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CTRI Number  CTRI/2017/08/009521 [Registered on: 28/08/2017] Trial Registered Retrospectively
Last Modified On: 24/08/2017
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 pain relief with clonidine, dexamethasone and dexmedetomidine as an adjuvant to local anesthetics in Femoral nerve block - which works better? 
Scientific Title of Study   Comparison of Clonidine vs Dexmedetomidine vs Dexamethasone as an adjuvant to local anesthetic for Femoral nerve block in patient for elective anterior cruciate ligament reconstruction surgery  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sumit Vaghani 
Designation  MBBS DNB Anaesthesia Diploma in Anaesthesia 
Affiliation  Ganga Medical Center and Hospital 
Address  Ganga Medical Center and Hospital, Department of anesthesiology, 5th floor, Operation theater complex, 313 Mettupalayam Road Opposite Saibaba koil

Coimbatore
TAMIL NADU
641043
India 
Phone  9558000952  
Fax    
Email  sumitvaghani277@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sumit Vaghani 
Designation  MBBS DNB Anaesthesia Diploma in Anaesthesia 
Affiliation  Ganga Medical Center and Hospital 
Address  Ganga Medical Center and Hospital, Department of anesthesiology, 5th floor, Operation theater complex, 313 Mettupalayam Road Opposite Saibaba koil

Coimbatore
TAMIL NADU
641043
India 
Phone  9558000952  
Fax    
Email  sumitvaghani277@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr J Balavenkatsubramanian 
Designation  Senior Consultant Anesthesiology 
Affiliation  Ganga Medical Center and Hospital 
Address  Ganga Medical Center and Hospital, Department of anesthesiology, 5th floor, Operation theater complex, 313 Mettupalayam Road Opposite Saibaba koil

Coimbatore
TAMIL NADU
641043
India 
Phone    
Fax    
Email  drbalavenkat@gmail.com  
 
Source of Monetary or Material Support  
Ganga Medical Centre and Hospital, Coimbatore 
 
Primary Sponsor  
Name  Ganga Medical Centre and Hospital 
Address  313 Mettupalayam Road Opposite Saibaba koil Coimbatore 641043 Tamilnadu India 
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 
Sumit Vaghani  Ganga Hospital, Coimbatore   Department of orthopaedic and trauma, 5th floor operation theatre complex
Coimbatore
TAMIL NADU 
9558000952

sumitvaghani277@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patient having anterior cruciate ligament injury,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Clonidine  Femoral nerve block is performed using 30 ml of 0.25% bupivacaine with 1 mcg/kg of clonidine under combined ultrasonography and peripheral nerve stimulation guidance 
Comparator Agent  Dexamethasone  Femoral nerve block is performed using 30 ml of 0.25% bupivacaine with 8 mg of dexamethasone under combined ultrasonography and peripheral nerve stimulation guidance 
Comparator Agent  Dexmedetomidine  Femoral nerve block is performed using 30 ml of 0.25% bupivacaine with 1 mcg/kg of Dexmedetomidine under combined ultrasonography and peripheral nerve stimulation guidance 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) All patients of ASA physical status I and II
2) Patient posted for elective surgical procedure 
 
ExclusionCriteria 
Details  1) Patient less than 18 year and more than 65 year
2) Pregnant and lactating women
3) Hemodynamically compromised patient
4) Non consenting patient/relatives refusal for procedure
5) Surgery on emergency patients with associated uncontrolled systemic disease
6) Patients in ASA physical status III and IV
7) Allergic to Medication
8) Bleeding diathesis  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
VAS score less than 3 (Duration of Analgesia)  48 Hours 
 
Secondary Outcome  
Outcome  TimePoints 
Onset and Duration of Sensory blockade, Rescue Analgesia  48 Hours 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2013 
Date of Study Completion (India) 18/12/2013 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

A prospective randomized double blind controlled trial including 90 ASA I & II patients between age 18 – 65 yrs for elective arthroscopic anterior cruciate ligament reconstruction surgery divided into 3 groups Group A Clonidine plus Bupivacaine, Group B Dexmedetomidine plus Bupivacaine and Group C Dexamethasone and Bupivacaine. The study compares the effects of clonidine, dexmedetomidine and dexamethasone as an adjuvant to bupivacaine in arthroscopic anterior cruciate ligament reconstruction surgeries in postoperative period for 24 hrs after ultrasound and peripheral nerve stimulation guided femoral nerve block and thus concluding which drug combination produces better analgesia with minimal haemodynamic alterations. 

 

Finding summary: Addition of Dexamethasone to local anesthetic drugs in femoral block significantly prolongs the onset and duration of analgesia, sensory and motor block as compared to clonidine and dexmedetomidine in patients undergoing ACL reconstruction surgeries. Dexamethasone as an additive provides: Better pain relief, prolongation of post operative analgesia and, decrease consumption of systemic analgesics in post operative period with manageable hemodynamic alterations. It is a remarkably, safe and cost effective method of providing postoperative analgesia. US-guided brachial plexus block technique has several advantages including faster onset and greater block success.

 
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