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CTRI Number  CTRI/2021/12/038945 [Registered on: 27/12/2021] Trial Registered Prospectively
Last Modified On: 24/12/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Dexmedetomidine versus Fentanyl in Femoral Nerve Block 
Scientific Title of Study   Dexmedetomidine versus Fentanyl as an Adjunct to Bupivacaine in Femoral Nerve Block: A comparitive Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Parth Shah 
Designation  Associate Professor 
Affiliation  Dr M K Shah Medical college 
Address  Dr M K Shah Medical college and Research centre, SMS multi speciality Hospital, sumandeep vidyapeeth ahmedabad unit

Ahmadabad
GUJARAT
380111
India 
Phone  7567815075  
Fax    
Email  parthshah1291@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Parth Shah 
Designation  Associate Professor 
Affiliation  Dr M K Shah Medical college 
Address  Dr M K Shah Medical college and Research centre, SMS multi speciality Hospital, sumandeep vidyapeeth ahmedabad unit


GUJARAT
380111
India 
Phone  7567815075  
Fax    
Email  parthshah1291@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Parth Shah 
Designation  Associate Professor 
Affiliation  Dr M K Shah Medical college 
Address  Dr M K Shah Medical college and Research centre, SMS multi speciality Hospital, sumandeep vidyapeeth ahmedabad unit


GUJARAT
380111
India 
Phone  7567815075  
Fax    
Email  parthshah1291@gmail.com  
 
Source of Monetary or Material Support  
Dr M K Shah Medical college and Research centre, 
 
Primary Sponsor  
Name  Dr M K Shah Medical college and Research centre SMS multi speciality Hospital  
Address  Dr M K Shah Medical college and Research centre, SMS multi speciality Hospital, sumandeep vidyapeeth ahmedabad unit 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Parth Shah  Dr M K Shah Medical college and Research centre SMS multi speciality Hospital   Dept Of Anaesthesia ,room number 2, main to complex,SMS multi speciality Hospital, sumandeep vidyapeeth ahmedabad unit
Ahmadabad
GUJARAT 		 7567815075

parthshah1291@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  dexmedetomidine and bupivacaine  ): ultrasound guided femoral nerve block before spinal anesthesia will be done for each patient using (18 ml of 0.25% bupivacaine + 0.5 mcg/kg dexmedetomidine diluted in 2 ml saline to reach total volume 20 ml).  
Comparator Agent  fentanyl and bupivacaine  ultrasound guided femoral nerve block before spinal anesthesia will be done for each patient using (18 ml of 0.25% bupivacaine + 1mic/kg fentanyl diluted in 2 ml saline to reach total volume 20 ml). 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients In The Age Range 20-60 Years.
ASA Risk Category I And II.
No Known History Of Allergy, Sensitivity Or Other Form Of Reaction To Local Anesthetics Of The Amide Type.
 
 
ExclusionCriteria 
Details  Patient Refusal.
Patients With Coagulopathy.
Patients On Potent Antiplatelets, Or On Anticoagulants.
Patients With Back & Spine Problems.
Patients With Local Skin Infections At Site Of Injection.
Known Allergy To The Trial Drugs.
Patients With Poor Myocardial Contractility.
Patients With Thoracic Spine Deformity.
ASA III Or More.
 
 
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 
to compare the total duration of analgesia effect of dexmedetomidine and fentanyl as adjuvant to bupivacaine in femoral nerve block for postoperative analgesia .
To calculate total analgesia requirement postoperatively.
 		 Baseline, immediately after block, prior to spinal,5 mins ,30 mins,60 mins, 2 hours and 6 hourly thereafter 
 
Secondary Outcome  
Outcome  TimePoints 
Visual Analogue Scalewill be used for pain measurement  every 30 min post operatively until the first dose of rescue analgesic is given. 
time of rescue analgesia  time at which first dose of analgesia given postoperatively 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   29/12/2021 
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)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Dexmedetomidine versus Fentanyl as an Adjunct to Bupivacaine in Femoral Nerve Block: A comparitive Study

Aims:

We intend to compare the effect of dexmedetomidine and fentanyl as adjuvant to bupivacaine in  femoral nerve block for postoperative analgesia in lower limb surgeries.

 Patients and Methods

All patients will be randomly assigned into two groups (40 patients each).

•        Group BD (No. =40)

·         Group BF (No. =40)

 Once fitness and primary assessment completed patient will be posted for surgery.

After shifting the patient to the induction room, ECG, pulse oximeter, noninvasive blood pressure monitors will be attached. Peripheral venous line will be established and an infusion of lactated ringers’ solution will be started.

Then femoralnerve block will be performed

Technique of ultrasound guided femoral nerve block

In this procedure drug will be given as described below

 Group BD (No. =40): ultrasound guided femoral nerve block before spinal anesthesia will be done for each patient using (18 ml of 0.25% bupivacaine + 0.5 mcg/kg diluted in 2 ml saline to reach total volume 20 ml).

    Group BF (No. =40): ultrasound guided femoral nerve block before spinal anesthesia will be done for each patient using (18 ml of 0.25% bupivacaine + 1mic/kg fentanyl diluted in 2 ml saline to reach total volume 20 ml).

 before femoral nerve block (baseline),

•        after block and before spinal anesthesia,

•        immediately after spinal anesthesia, and

•        every 30 minutes till end of surgery.

 

Ø  Visual Analogue Scalewill be used for pain measurement at regular intervals as primary tool of observation and will be recorded every 30 min post operatively until the first dose of rescue analgesic is given.

 

Visual Analogue Scale:

 
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