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CTRI Number  CTRI/2018/01/011364 [Registered on: 16/01/2018] Trial Registered Retrospectively
Last Modified On: 15/01/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to study the efficacy of two different types of pain killers in patients undergoing total knee replacement 
Scientific Title of Study   To compare the analgesic efficacy of combined adductor and genicular block with adductor canal block for total knee arthroplasty : A double blind randomized clinical trial   
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MITHUN MANOHAR M 
Designation  FELLOW IN ARTHROPLASTY 
Affiliation  ORTHOPAEDICS DEPARTMENT, SUNSHINE HOSPITALS 
Address  Sunshine Hospitals Penderghast Road, Opposite Parsi Dharamsala, Behind Paradise Hotel, Secunderabad, Telangana , India
Sunshine Hospitals Penderghast Road, Opposite Parsi Dharamsala, Behind Paradise Hotel, Secunderabad, Telangana , India
Hyderabad
ANDHRA PRADESH
500003
India 
Phone    
Fax    
Email  manoharmithun@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  MITHUN MANOHAR M 
Designation  FELLOW IN ARTHROPLASTY 
Affiliation  ORTHOPAEDICS DEPARTMENT, SUNSHINE HOSPITALS 
Address  Sunshine Hospitals Penderghast Road, Opposite Parsi Dharamsala, Behind Paradise Hotel, Secunderabad, Telangana , India
Sunshine Hospitals Penderghast Road, Opposite Parsi Dharamsala, Behind Paradise Hotel, Secunderabad, Telangana , India
Hyderabad
ANDHRA PRADESH
500003
India 
Phone    
Fax    
Email  manoharmithun@gmail.com  
 
Details of Contact Person
Public Query  
Name  MITHUN MANOHAR M 
Designation  FELLOW IN ARTHROPLASTY 
Affiliation  ORTHOPAEDICS DEPARTMENT, SUNSHINE HOSPITALS 
Address  Sunshine Hospitals Penderghast Road, Opposite Parsi Dharamsala, Behind Paradise Hotel, Secunderabad, Telangana , India
Sunshine Hospitals Penderghast Road, Opposite Parsi Dharamsala, Behind Paradise Hotel, Secunderabad, Telangana , India
Hyderabad
ANDHRA PRADESH
500003
India 
Phone    
Fax    
Email  manoharmithun@gmail.com  
 
Source of Monetary or Material Support  
AV GURAVA REDDY, MANAGING DIRECTOR, SUNSHINE HOSPITALS, PENDERGHAST ROAD, OPPOSITE PARSI DHARAMSALA, PARADISE, SECUNDERABAD, TELENGANA - 500003 
 
Primary Sponsor  
Name  AV GURAVA REDDY 
Address  Penderghast Road, Opposite Parsi Dharamsala, Behind Paradise Hotel, Secunderabad, Telangana 500003 
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 
AV GURAVA REDDY  Department of Orthopaedics, arthroplasty division, SUNSHINE HOSPITAL , SECUNDERABAD  Penderghast Road, Opposite Parsi Dharamsala, Behind Paradise Hotel, Secunderabad, Telangana 500003
Hyderabad
ANDHRA PRADESH 		 04044550000

guravareddy@sunshinehospitals.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee sunshine hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  osteoarthritis knee joint,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ACB and IPACK block  20ml of 0.2% ropivacaine for ACB and IPACK each. 
Comparator Agent  ACB and sham injection  ACB : 20ml of 0.2 % ropivacaine. Sham injection : using normal saline 20 ml to mimic the procedure of IPACK block. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Age 18-90 years (adults and elderly)
2. The American Society of Anesthesiologists (ASA) Physical Status 1-3
3. Either gender
4. patients undergoing primary unilateral total knee arthroplasty
5. serum creatinine below 1.5 
 
ExclusionCriteria 
Details  1. Age < 18 or > 90 years
2. Use of general anaesthesia during the operative procedure
3. If indication of surgery is for rheumatoid arthritis, inflammatory arthropathy, bilateral TKA
or revision of TKA
4. Any contraindications to regional blockage or ropivacaine including but not limited to
• Patient’s refusal to usage of regional blockade
• Infection at the site of needle insertion
• Systemic infection
• Bleeding diathesis or coagulopathy (as diagnosed by history or laboratory
evaluation)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The efficacy of pain management will assessed by a VAS (Visual Analogue Scale) that measures 10 cm.
 		 The assessments will be done on post-operative days 1,2 and 3 by a single assessor 
 
Secondary Outcome  
Outcome  TimePoints 
range of movement using goniometer  Range of movement was measured on Day 1 after the dressing
in morning  
distance walked on day 1  Number of steps walked by the patient on post operative Day 1 morning was
recorded 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
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)   01/10/2017 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Pain management in total knee arthroplasty is aimed to minimize postoperative pain and improve functional outcomes in patients. Although there are many methods used for controlling the pain there has been no consensus on most appropriate or the best protocol. Adductor canal block (ACB) has the unique advantage of providing localized analgesia but it doesn’t provide pain relief to the posterior capsule, it has been postulated that IPACK (interspace between the popliteal artery and the capsule of the knee) combined with ACB will provide better pain relief than ACB alone. 
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