESEARCH INSTITUTE,1,LADY CURZON Rd,SHIVAJI NAGAR, BENGALURU,KARNATAKA. |
| Type of Sponsor |
Other [self] |
|
|
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 KOUSIKA K |
LADY CURZON AND BOWRING HOSPITAL,SHRI ATAL BIHARI VAJPAYEE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
Department of Pharmacology,
1, Lady Curzon Road,
Shivajinagar,
Bengaluru
Bangalore
KARNATAKA |
8072982193
kousika.kathirvel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE OF SHRI ATAL BIHARI VAJPAYEE MEDICAL COLLEGE & RESEARCH INSTITUTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, (2) ICD-10 Condition: G540||Brachial plexus disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexamethasone as adjuvants with Bupivacaine and Lignocaine with Adrenaline |
10 ml of 2% Lignocaine + 10 ml of 0.5% Bupivacaine + 0.1 ml Adrenaline 1:1000 + 4 mg Dexamethasone |
| Comparator Agent |
Dexmedetomidine as adjuvants with Bupivacaine and Lignocaine with Adrenaline |
10 ml of 2% Lignocaine + 10 ml of 0.5% Bupivacaine + 0.1 ml Adrenaline 1:1000 + 50 µg Dexmedetomidine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients aged 18 to 65 years undergoing elective upper limb surgeries under Ultrasound guided supraclavicular brachial plexus block.
2. Patients classified as American Society of Anesthesiologists physical status I or II.
3. Patients willing to undergo Ultrasound-guided supraclavicular brachial plexus block.
4. Patients who provide written informed consent for participation in the study.
5. Patients with normal coagulation profile PT,APTT ,no bleeding diasthesis, platelet count more than 1 lakh and no contraindication to regional anesthesia.
|
|
| ExclusionCriteria |
| Details |
1. Patients with known allergy or hypersensitivity to local anesthetics,Adrenaline, Dexamethasone, or Dexmedetomidine.
2. Patients with coagulopathy or on anticoagulant therapy.
3. Patients with infection at the site of block or local skin infections Abscess, Hematoma, Folliculitis, Impetigo etc
4. Patients with pre-existing neurological deficits in the upper limb to be operated.
5. Patients with cardiopulmonary disease e.g., uncontrolled hypertension, ischemic heart disease, heart failure, COPD.
6. Pregnant or lactating women.
7. BMI more than 40 kg per m² morbid obesity making ultrasound-guided block difficult.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare the onset time of sensory and motor blockade.
2. To compare the duration of sensory and motor blockade.
3. To evaluate the incidence and type of adverse drug reactions associated with each adjuvant.
|
0 hour
15min
30min
45min
60min
90min
120min
3hour
4 hour
5 hour
6 hour
7 hour
8 hour
9 hour
10 hour
11 hour
TILL VAS MORE THAN OR EQUALTO 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the pharmacological interactions between local anesthetics and Dexmedetomidine and Dexamethasone in producing neuronal blockade.
2.To assess the hemodynamic effects as indicators of systemic pharmacological effects of Dexamethasone and Dexmedetomidine
|
0 hour
15min
30min
45min
60min
90min
120min
3hour
4 hour
5 hour
6 hour
7 hour
8 hour
9 hour
10 hour
11 hour
TILL VAS SCORE MORE THAN 4 |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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)
|
11/08/2025 |
| 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="3"
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 study aims to compare the efficacy and safety of Dexamethasone versus Dexmedetomidine when used as adjuvants with Bupivacaine, Lignocaine, and Adrenaline in ultrasound-guided supraclavicular brachial plexus block for upper limb surgeries. A randomized controlled trial design will be followed with 98 adult patients divided into two groups of 49 each. Group 1 will receive Dexamethasone, and Group 2 will receive Dexmedetomidine as adjuvants. The primary outcomes include onset and duration of sensory and motor block, and incidence of adverse drug reactions. Secondary outcomes include hemodynamic effects and pharmacological interactions. Patients will be monitored for complications such as bradycardia, hypotension, and nerve injury. Data will be analyzed using standard statistical methods to determine which adjuvant provides superior block characteristics and safety profile. This research will help optimize postoperative analgesia and enhance patient recovery. |