| CTRI Number |
CTRI/2025/03/082208 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Two dose 4mg and 8mg of dexamethasone in supraclavicular brachial plexus block with 0.5% bupivacaine in upper limb surgeries for onset duration and postop analgesia |
|
Scientific Title of Study
|
Comparison of Dexamethasone 4 mg and 8 mg as an Adjuvant to 0.5% Bupivacaine in Supraclavicular Brachial Plexus Block for 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 |
Dr Jigneshkumar chauhan |
| Designation |
Postgraduate resident in anaesthesiology |
| Affiliation |
B.J. Medical College and Civil Hospital , Ahmedabad |
| Address |
F3, First floor, Department of anaesthesiology, Civil hospital, Asarwa, Ahmedabad Ahmadabad GUJARAT 380016 India
Ahmadabad
GUJARAT
380016
India |
| Phone |
9725667115 |
| Fax |
|
| Email |
chauhanjignesh1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramila Jamaliya |
| Designation |
Professor(H.G) |
| Affiliation |
B.J. Medical College and Civil Hospital , Ahmedabad |
| Address |
F3, First floor, Department of anaesthesiology, Civil hospital, Asarwa, Ahmedabad Ahmadabad GUJARAT 380016 India
Ahmadabad
GUJARAT
380016
India |
| Phone |
9427702172 |
| Fax |
|
| Email |
ramilajamliya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramila Jamaliya |
| Designation |
Professor(H.G) |
| Affiliation |
B.J. Medical College and Civil Hospital , Ahmedabad |
| Address |
F3, First floor, Department of anaesthesiology, Civil hospital, Asarwa, Ahmedabad Ahmadabad GUJARAT 380016 India
Ahmadabad
GUJARAT
380016
India |
| Phone |
9427702172 |
| Fax |
|
| Email |
ramilajamliya@gmail.com |
|
|
Source of Monetary or Material Support
|
| B.J.Medical College and Civil Hospital, Government of Gujarat, Asarwa, Ahmedabad, Gujarat, India, 380016 |
|
|
Primary Sponsor
|
| Name |
Government of Gujurat |
| Address |
7th floor, Health and family welfare department, Sachivalaya, Gandhinagar, Gujarat, India, 382010 |
| 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 Jigneshkumar chauhan |
B.J.Medical College and Civil Hospital , Ahmedabad |
Department of anaesthesia, Room number O3 , third floor, Pediatric surgery operation theatre, 1200 bed hospital, Asarwa, Ahmedabad 380016 Ahmadabad GUJARAT
Ahmadabad
GUJARAT |
9725667115
chauhanjignesh1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee , B.J.Medical College and Civil Hiospital , Ahmedabad |
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 4 mg with BUPIVACAINE 0.5% Plain 20 ml in supraclavicular brachial plexus block. |
20ml 0.5% Bupivacaine with 4 mg dexamethasone as adjuvant given as stat dose in supraclavicular brachial plexus block via blind approch in studying effectiveness in duration ; onset and Post operative pain relief in 24 hour. |
| Intervention |
Dexamethasone 8 mg with BUPIVACAINE 0.5% Plain 20 ml in supraclavicular brachial plexus block. |
20ml 0.5% Bupivacaine with 8 mg dexamethasone as adjuvant given as stat dose in supraclavicular brachial plexus block via blind approch in studying effectiveness in duration ; onset and Post operative pain relief in 24 hour. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA grade : I,II,III
2. Elective upper limb surgeries under
supraclavicular brachial plexus block.
3. Patient giving consent. |
|
| ExclusionCriteria |
| Details |
1. Any bleeding disorder and patient on
anticoagulants
2. Contralateral lung injury and rib fracture
3. Pre-existing neuropathy involving the surgical
limb
4. Local infection at the injection site
5. History of allergy to local anaesthetic and
dexamethasone
6. Patients with a history of peptic ulcer
disease, hepatic or renal failure
(contraindication to steroids)
7. Pregnant women
8. Systemic use of corticosteroids for 2 weeks or
longer within 6 months of surgery
9. Unwilling patient |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare duration and onset of sensory and motor blockage in both group |
To compare duration and onset of sensory and motor blockage in both group starting from baseline to every 3 min with 3 point scale method. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare hemodynamic parameter intraoperative and To compare complication intraoperative and postoperative in both group |
24 hour postoperative |
|
|
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)
|
18/03/2025 |
| 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
|
Brachial plexus block has evolved as an important tool as a safe alternative to general anaesthesia for upper limb surgery and peri-operative analgesia.Bupivacaine is a potent local anaesthetic drug widely used for prolonged local and regional anaesthesia.Many additives can be added to local anaesthetics such as opioids, clonidine, tramadol, dexmedetomidine, dexamethasone that have been used to increase the duration of the block, to improve the postoperative pain management.In this study we compare duration of analgesia, onset and duration of sensory and motor block and hemodynamic parameters in supraclavicular brachial plexus block with Dexamethasone 4mg and 8mg as an adjuvant to 0.5% Bupivacaine. |