| CTRI Number |
CTRI/2024/03/064351 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two injection above collar bone for nerve block in named 0.5%plaine levobupivacaine with dexmedetomidine and 0.5% plain levobupivacaine with dexamethasone in patients undergoing upper limb surgeries. |
|
Scientific Title of Study
|
Dexmedetomidine versus dexamethasone as adjuvants to 0.5% Levobupivacaine in ultrasound guided supraclavicular brachial plexus block |
| 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 Niketa Jain |
| Designation |
Junior Resident (MD Anaesthesia) |
| Affiliation |
Teerthanker Mahaveer medical college and research centre ,Moradabad |
| Address |
Room no.204 ,2nd floor ,Department of Anaesthesia,Teerthanker Mahaveer medical college and research centre,Moradabad ,Uttar Pradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7651982145 |
| Fax |
|
| Email |
niketajain21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Md Shahbaz Alam |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer medical college and research centre Moradabad |
| Address |
Room no.204 ,2nd floor Department of Anaesthesia, Teerthanker Mahaveer medical college and research centre Moradabad,UttarPradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9897907372 |
| Fax |
|
| Email |
dralamshahbaz006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Niketa Jain |
| Designation |
Junior Resident |
| Affiliation |
Teerthanker Mahaveer medical college and research centre Moradabad |
| Address |
Room no.204,2nd floor Department of Anaesthesia,Teerthanker Mahaveer medical college and research centre Moradabad UttarPradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7651982145 |
| Fax |
|
| Email |
niketajain21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Teerthanker Mahaveer medical college UttarPradesh |
|
|
Primary Sponsor
|
| Name |
Teerthanker Mahaveer medical college Moradabad |
| Address |
Teerthanker Mahaveer medical college Moradabad UttarPradesh |
| 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 |
| Dr Niketa Jain |
Teerthanker Mahaveer medical college Moradabad UttarPradesh |
Department of Anaesthesia,Teerthanker Mahaveer medical College Moradabad UttarPradesh
Moradabad
UTTAR PRADESH |
7651982145
niketajain21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee T.M. university Moradabad UttarPradesh |
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 |
0.5% Levobupivacaine 30 ml containing with Dexamethasone 0.1 mg/kg |
Under all aseptic precaution Supraclavicular brachial block performed .
onset and duration of sensory and motor block assessed. |
| Comparator Agent |
0.5% Levobupivacaine 30 ml containing with Dexmedetomidine 1mcg/kg |
Supraclavicular brachial block performed and onset of sensory and motor block every 2min till 30 minutes .
Duration are return of complete sensory block and complete motor function |
| Intervention |
0.5% Plain Levobupivacaine (25 ml)+5ml Normal saline
|
Under all aseptic precaution Supraclavicular brachial plexus block performed using ultrasound machine and drug inject arround brachial plexus cluster
Complete sensory block and motor block achieved
Onset of sensory and motor block will be assessed every 2min till 30 minute
Duration of intervention till 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Upper limb surgeries
Written and informed consent
ASA Physical status 1 and 2 |
|
| ExclusionCriteria |
| Details |
Bleeding diathesis
Hypersensitivity to local anaesthesia
Neuromuscular disorders and significant systemic disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Each participant in the study will be assessed for following primary outcome parameters are as follows:-
To compare the onset of sensory and motor block
To compare the duration of sensory and motor block. |
Onset of sensory and motor block will be assessed every 2minute till 30 minute.
Time period from the end of LA administration to complete resolution of sensory block and return to complete motor function will be taken duration of sensory and motor block. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Each participant in the study will be assessed for following secondary outcome parameters are as:-
To compare the duration of first rescue analgesia.
To compare the total analgesic consumption in 24hour post operatively.
To compare the hemp dynamic parameters. |
Post operatively pain will be assessed every 30 minute for first 2 hours till 12hours then 4 hourly till 24 hours.
|
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
26/03/2024 |
| 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="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
|
Different adjuvants are used with levobupivacaine for supraclavicular block which decrease the onset time and enhanced the duration of the sensory ,motor blockade and duration of analgesia with minimal systemic side effects. As limited literature is available for comparison .so this study compares levobupivacaine and combination of levobupivacaine with dexmedetomidine versus dexamethasone as adjuvants in ultrasound guided supraclavicular brachial plexus block. |