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CTRI Number  CTRI/2018/05/013800 [Registered on: 09/05/2018] Trial Registered Retrospectively
Last Modified On:
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of analgesic efficacy of two different modalities of analgesia in patients undergoing knee arthroscopic surgery. 
Scientific Title of Study   Comparative evaluation of analgesic efficacy of adductor canal block versus IV diclofenac in patients undergoing knee arthroscopic surgery. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR R AISHWARYA 
Designation  SENIOR RESIDENT 
Affiliation  VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE , GROUND FLOOR, MAIN OT BUILDING, VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL NEW DELHI INDIA

South
DELHI
110029
India 
Phone  9953413562  
Fax    
Email  ashirocks1989@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR DHARAM SINGH MEENA 
Designation  PROFESSOR 
Affiliation  VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE , GROUND FLOOR, MAIN OT BUILDING, VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL NEW DELHI INDIA
DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE , GROUND FLOOR, MAIN OT BUILDING, VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL NEW DELHI INDIA
South
DELHI
110029
India 
Phone  9910277131  
Fax    
Email  dharams_meena@yahoo.com  
 
Details of Contact Person
Public Query  
Name  DR R AISHWARYA 
Designation  SENIOR RESIDENT 
Affiliation  VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE , GROUND FLOOR, MAIN OT BUILDING, VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL NEW DELHI INDIA

South West
DELHI
110029
India 
Phone  9953413562  
Fax    
Email  ashirocks1989@gmail.com  
 
Source of Monetary or Material Support  
VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL NEW DELHI-110029 INDIA 
 
Primary Sponsor  
Name  VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL  
Address  DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE CARE, GROUND FLOOR, MAIN OT BUILDING, VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL, NEW DELHI- 110029 
Type of Sponsor  Government medical college 
 
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 R AISHWARYA  VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFADARJUNG HOSPITAL, NEW DELHI,-110029, INDIA  DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE , GROUND FLOOR, MAIN OT BUILDING, VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL NEW DELHI INDIA
South
DELHI 		 9953413562

ashirocks1989@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ASA GRADE I AND II PATIENTS AGED 18-65 YEARS, UNDERGOING ELECTIVE UNILATERAL KNEE ARTHROSCOPIC SURGERY.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ADDUCTOR CANAL BLOCK  IN THIS GROUP PATIENTS WILL BE GIVEN GENERAL ANAESTHESIA WITH INJECTION FENTANYL 2mcg/Kg,INJECTION PROPFOL 2mg/Kg, INJECTION VECURONIUM 0.1mg/KgAND AIRWAY WILL BE SECURED WITH PROSEAL LMA. ALL PATIENTS WILL BE MECHANICALLY VENTILATED AND ANAESTHESIA WILL BE MAINTAINED WITH OXYGEN, NITROUS OXIDE AND ISOFLURANE. BEFORE REVERSAL OF NEUROMUSCULAR BLOCK PATIENTS WILL BE GIVEN SINGLE SHOT USG GUIDED ADDUCTOR CANAL BLOCK WITH 30ml OF 0.5% ROPIVACAINE. 
Comparator Agent  DICLOFENAC  IN THIS GROUP PATIENTS WILL BE GIVEN GENERAL ANAESTHESIA WITH INJECTION FENTANYL 2mcg/Kg,INJECTION PROPFOL 2mg/Kg, INJECTION VECURONIUM 0.1mg/KgAND AIRWAY WILL BE SECURED WITH PROSEAL LMA. ALL PATIENTS WILL BE MECHANICALLY VENTILATED AND ANAESTHESIA WILL BE MAINTAINED WITH OXYGEN, NITROUS OXIDE AND ISOFLURANE.BEFORE REVERSAL OF NEUROMUSCULAR BLOCK PATIENTS WILL BE GIVEN INJECTION DICLOFENAC 1mg/Kg AND THEN 8 HOURLY.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA I AND ASA II.
PATIENTS SCHEDULED TO UNDERGO ELECTIVE UNILATERAL ARTHROSCOPIC SURGERY. 
 
ExclusionCriteria 
Details  HISTORY OF ALLERGY TO LOCAL ANAESTHETIC
HISTORY OF COAGULOPATHY
PREVIOUS NEUROLOGICAL DEFICIT
HISTORY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE, HEPATOBILIARY DISEASE, RENAL DISEASE AND CARDIOVASCULAR DISEASE
MENTAL DEFICIT THAT HINDERS THE COMPREHENSION OF SCALE OF PAIN USED IN THIS STUDY
BMI>35 (TECHNICAL DIFFICULTY)
CUTANEOUS INFECTION AT THE SITE OF BLOCK 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
TO COMPARE THE ANALGESIC EFFICACY OF SINGLE SHOT ADDUCTOR CANALBLOCK VERSUS IV DICLOFENAC IN PATIENTS UNDERGOING KNEE ARTHROSCOPIC SURGERY  3O MINUTES, 2 HOURS - AT REST
30 MINUTES, 2 HOURS, 6 HOURS , 12 HOURS , 24 HOURS- AT REST, ON STANDING,ON WALKING 3 METERS  
 
Secondary Outcome  
Outcome  TimePoints 
TO ASSESS THE REQUIREMENT OF RESCUE ANALGESIA IN BOTH THE GROUPS  30 MINUTES, 2 HOURS, 6 HOURS, 12 HOURS , 24 HOURS 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/12/2014 
Date of Study Completion (India) 03/02/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="2"
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 STUDY WAS CONDUCTED TO COMPARE THE ANALGESIC EFFICACY OF SINGLE SHOT ADDUCTOR CANAL BLOCK VERSUS IV DICLOFENAC IN PATIENTS UNDERGOING ELECTIVE UNILATERAL ARTHROSCOPIC KNEE SURGERY UNDER GENERAL ANAESTHESIA.  60 ASA I/II PATIENTS ,AGED 18-65 YEARS WERE RANDOMIZED TO RECEIVE EITHER SINGLE SHOT USG GUIDED ADDUCTOR CANAL BLOCK WITH 30 ml OF 0.5% ROPIVACAINE BEFORE REVERSAL OF ANAESTHESIA OR INTRAVENOUS DICLOFENAC 1mg/Kg AT THE TIME OF COMPLETION OF SURGERY, AND THEN 8 HOURLY.  VAS WAS ASSESSED AT 30 MINUTES, 2 HOURS AT REST AND 6, 12, 24 HOURS AT REST, ON STANDING AND ON WALKING 3 METERS. THE MEAN VAS SCORES WERE SIGNIFICANTLY LOWER IN THE ADDUCTOR CANAL BLOCK WHICH WERE STATISTICALLY SIGNIFICANT. THE MEAN DURATION OF ANALGESIA IN THE BLOCK GROUP DEFINED AS THE TIME ELAPSED BETWEEN THE REGIONAL NERVE BLOCK AND THE FIRST RESCUE ANALGESIC WAS HIGHER 18.6 HOURS AS COMPARED TO 10.13 HOURS IN THE DICLOFENAC GROUP. THIS DIFFERENCE WAS STATISTICALLY SIGNIFICANT WITH A P VALUE OF <0.0005. NO SIGNIFICANT POST OPERATIVE COMPLICATIONS OR LOCAL SIDE EFFECTS RELATED TO THE BLOCK WERE  NOTED. THUS ADDUCTOR CANAL BLOCK PROVIDES EFFECTIVE AND ADEQUATE ANALGESIA FOR POST OPERATIVE PAIN RELIEF IN PATIENTS UNDERGOING ARTHROSCOPIC KNEE SURGERY. 
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