| CTRI Number |
CTRI/2024/05/067262 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
13/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare drug having pain relieving action given via regional method versus given intravenously after block in patients undergoing forearm surgeries |
|
Scientific Title of Study
|
A prospective study of comparison of analgesic efficacy of perineural dexamethasone as an adjuvant in supraclavicular block versus intravenous dexamethasone and paracetamol after supraclavicular block in patients undergoing forearm 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 |
Rashmi Kelkar |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Dr. D.Y.Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anaesthesia,
5th Floor, Hi-tech building,
Dr. D.Y.Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7767981911 |
| Fax |
|
| Email |
rashmikelkar@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chhaya Suryawanshi |
| Designation |
HOD and Professor, Department of Anesthesiology |
| Affiliation |
DR. D.Y.PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PIMPRI, PUNE |
| Address |
Department of Anaesthesia,
5th Floor, Hi-tech building,
Dr. D.Y.Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9922888201 |
| Fax |
|
| Email |
chhayasuryawanshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chhaya Suryawanshi |
| Designation |
HOD and Professor, Department of Anesthesiology |
| Affiliation |
DR. D.Y.PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PIMPRI, PUNE |
| Address |
Department of Anaesthesia,
5th Floor, Hi-tech building,
Dr. D.Y.Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9922888201 |
| Fax |
|
| Email |
chhayasuryawanshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central pharmacy,5th floor, Hi-tech building, Dr. D.Y.Patil Medical college, Hospital and Research Centre, Sant Tukaram nagar, Pimpri, Pune, Maharashtra, India
Pincode - 411018 |
|
|
Primary Sponsor
|
| Name |
Rashmi Kelkar |
| Address |
Department of Anaesthesia,
5th Floor, Hi-tech building,
Dr. D.Y.Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune |
| 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 |
| Rashmi Kelkar |
Dr. D.Y. Patil Hospital and Research Centre |
Department of Anaesthesia,
5th Floor, Hi-tech building,
Dr. D.Y.Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune 411018
Pune
MAHARASHTRA |
7767981911
rashmikelkar@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub-Committee |
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 |
| Intervention |
Dexamethason |
Perineural dexamethasone 8mg given in supraclavicular block, for the duration of surgery lasting 3-4 hours |
| Comparator Agent |
DEXAMETHASONE |
Intravenous dexamethasone 8mg and intravenous paracetamol 1gm given after supraclavicular block, for the duration of surgery lasting 3-4 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA grade 1 and ASA grade 2 fit patients.
2.Patients posted for upper limb surgeries below shoulder
3. Hemodynamically stable patients with all routine investigations within normal limits.
4. Written informed consent from the concerned patients.
|
|
| ExclusionCriteria |
| Details |
Patients whose parents are not willing to participate in the study.
2. Patients with ASA grade III and above physical status.
3. Patients who are aged more than 60 years and less than 18 years of age
4. Patients with known allergy to the study drugs.
5. Patients with bleeding disorders and those on anticoagulant therapy
6. Infection at site of block
7. Neurodeficit involving brachial plexus
8. Pregnant women
9. Patients with psychiatric behavior |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the analgesic efficacy of perineural dexamethasone as an adjuvant in supraclavicular block versus intravenous dexamethasone and paracetamol after supraclavicular block in patients undergoing forearm surgeries. |
After administration of the block, comparison between the two groups of onset and duration of sensory and motor blockade, duration of analgesia and time to rescue to analgesia will be assessed at baseline, after injection of study drug, at 5 mins, 10 mins, 15 mins, 30 mins and 10 mins after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the analgesic efficacy of perineural dexamethasone as an adjuvant in supraclavicular block versus intravenous dexamethasone & paracetamol after supraclavicular block in patients undergoing forearm surgeries. |
Duration of analgesia will be assessed post surgery once the effects of the block decrease & time to rescue to analgesia will be assessed 2 hours after surgery & hourly until intervention is required |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/05/2024 |
| Date of Study Completion (India) |
30/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/04/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [rashmikelkar@hotmail.com].
- For how long will this data be available start date provided 01-06-2024 and end date provided 31-12-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
It is a prospective, randomized, double blinded comparative study to compare the analgesic efficacy of perinueral dexamethasone as an adjuvant in supraclavicular block versus intravenous dexamethasone and paracetamol after supraclavicular block in patients undergoing forearm surgeries. Parameters that will be compared between the two groups will be the onset and duration of action of sensory and motor blockade, duration of analgesia and time to rescue analgesia. |