| CTRI Number |
CTRI/2025/08/092384 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
We make a two group of patient of upper limb injury and comparasion between Dexmedetomidine and Dexamethasone as Adjuvants in local
Supraclavicular Brachial Plexus Block in orthopaedic surgery observed which is better analgesia and hero dyne mic stable |
|
Scientific Title of Study
|
Comparative Evaluation of Dexmedetomidine and Dexamethasone as Adjuvants in
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 |
Paresh M Chaudhary |
| Designation |
Resident Doctor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department , General Ot Complex, 2nd Floor, Dhiraj Hospital , Smt. BKShah Medical Institute and Research Centre , Wagodhia , Pipariya, Vadodara at-piparia,waghodiya
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9512305508 |
| Fax |
|
| Email |
chaudharyparesh2016@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilesh Shah |
| Designation |
Professor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department , General Ot Complex, 2nd Floor, Dhiraj Hospital , Smt. BKShah Medical Institute and Research Centre , Wagodhia , Pipariya, Vadodara at-piparia,waghodiya
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9512305508 |
| Fax |
|
| Email |
nileshshah730@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nilesh Shah |
| Designation |
Professor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department , General Ot Complex, 2nd Floor, Dhiraj Hospital , Smt. BKShah Medical Institute and Research Centre , Wagodhia , Pipariya, Vadodara at-piparia,waghodiya
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9512305508 |
| Fax |
|
| Email |
nileshshah730@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department , General Ot Complex, 2nd Floor, Dhiraj Hospital , Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre , Wagodhia , Pipariya, Vadodara Wagodhia , Pipariya, Vadodara Vadodara GUJARAT 391760 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Paresh Chaudhary |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
Anaesthesia Department , General Ot Complex, 2nd Floor, Dhiraj Hospital , Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre , Wagodhia , Pipariya, Vadodara Wagodhia , Pipariya, Vadodara
Vadodara
GUJARAT |
9512305508
chaudharyparesh2016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SUMANDEEP VIDYAPEETH INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S599||Unspecified injury of elbow and forearm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexamethasone as an adjuvant in supraclavicular brachial plexus block |
The study compares efficacy of both adjuvant in supraclavicualr brachial plexus block dose of dexomethasone is eight mg mixed with bupivacaine duration of analgesia first hour every fifteen minutes and than one hourly and peri operative hemodynamic changes till twenty four hours after surgery |
| Intervention |
Dexmedetomidine as an adjuvant in supraclavicular brachial plexus block |
Evaluate outcomes such as onset and duration of sensory and motor block duration of analgesia first hour every fifteen minutes and than one hourly and peri operative hemodynamic changes till twenty four hours after surgery dose 0.5mcg per Kg weight |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing to sign inform consent.ASA grade I and II patients posted for elective upper limb surgeries |
|
| ExclusionCriteria |
| Details |
Patient refusal
Infection at local site
Hypersensitivity or Allergy to local anaesthetic agent
Coagulation disorders
Patient on Anticoagulants
Alcoholic or patient with drug abuse
Patients receiving any drug that interact with our study drug
Pre Existing Nerve injury
Inadequate effect of nerve block or supplemented with other type of anaesthesia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This prospective and observational study will help us to compare the efficacy between Inj. Bupivacaine and Inj dexomethasone vs Inj Bupivacaine and Inj dexmedetomidine Improving the duration and Quality of analgesia, Reducing dose of bupivacaine so reduce toxicity, some provide sedation |
This prospective and observational study will help us to compare the efficacy between inj Bupivacaine and Inj dexomethasone vs Inj Bupivacaine and Inj dexmedetomidine Improving the duration and Quality of analgesia, Reducing dose of bupivacaine so reduce toxicity, some provide sedation haemodynamic responses to anaesthesia by having better outcome in haemodynemics at baseline and fifteen minutes after inductuin up to one hour and than one hourly up to twenty four hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Analgesia & haemodynamic responses to anaesthesia by having better outcome in haemodynemic |
Twenty four hours after induction of local anaesthesia after surgery |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
28/08/2025 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Other (Terminated) |
| 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
|
Subject: “Comparative Evaluation of Dexmedetomidine and Dexamethasone as Adjuvants in Supraclavicular Brachial Plexus Block”
AIM: To Comparative Evaluation of Dexmedetomidine and Dexamethasone as Adjuvants in Supraclavicular Brachial Plexus Block” OBJECTIVES 1.To observe and compare Onset and duration of sensory and motor block 2.To observe and compare Duration of analgesia 3.To compare Perioperative hemodynamic changes & any adverse effects
MATERIAL AND METHODOLOGY This will be a comparative double blinded randomized observational study in which after approval from institutional review board and informed written consent from the patient, study will be started. All patients will be subjected to detailed pre anaesthetic evaluation with clinical history, general and systemic examination and all routine investigations like hemoglobin, RBS, RFT, LFT, serum electrolytes, X-ray, ECG and other specific investigations according to the patient’s clinical evaluation. Patients will be advised to keep NBM before Operation. Pre-Operative vitals will be recorded. An IV infusion of Ringer Lactate /Normal Saline will be started.
Study Design- randomized double blinded Study
Study Duration- The study will be initiated after obtaining the permission from institutional ethics committee till the achievement of the sample size or by whichever is earlier.
Sample size:60s,2 group each divided in 30s Group-1 :Patients who have received inj. Bupivacaine 0.5% 20 ml with inj. Dexmedetomidine 0.5 mcg/kg through PNS or USG machine guided supraclavicular block Group-2: patients who have received inj. Bupivacaine 0.5% 20 ml with inj. dexomethasone (8mg) through PNS or USG machine guided supraclavicular block.
OBSERVATIONS :
1. OnsetofSensoryBlock 2. DurationofSensoryBlock 3. OnsetofMotorBlock 4. DurationofMotorBlock 5. DurationofAnalgesia:TimefromOnsetofsensoryblocktoneedforfirstrescueanalgesia. 6. Hemodynamic Parameters 7. SedationScore 8. PerioperativeComplications |