| CTRI Number |
CTRI/2024/12/078757 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
30/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The effect of injection dexmedetomidine added to dexamethasone in patients receiving surgery for arm fracture fixation under local pain relief. |
|
Scientific Title of Study
|
The effect of intravenous dexmedetomidine added to dexamethasone in patients undergoing proximal humeral fracture fixation under interscalene block: A double blind randomized placebo controlled trial. |
| 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 Vikram Bedi |
| Designation |
Senior professor |
| Affiliation |
RNT MEDICAL COLLEGE |
| Address |
Department of Anaesthesia, RNT MEDICAL COLLEGE UDAIPUR,
RAJASTHAN 313001 INDIA
Department of Anaesthesia, RNT MEDICAL COLLEGE UDAIPUR,
RAJASTHAN 313001 INDIA
Udaipur
RAJASTHAN
313001
India |
| Phone |
9829025373 |
| Fax |
|
| Email |
Vbedimd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikram Bedi |
| Designation |
Senior professor |
| Affiliation |
RNT MEDICAL COLLEGE |
| Address |
Department of Anesthesia,RNT MEDICAL COLLEGE UDAIPUR,
RAJASTHAN 313001 INDIA
Department of Anesthesia,RNT MEDICAL COLLEGE UDAIPUR,
RAJASTHAN 313001 INDIA
Udaipur
RAJASTHAN
313001
India |
| Phone |
9829025373 |
| Fax |
|
| Email |
Vbedimd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubhanshu Vashishtha |
| Designation |
PG resident |
| Affiliation |
RNT Medical college udaipur , Rajasthan |
| Address |
Department of Anaesthesiology RNT Medical college, Udaipur, Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
6377292948 |
| Fax |
|
| Email |
shubhanshuvashistha009@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, RNT Medical college, Udaipur, Rajasthan-313001, India |
|
|
Primary Sponsor
|
| Name |
Maharana Bhupal Government Hospital |
| Address |
Department of anaesthesiology, RNT Medical college,Udaipur,rajasthan,India-313001 |
| 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 vikram bedi |
Maharana bhupal Government Hospital |
Orthopaedic operation theater, 2nd Floor, Polytrauma Building,MB Hospital and RNT Medical College,Udaipur
Rajasthan-313001
Udaipur
RAJASTHAN |
9829025373
Vbedimd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RNT MEDICAL COLLEGE AND CONTROLLER AND ATTACHED HOSPITALS UDAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: S422||Fracture of upper end of humerus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Duration of post operative analgesia comparison |
To determine duration of post-operative analgesia in patient receiving single dose intravenous dexmedetomidine added to dexamethasone over 10 minutes when compared to patient receiving intravenous dexamethasone added to normal saline after interscalene block in ORIF proximal humeral fracture upto 24 hours. |
| Comparator Agent |
Intravenous dexamethasone for post-operative analgesia. |
After giving interscalene block intravenous dexamethasone (0.15mg/kg) in 100ml normal saline given over 10 minutes and post-operative analgesia is noted upto 24 hours |
| Comparator Agent |
Intravenous dexmedetomidine for post-operative analgesia. |
After giving interscalene block intravenous dexmedetomidine (1mcg/kg) in 100ml normal saline given over 10 minutes and post-operative analgesia is noted upto 24 hours |
| Comparator Agent |
Intravenous dexmedetomidine with dexamethasone for post-operative analgesia. |
After giving interscalene block intravenous dexmedetomidine (1mcg/kg) with dexamethasone (0.15 mg/kg) in 100ml normal saline given over 10 minutes and post-operative analgesia is noted upto 24 hours |
| Comparator Agent |
Intravenous normal saline for post-operative analgesia. |
After giving interscalene block intravenous normal saline 100ml given over 10 minutes and post-operative analgesia is noted upto 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
consenting ASA physical status 1-3 patients scheduled to undergo unilateral ORIF proximal humeral fracture presenting at our hospital will be included in the study. |
|
| ExclusionCriteria |
| Details |
Allergic to study drugs
cogulopathy
infection at the site of block
chronic pain disorder
patient refusal
H/O cardiac,renal or hepatic disease
preexisting neurological deficits of the involved arm
neuropathy affecting the brachial plexus
contraindications to peripheraal nerve block
contralateral paresis of the phrenic or recurrent laryngeal nerves.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| duration of post-operative analgesia(the time from block to rescue analgesic dose) |
upto 24 hrs postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| onset time of block,and 24 hour consumption of rescue analgesic |
upto 24 hrs postoperatively |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
11/01/2025 |
| 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
|
My thesis topic is -The effect of intravenous dexmedetomidine added to dexamethasone in patients undergoing proximal humeral fixation under interscalene block:A double blind randomized placebo controlled trial. It aims to explore the beneficial effects of addition of newer alpha2 agonist to routinely/ conventionally used drugs for regional blocks of upper limb. |