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CTRI Number  CTRI/2018/10/016113 [Registered on: 23/10/2018] Trial Registered Retrospectively
Last Modified On: 13/08/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   comparison of Pain relief after total knee replacement surgery between adductor canal block and local intraarticular infiltration 
Scientific Title of Study   Postoperative pain relief in Total Knee Arthroplasty: Ultrasound-guided Adductor Canal Block vs Local Intraarticular Infiltration, A Randomised, Prospective, Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Magesh  
Designation  junior resident  
Affiliation  AIIMS 
Address  Department of anesthesiology pain medicine and critical care All India Institute of Medical Sciences New delhi

South
DELHI
110029
India 
Phone  9013078163  
Fax    
Email  magesh.268@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dilip RShende 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of anesthesiology pain medicine and critical care All India Institute of Medical Sciences New delhi

South
DELHI
110029
India 
Phone  8800377697  
Fax    
Email  dilipshende@gmail.com  
 
Details of Contact Person
Public Query  
Name  Magesh  
Designation  junior resident  
Affiliation  All India Institute of Medical Sciences 
Address  Department of anesthesiology pain medicine and critical care All India Institute of Medical Sciences New delhi

South
DELHI
110029
India 
Phone  9013078163  
Fax    
Email  magesh.268@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences New delhi 110029 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  ansari nagar New delhi 
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 
DrMagesh  AIIMS New delhi  AB1 first floor All India Institute of Medical Sciences
South
DELHI 		 9013078163

magesh.268@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics sub-committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A  A single-shot adductor canal block , using a 21G needle a solution of {30ml 0.25% ropivacaine + 2µg/kg clonidine} will be given at the mid-thigh level using a high frequency linear ultrasound transducer, as described by Manickam et al 
Intervention  Group B  Local intra-articular infiltration will be injected by the surgeon with a solution of {30ml 0.25% ropivacaine + 2µg/kg clonidine} into the quadriceps muscles, hamstrings at the adjoining distal end, capsule, medial-collateral ligament, lateral collateral ligament and sub-cutaneous tissues. 
Comparator Agent  Group C  No intervention will be done. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  ASA physical status I-III scheduled for elective primary unilateral knee arthroplasty  
 
ExclusionCriteria 
Details  1.Age > 80 years
2.ASA IV / V
3.Bilateral / Revision TKA
4.Morbid obesity (BMI ≥ 40 )
5.History of focal neurological deficit
6.History of sensory or motor disorders of limb to be operated
7.History of allergy to local anaesthetics , clonidine
8.History of regular opioid use
9.Local site infection
10.Patient refusal to partake in the study.
11.Contraindication to spinal anaesthesia
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To estimate the total morphine consumption in the three groups   24 hours postopertively 
 
Secondary Outcome  
Outcome  TimePoints 
To assess pain scores at rest and movement using visual analogue scale  0,4,8,12,24 hours postoperatively 
To estimate the time to first use of patient controlled analgesia device  24 hours postoperatively 
To compare the side effects associated with morphine consumption in the three groups  24 hours postoperatively 
To estimate the worst pain during and time taken to perform the timed get up and go (TUG) test  24 hours postoperatively 
To assess patient satisfaction  24 hours postoperatively 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/03/2016 
Date of Study Completion (India) 12/09/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
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  

In conclusion, in patients undergoing elective unilateral total knee arthroplasty(TKA), adductor canal block(ACB) was found to be superior to both local intraarticular infiltration and control group in reducing the 24 hour morphine consumption, lowering VAS scores at rest and with movement, prolonging time to first analgesia, reducing requirement of rescue analgesia, lowering worst VAS score during timed up and go test(TUG test) and showing better patient satisfaction scores. The incidence of opioid-related side-effects was comparable among the three groups. Adductor canal block also was not associated with any complications related to its technique, hence ACB can be considered a safe technique to be used in patients undergoing unilateral TKA for postoperative analgesia. While local intra-articular infiltration was found to be superior to control group in reducing 24 hour PCA morphine consumption, lowering VAS scores both at rest and with movement, prolonging time to first analgesia, reducing the requirement of rescue analgesia and showing better patient satisfaction compared to control group.

 
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