| CTRI Number |
CTRI/2024/01/061339 [Registered on: 10/01/2024] Trial Registered Prospectively |
| Last Modified On: |
19/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Efficacy of perineural Dexmedetomidine As an adjuvant to bupivacaine in ultrasound guided supraclavicular block for upper limb surgery randomised control trail |
|
Scientific Title of Study
|
efficacy of perineural dexmedetomidine as a adjuvant to Bupivacaine with Ultrasound-guided supraclavicular block for upper limb surgery Randomized control trail |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M Senthil Vadivel Raj |
| Designation |
Postgraduate |
| Affiliation |
Aarupadai Veedu medical college and hospital |
| Address |
A block department of anaesthesia Aarupadai Veedu medical college and hospital kirumampakkam Puducherry
A block department of anaesthesia Aarupadai Veedu medical college and hospital kirumampakkam Puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9940506477 |
| Fax |
|
| Email |
Senthil007raj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Haribabu Veeraraghavan |
| Designation |
Professor |
| Affiliation |
Aarupadai Veedu medical college and hospital |
| Address |
A block department of anaesthesia Aarupadai Veedu medical college and hospital kirumampakkam Puducherry
A block department of anaesthesia Aarupadai Veedu medical college and hospital kirumampakkam Puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9442369647 |
| Fax |
|
| Email |
Veeraraghavanharibabu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Haribabu Veeraraghavan |
| Designation |
Professor |
| Affiliation |
Aarupadai Veedu medical college and hospital |
| Address |
A block department of anaesthesia Aarupadai Veedu medical college and hospital kirumampakkam Puducherry
A block department of anaesthesia Aarupadai Veedu medical college and hospital kirumampakkam Puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9442369647 |
| Fax |
|
| Email |
Veeraraghavanharibabu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aarupadai Veedu medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Aarupadai Veedu medical college and hospital |
| Address |
A block department of anaesthesia Aarupadai Veedu medical college and hospital kirumampakkam Puducherry |
| 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 |
| M Senthil Vadivel Raj |
Aarupadai Veedu medical college and hospital |
A block department of anaesthesia Aarupadai Veedu medical college and hospital kirumampakkam Puducherry
Pondicherry
PONDICHERRY |
9940506477
Senthil007raj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human ethical 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 |
Dexmedetomidine as an adjuvant with bupivacaine for duration and post analgesic effect |
Dexmedetomidine as adjuvant with bupivacaine for supraclavicular block for upper limb surgery |
| Comparator Agent |
To compare efficacy of Dexmedetomidine as adjuvant to bupivacaine vs plain bupivacaine |
29ml of 0.5% bupivacaine with 1 ml of Dexmedetomidine 50mcq |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 65yr
ASA 1 AND 2
patient undergoing upper limb surgery under supraclavicular block |
|
| ExclusionCriteria |
| Details |
ASA 3 and above
Patient with heart block and left heart failure
Haematological disease bleeding disorder coagulation disorder
Psychiatric disorder
Allergy to Dexmedetomidine
Patient refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess Duration of anaesthesia effect of dexmedetomidine 5min |
Till the onset of pain 30min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess post operative analgesia for the patient undergoing surgery for upper limb with supraclavicular block (5min) |
To assess post operative analgesia for the patient undergoing surgery for upper limb with supraclavicular block (30min) |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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 4 |
|
Date of First Enrollment (India)
|
10/01/2024 |
| 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 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- 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 [Senthil007raj@gmail.com].
- For how long will this data be available start date provided 15-05-2023 and end date provided 01-05-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Efficacy of perineural Dexmedetomidine as a adjuvant to bupivacaine in ultrasound guided supraclavicular block for upper limb surgery a randomised control trail |