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CTRI Number  CTRI/2019/10/021787 [Registered on: 24/10/2019] Trial Registered Prospectively
Last Modified On: 23/10/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   We are going to inject the drug in the front side of middle of thigh in patients who are undergoing below knee bone surgeries with the help of ultrasound machine and want to study how effective it works for controlling pain. 
Scientific Title of Study   Effectiveness Of Ultrasound guided Adductor canal block for post operative pain management in below Knee Orthopedics surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Elakuchi Vikas Rao 
Designation  PG resident  
Affiliation  Kalinga institute of medical sciences 
Address  Pg residents hostel (male) Above Coca-Cola central canteen Kalinga institute of medical sciences kiit road Bhubaneshwar Odisha

Khordha
ORISSA
751024
India 
Phone  8985330820  
Fax    
Email  vikas.kmc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Lingaraj Sahu 
Designation  Associate professor 
Affiliation  Kalinga institute of medical sciences 
Address  Department of Anaesthesia Main OT complex Pradyumna Bal Memorial Hospital kims Bhubaneshwar Odisha

Khordha
ORISSA
751024
India 
Phone  8280166501  
Fax    
Email  drlingarajsahu.2008@gmail.com  
 
Details of Contact Person
Public Query  
Name  Lingaraj Sahu 
Designation  Associate professor 
Affiliation  Kalinga institute of medical sciences 
Address  Department of Anaesthesia Main OT complex Pradyumna Bal Memorial Hospital kims Bhubaneshwar Odisha

Khordha
ORISSA
751024
India 
Phone  8280166501  
Fax    
Email  drlingarajsahu.2008@gmail.com  
 
Source of Monetary or Material Support  
Elakuchi Vikas Rao Door no 2 ,doctors residential hostel(male) above coca cola central canteen campus 5 kims hospital patia bhubaneshwar 751024 
 
Primary Sponsor  
Name  Elakuchi Vikas Rao 
Address  Door no 2 Doctors residential hostel(male) Above Coca cola central canteen Campus 5 KIMS hospital Patia Bhubaneshwar 751024 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
kalinga institute of medical sciences  kiit road chandaka industrial estate bhubaneshwar odisha 751024 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Elakuchi Vikas Rao  Pradyumna Bal Memorial Hospital  Kalinga Institute of Medical Sciences Kiit road Chandaka industrial estate Bhubaneshwar Odisha 751024
Khordha
ORISSA 		 8985330820

vikas.kmc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S822||Fracture of shaft of tibia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ADDUCTOR CANAL BLOCK  Group ‘A’ patients will be given ultra sound guided adductor canal block (ACB) at the end of surgery before shifting to post-operative ward 
Comparator Agent  Standard medical regimen according to anaesthesia protocol  Group B patients will be given intravenous analgesics and Adductor canal block will not given  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Willing patients operated under spinal anaesthesia.
2.American society of anaesthesiologists (ASA) physical status I and II.
3.Either sex (male/female).
Below knee orthopaedic surgeries. 
 
ExclusionCriteria 
Details  1.Patient refusal.
2.History of allergy to the drugs which will be used in the study.
3.Patient enrolled in other studies.
4.Patients with psychiatric disorders.
5.High risk for development of compartmental syndrome.
6.At risk of nerve injury. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Post- operative VAS(visual analogue Score) and rescue analgesic requirement  After the end of surgery till first 24 hours  
 
Secondary Outcome  
Outcome  TimePoints 
Patients feedback on post-operative pain control  After the end of the surgery till first 24 hours 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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)   01/11/2019 
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="2"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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)?  

Brief Summary   we are going to study the effectiveness of  adductor canal block in the patients who are undergoing below knee orthopaedics surgeries .we will randomly divide patients in to two groups (A &B) by computer generated randomization list . for group A patients ultrasound guided adductor canal block will be given at the end of surgery with 40ml of  0.125% bupivacaine around the sephanous nerve in the middle third of thigh. for group B patients intravenous analgesics will be given post-operatively . for both the groups injection paracetamol 1gm will be given  post-operatively. pain in the post-operative period will be compared by using VAS (visual analogue score) on a scale of 0-10. if score is more than 3 ,as a rescue analgesic tramadol 1mg/kg body wt will be given. After that  VAS will be assessed every 10 minutes and if VAS remains >3 ,an inccremental dose of 0.25mg/kg of tramadol will be given till VAS becomes <3 .The first analgesic demand and total requirement of tramadol in the first 24 hrs will be calculated and compared between both the groups.  
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