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CTRI Number  CTRI/2023/07/054783 [Registered on: 05/07/2023] Trial Registered Prospectively
Last Modified On: 04/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   EFFECT OF ADDITION OF GENICULAR NERVE BLOCKS TO ADDUCTOR CANAL BLOCKS AND I-PACK BLOCKS IN TOTAL KNEE ARTHROPLASTY PATIENTS. 
Scientific Title of Study   EVALUATION OF ADDITION OF GENICULAR NERVE BLOCKS TO STANDARD ADDUCTOR CANAL BLOCKS AND I-PACK BLOCKS IN PRIMARY TOTAL KNEE ARTHROPLASTY-A RANDOMISED CONTROLLED TRIAL. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Sonaxi Das 
Designation  PG student 
Affiliation  NORTHERN RAILWAY CENTRAL HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIA NORTHERN RAILWAY CENTRAL HOSPITAL
NRCH, BASANT LANE, New Delhi, 110055
Central
DELHI
110049
India 
Phone  8249477429  
Fax  011-23363469  
Email  sonaxidas11@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. SUSHIL KRISHNAN 
Designation  ACHD, CONSULTANT 
Affiliation  NORTHERN RAILWAY CENTRAL HOSPITAL 
Address  Northern Railway Central Hospital, Basant Lane, Delhi
NRCH, BASANT LANE, New Delhi, 110055
Central
DELHI
110055
India 
Phone  9717630552  
Fax  011-23363469  
Email  dr.sushilkrishnan@gmail.com  
 
Details of Contact Person
Public Query  
Name  SONAXI DAS 
Designation  PG student 
Affiliation  NORTHERN RAILWAY CENTRAL HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIA NORTHERN RAILWAY CENTRAL HOSPITAL
NRCH, BASANT LANE, New Delhi, 110055
Central
DELHI
110049
India 
Phone  8249477429  
Fax  011-23363469  
Email  sonaxidas11@gmail.com  
 
Source of Monetary or Material Support  
DEPARTMENT OF ANAESTHESIOLOGY NORTHERN RAILWAY CENTRAL HOSPITAL,BASANT LANE, New Delhi-110055 
 
Primary Sponsor  
Name  NORTHERN RAILWAY CENTRAL HOSPITAL  
Address  NRCH, BASANT LANE, New Delhi-110055 
Type of Sponsor  Research institution and hospital 
 
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 SONAXI DAS  NORTHERN RAILWAY CENTRAL HOSPITAL  DEPARTMENT OF ANAESTHESIOLOGY
Central
DELHI 		 8249477429
011-23363469
sonaxidas11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Northern Railway Central Hospital, IEC-NRCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  GENICULAR NERVE BLOCKS  ADDITION OF GENICULAR NERVE BLOCK TO STANDARD ADDUCTOR CANAL BLOCK AND I-PACK BLOCKS IN PATIENTS UNDERGOING TKA WITH INJECTION ROPIVACAINE 0.5% 2.5 ML FOR EACH GENICULAR NERVE AROUND KNEE JOINT.THE PAIN SCORE(VRS) WILL BE ASSESSED OVER A DURATION OF 24 HOURS AND IF THE PAIN SCORE IS MORE THAN 4 THEN THE PATIENTS WILL RECEIVE ADDITIONAL RESCUE ANALGESIA IN TERMS OF OPIOIDS. 
Intervention  STANDARD ADDUCTOR CANAL BLOCKS AND I-PACK BLOCKS  Patients undergoing Total knee Arthroplasty will be given Adductor canal block catheter and I-PACK blocks for post operative analgesia with injection ROPIVACAINE 0.5% 15 ml for the I-PACK block and the adductor canal catheter infusion will be started with Injection ROPIVACAINE 0.2% at rate of 4ml/ hr in the post anaesthetic care unit(PACU) which will kept for 24hrs for assessment of post operative analgesia in terms of morphine equivalents. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  ASA GRADE 1-3
BMI-18 TO 35 KG/M2
SCHEDULED FOR PRIMARY TOTAL KNEE ARTHROPLASTY SURGERY. 
 
ExclusionCriteria 
Details  Known allergy or intolerance to ropivacaine , bupivacaine or other local anaesthetics
Contraindication to peripheral nerve block(eg- local infection, neurologic deficit or disorder, previous trauma or surgery of ipsilateral knee, etc.)
Any history of chronic pain
Chronic opioid consumption(daily morphine equivalent of >30 mg for at least four weeks prior to surgery)
Receiving general anaesthesia
Hepatic or renal insufficiency
History of psychiatric disorder
History of Epilepsy or Seizure disorder
significant coagulopathy (platelet count <75000/ml or international normalized ratio >1.5)
Revision surgery
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Total morphine equivalents given to the patient over and above the standard pain analgesia protocol in patients undergoing total knee replacement surgery.  24 hours
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
Final Enrollment numbers achieved (Total)= "58"
Final Enrollment numbers achieved (India)="58" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   20/07/2023 
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="1"
Months="6"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 NONE YET 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sonaxidas11@gmail.com].

  6. For how long will this data be available start date provided 20-06-2023 and end date provided 30-03-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 Patients will be categorised into 2 groups- Group A-patients receiving Genicular nerve blocks in addition to standard Adductor canal blocks and 
I-PACKS. Group B-patients receiving only adductor canal blocks(ACBs) +I-PACKS.

On the day of surgery, in all patients, routine spinal anesthesia using 12.5mg(2.5ml) hyperbaric bupivcaine will be given.After confirming the hemodynamic stability of the patients, patients in the 2 groups will undergo blocks using ultrasound as follows: All patients will receive I-PACK blocks using 15ml of 0.375% Ropivacaine and Adductor canal block catheter will be placed( infusion of 0.25% ropivacaine will be started only after the surgery at the rate of 4ml/hr).These will be placed using standard protocols.
In addition one group will receive Genicular nerve blocks using 0.5% ropivacaine( 2ml each for the superolateral, superomedial, inferomedial genicular nerves).
At the end of surgery patient will be shifted to PACU, where the continuous ACB infusion will be started.
A standardised protocol of oral paracetamol 650mg 6hourly and injection diclofenac 50mg will be given 12hourly.
Those patients who reported pain score(NRS> EQUAL TO 4) will be randomised to receive rescue analgesia which will be one of the following- morphine 10mg=buprenorphine 0.4mg=butorphanol 2mg=nalbuphine 10 mg.
At the end of 24hrs, total rescue analgesia given will be calculated in morphine equivalents.
 
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