| CTRI Number |
CTRI/2024/01/061745 [Registered on: 23/01/2024] Trial Registered Prospectively |
| Last Modified On: |
17/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparing efficacy of dexmedetomidine as an add on drug to levobupivacaine when injected near a nerve versus when dexmedetomidine given intravenous and levobupivacaine given near nerve in ultrasound guided Supraclavicular Brachial Plexus Block in Upper Limb Surgeries |
|
Scientific Title of Study
|
Comparing Efficacy Of Perineural Versus Intravenous Dexmedetomidine as an Adjuvant
to 0.5 % Levobupivacaine in ultrasound guided Supraclavicular Brachial Plexus Block in Upper Limb Surgeries in Department of Anaesthesia at SMS Hospital ,Jaipur |
| 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 Poonam Kalra |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Anesthesia, second floor, Dhanvantri complex, SMS
Hospital, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India
Jaipur
RAJASTHAN
302004
India |
| Phone |
9413416787 |
| Fax |
|
| Email |
poonamkalra24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Kalra |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Anesthesia, second floor, Dhanvantri complex, SMS
Hospital, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India
Jaipur
RAJASTHAN
302004
India |
| Phone |
9413416787 |
| Fax |
|
| Email |
poonamkalra24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Santosh Kanwar |
| Designation |
Junior Resident |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Anesthesia, second floor, Dhanvantri complex, SMS
Hospital, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India
Jaipur
RAJASTHAN
302004
India |
| Phone |
9166957444 |
| Fax |
|
| Email |
santoshrajvi50@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia,second floor,Dhanwantri Complex,
Sawai Man Singh Medical College and Hospital
|
|
|
Primary Sponsor
|
| Name |
Sawai Man Singh Medical College and Hospital |
| Address |
Department of Anesthesia, second floor, Dhanvantri complex, SMS
Hospital, Jaipur, Rajasthan
|
| 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 Poonam Kalra |
Sawai Man Singh Medical College and Hospital |
Department of
Anesthesia, second
floor, Dhanvantri
complex, SMS Hospital,
Jaipur, Rajasthan
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN |
9413416787
poonamkalra24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of ethics committee, SMS Medical college and attached hospitals, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Upper Limb Surgeries |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
dexmedetomidine is given intravenously |
patients will receive 0.5% Levobupivacaine for ultrasound guided supraclavicular brachial plexus block along with dexmedetomidine in 50 mL of normal saline administered as infusion over 10 minutes |
| Intervention |
Perineural dexmedetomidine with 0.5% levobupivacaine |
patients will receive 25 ml 0.5% Levobupivacaine and 1mcg/kg Dexmedetomidine diluted in 2ml NS for ultrasound guided supraclavicular brachial plexus block.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
Patients who Will give informed written consent
Either sex
American Society of Anesthesiologists Physical Status (ASA-PS) Classes I and II
Posted for upper limb surgeries
Body weight :– 40-70 kg |
|
| ExclusionCriteria |
| Details |
Patients having severe systemic illness and bleeding disorders,
Pregnant women
Patients allergic to study drugs
Patients having peripheral neuropathy or motor neuron disorders
Patients having pathology at infection site Disability limiting the preferences of block |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess and compare the difference in mean duration of analgesia in both
the groups. |
0,5,10,15,20,25,30,45,60,75,90 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Onset of sensory block (minutes)
Onset of motor block (minutes)
Duration of motor block (minutes)
Mean systolic B.P, Mean diastolic B.P, Mean of mean B.P
Mean heart rate
Proportion of adverse effects if any in both the groups. |
0,5,10,15,20,25,30,45,60,75,90 minutes |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 |
|
Date of First Enrollment (India)
|
26/01/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
In this study we plan to study and draw comparison of effect of dexmedetomidine when given near nerves versus when given intravenous.
The study will be conducted in following two groups of patients. Study
will consist of 100 patients. GROUP A 50 patients will receive Perineural 25ml 0.5% Levobupivacaine plus 1mcg/kg Dexmedetomidine diluted in 2ml
NS for ultrasound guided supraclavicular brachial plexus block. along with IV 50 ml Normal saline administered as infusion over 10 minutes. GROUP B 50 patients will receive Perineural: 25ml 0.5% Levobupivacaine plus 2ml NS for ultrasound guided supraclavicular
brachial plexus block IV 1 μg/kg-1 dexmedetomidine in 50 mL of normal saline administered as infusion over
10 minutes |