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CTRI Number  CTRI/2020/03/024180 [Registered on: 23/03/2020] Trial Registered Prospectively
Last Modified On: 29/05/2024
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   To study effect of adductor canal infiltration given by operating surgeon on pain management and recovery in patients undergoing total knee replacement.  
Scientific Title of Study   Effect of surgeon administered adductor canal infiltration through operative exposure as an adjuvant to periarticular infiltration in pain management and early functional recovery after total knee arthroplasty (TKA) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajesh Maniar 
Designation  Head Of Department, Department of Orthopaedics 
Affiliation  Lilavati hospital and Research Centre, 
Address  A-791, Bandra Reclamation, Bandra (W), Mumbai, India.Pin-400050

Mumbai (Suburban)
MAHARASHTRA
400050
India 
Phone    
Fax    
Email  drmaniar@jointspeciality.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajesh Maniar 
Designation  Head Of Department, Department of Orthopaedics 
Affiliation  Lilavati hospital and Research Centre, 
Address  A-791, Bandra Reclamation, Bandra (W), Mumbai, India.Pin-400050

Mumbai (Suburban)
MAHARASHTRA
400050
India 
Phone    
Fax    
Email  drmaniar@jointspeciality.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajesh Maniar 
Designation  Head Of Department, Department of Orthopaedics 
Affiliation  Lilavati hospital and Research Centre, 
Address  A-791, Bandra Reclamation, Bandra (W), Mumbai, India.Pin-400050

Mumbai (Suburban)
MAHARASHTRA
400050
India 
Phone    
Fax    
Email  drmaniar@jointspeciality.com  
 
Source of Monetary or Material Support  
Lilavati hospital and Research Centre, A-791, Bandra Reclamation, Bandra (W), Mumbai, India.Pin-400050  
 
Primary Sponsor  
Name  Dr Rajesh Maniar 
Address  Lilavati hospital and Research Centre, A-791, Bandra Reclamation, Bandra (W), Mumbai, India.Pin-400050  
Type of Sponsor  Other [Self] 
 
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 Rajesh Maniar  Lilavati hospital and Research Centre,  A-791, Bandra Reclamation, Bandra (W), Mumbai, India.Pin-400050
Mumbai (Suburban)
MAHARASHTRA 
9821422246

drmaniar@jointspeciality.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Lilavati Hospital and Research Centre: Ethics Committee for Biomedical & Health Research (EC-BHR)  Approved 
Lilavati Hospital and Research Centre: Ethics Committee for Biomedical and Health Research (EC-BHR)  Approved 
Lilavati Hospital and Research Centre: Ethics Committee for Biomedical and Health Research (EC-BHR)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Surgeon administered adductor canal infiltration and periarticular infiltration from primary exposure of joint.  Current practice is to give periarticular infiltration from the primary exposure for pain relief. This will form our control group. In the study group we will give an additional surgeon administered adductor canal infiltration from the primary exposure of joint. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  i) Unilateral total knee replacement
ii) Primary total knee replacement
iii) Spinal anesthesia only
iv) Willing to participate in study and sign consent form
 
 
ExclusionCriteria 
Details  i) Bilateral Total Knee Replacement
ii) Revision Total Knee Replacement
iii) Medical conditions (eg : chronic kidney disease) requiring alteration in pain management protocol
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1)Pain by Visual Analogue scale
2) Analgesic consumption (PCA consumption) 
1) Preoperatively,
6 hours Postoperatively
Postoperative Day 1,
Postoperative Day 2,
Postoperative Day 3
2) 6 Hours postoperatively
Postoperative Day 1,
Postoperative Day 2,
 
 
Secondary Outcome  
Outcome  TimePoints 
1) Flexion
2) TUG test
3) Time to meet discharge in hours 
1) Preoperatively,
Post operative Day 1,
Post operative Day 2,
Postoperative Day 3,
Post operative Day 14
2) Preoperatively,
Post operative Day 1,
Post operative Day 2,
Postoperative Day 3,
Post operative Day 14
 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/03/2020 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
1. Pepper AM, North TW, Sunderland AM, Davis JJ. Intraoperative Adductor Canal Block for Augmentation of Periarticular Injection in Total Knee Arthroplasty: A Cadaveric Study. J Arthroplasty. 2016 Sep;31(9):2072-6.14. 2) Koh IJ, Choi YJ, Kim MS, Koh HJ, Kang MS, In Y. Femoral Nerve Block versus Adductor Canal Block for Analgesia after Total Knee Arthroplasty. Knee Surg Relat Res. 2017 Jun 1;29(2):87-95. 3) 17. Max Greenky et al, Intraoperative Surgeon Administered Adductor Canal Blockade is not Inferior to Anesthesiologist Administered Adductor Canal Blockade:A Prospective Randomized Trial. J Arthroplasty. 2020 Feb; https://doi.org/10.1016/j.arth.2020.02.011  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Pain management post Total Knee Arthroplasty (TKA) has improved significantly over the last decade with the current practice involving a multimodal strategy. One of the most important issues concerning patients is immediate postoperative pain. Post TKA , upto 60 % patients have severe knee pain and 30% have moderate knee pain. Effective pain management using a multimodal approach promises to decrease complications, improve outcomes, and increase patient satisfaction after hip and knee arthroplasty. Current strategies involve using peripheral nerve blockade, periarticular injections, and multimodal oral opioid and nonopioid medications during the perioperative and postoperative periods to provide superior pain control.

Local periarticular infiltration of analgesic agents has been found to effectively control pain and improve functional outcome. A cocktail of drugs like bupivacaine, ketorolac, epinephrine and saline are being used. Peripheral nerve blocks help improves pain control and reduces opioid requirements. Femoral nerve bocks significantly improve analgesia control and shortens the time of functional recovery as compared to epidural analgesia or intravenous opioids. Femoral nerve blocks are associated with reduction in quadriceps strength and increased chances of fall. This in turn delays functional recovery and lengthens hospital stay. Adductor canal block (ACB) is a relatively newer technique for pain management. It helps improve quadriceps function as opposed to femoral nerve blocks which reduces quadriceps function. At the same time, the analgesic effect of adductor canal block is comparable to that of femoral nerve block. Anatomical study of adductor canal showed that the adductor canal contained multiple afferent sensory nerves (e.g. saphenous nerve, medial femoral cutaneous, and medial retinacular nerve etc.) but only a single efferent motor nerve (vastus medialis of the quadriceps muscle) that potentially affected motor function. Therefore, ACB may have a minimal effect on quadriceps muscle strength, but provides a comparable level of pain relief and early mobilization. Pepper et al [1] in their cadaveric study used a 1.5 inch 18 gauge blunt fill needle directed posteriorly at the level of the adductor tubercle in the supracondylar region, angled approximately 15° medial in relation to the sagittal plane, with the needle buried until the syringe hub met resistance to access the adductor canal. They found that this method had an 86% accuracy in accessing the adductor canal with no episode of damage to the femoral artery. They state that intraoperative ACB augmentation of peri articular infiltration is anatomically feasible and safe.

Various studies show that adductor canal block is an effective tool in controlling pain post TKA. [2] Routine practice involves ultrasonography guided adductor canal block given pre operatively. It involves injecting in the distal adductor canal with a success rate as high as 95.6%. Pepper et al found that it was possible to reach the distal adductor canal from the joint, thereby eliminating the need of an extra procedure in giving adductor canal block. Max Greenky et al found that surgeon administered adductor canal block is not inferior to anesthetist administered adductor canal block[3].

 

To the best of our knowledge there is no study assessing the additive effects of adductor canal infiltration given intraoperatively from the joint. (Search engines used : PubMed, OVID, Elsevier, JBJS, Google Scholar).

 

We believe this to be an easy and efficient method of adductor canal infiltration thereby decreasing the cost to the patient and removing the need of an extra invasive procedure after the surgery.

1)ResearchQuestion:Does intraoperative adductor canal infiltration from primary exposure of joint have an additive effect on postoperative pain management and early functional recovery in patients undergoing TKA ?

  Aims :

 To assess additive effect of intraoperative adductor canal infiltration in management of postoperative pain in patients undergoing TKA and  early postoperative function post TKA

 
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