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CTRI Number  CTRI/2024/03/064819 [Registered on: 27/03/2024] Trial Registered Prospectively
Last Modified On: 01/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between different blocks for knee surgeries 
Scientific Title of Study   Comparison between ultrasound guided modified 4 in 1 block with combined adductor canal and Injection between Popliteal Artery and Capsule of the Knee (IPACK) for postoperative analgesia in Total knee arthroplasty 
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 Priyanka Bansal 
Designation  Associate Professor 
Affiliation  Pt. BD Sharma PGIMS, Rohtak 
Address  Department of Anaesthesiology and Critical care Pt. BD Sharma PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  8683921867  
Fax    
Email  dr.priyankabansal1986@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Priyanka Bansal 
Designation  Associate Professor 
Affiliation  Pt. BD Sharma PGIMS, Rohtak 
Address  Department of Anaesthesiology and Critical care Pt. BD Sharma PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  8683921867  
Fax    
Email  dr.priyankabansal1986@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Marjan Wao Chyrmang 
Designation  Junior Resident 
Affiliation  Pt. BD Sharma PGIMS, Rohtak 
Address  Department of Anaesthesiology and Critical care Pt. BD Sharma PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  7760444426  
Fax    
Email  marjanchyrmang52@gmail.com  
 
Source of Monetary or Material Support  
Pt. BD Sharma PGIMS Rohtak (material) 
 
Primary Sponsor  
Name  Department of Anaesthesiology and Critical Care 
Address  Pt. BD Sharma PGIMS Rohtak 
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 
Dr Marjan Wao Chyrmang  Pt. BD Sharma PGIMS Rohtak Haryana  Department of Anaesthesia and Critical Care
Rohtak
HARYANA 
7760444426

marjanchyrmang52@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M174||Other bilateral secondary osteoarthritis of knee, (2) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Adductor canal block and Injection between popliteal artery and capsule of the knee (IPACK)  Patients in this group will receive ultrasound guided Adductor canal block and IPACK block with 12ml and 10ml respectively of 20ml injection bupivacaine 0.25% and 2ml of injection dexamethasone 8mg added as adjuvant respectively (total volume of drug 22 ml). The Adductor canal is identified in the middle of the thigh beneath the sartorius muscle using a high-frequency ultrasonic transducer, the probe is slid till the superficial femoral artery appeared in the adductor canal between vastus medialis and adductor longus muscle. A 22-gauge spinal needle is inserted in a lateral to medial plane to reach the perivascular region and after negative aspiration 12 ml of the drug will be injected, visualised to push the femoral artery after confirmation of negative aspiration. For IPACK block the patient is placed in frog leg position and a roll of blanket is placed under the thigh to support it. The transducer is placed on the lower third of the medial thigh to visualize the femur and the femoral vessels in cross-section. The transducer is then slid caudally observing the femoral artery as it dives into the popliteal fossa through the adductor hiatus to become the popliteal artery. At this point, the transducer is moved posteriorly and inferiorly to visualize the space between the popliteal artery and the shaft of the femur just superior to the femoral condyles. The needle is inserted in plane from the anterior end of the transducer in a medial to lateral trajectory, keeping the needle parallel to the acoustic shadow of the femur. With the needle tip resting 2 cm beyond the lateral border of the artery 10 ml of drug is injected, after negative aspiration. the study duration is from June 2024 to June 2025 (1 year) 
Intervention  Modified 4 in 1 block  The Modified 4 in 1 block technique aims to block four nerves (saphenous nerve, obturator nerve, nerve to vastus medialis and sciatic nerve) through a single injection point by spreading up to the adductor canal in mid thigh and below to the popliteal fossa. Under all aseptic precautions patients will receive 20ml injection bupivacaine 0.25% and 2ml of injection dexamethasone 8mg added as adjuvant (total volume of drug 22 ml). In frog leg position using a linear high frequency ultrasound probe the descending genicular artery branching from superficial femoral artery was visualized in the hiatus. At this point the needle was guided under USG guidance into the Vastus medialis muscle till the stimulation of the nerve to Vastus medialis, generating a Vastus medialis contraction, which was elicited at the threshold current of 0.4‑0.5 mA. At this point 5mL of drug will be injected after confirmation of negative aspiration, the needle was guided further in plane from lateral to medial side under USG guidance to reach perivascular region and after negative aspiration rest of the drug (17 ml) was injected while visualizing the femoral artery being push posteriorly. the study duration is from June 2024 to June 2025 (1 year) 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  ASA I, II, III undergoing elective orthopedic total knee arthroplasty under subarachnoid block 
 
ExclusionCriteria 
Details  Known hypersensitivity or allergy to study drugs
bleeding disorders
infection at the site of block
uncontrolled diabetic and hypertensive
history of cardiac, liver or kidney disease
patient not willing to participate in the study 
 
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 
To compare ultrasound guided Modified 4 in 1 block with combined Adductor canal and IPACK block for post-operative analgesia in total knee arthroplasty by comparing the difference of VAS scores between the two groups for 48 hours after surgery
 
Patients VAS score will be assessed before the start of surgery and at 6, 12, 24, 48 hours post operatively 
 
Secondary Outcome  
Outcome  TimePoints 
To note duration of postoperative analgesia using VAS in both groups up to 48hours after surgery.
To note the site of pain, whether it is medial, lateral or upper side of knee
To note the amount and type of rescue analgesia required.
To note the extent of ambulation after 24 hours of surgery
To note the quadriceps muscle strength after 24 hours of surgery using the quadriceps strength test
To note the complications if any
To note patients overall experience score
 
The Quadriceps muscles strength will be tested at 24, 36 and 48 hour post operatively
 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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   Phase 1 
Date of First Enrollment (India)   01/06/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
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 - All of the individual participant data collected during the trial, after de-identification.

  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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [marjanchyrmang52@gmail.com].

  6. For how long will this data be available start date provided 01-03-2024 and end date provided 01-03-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Total knee arthroplasty or replacement (TKA), arthroscopic knee surgeries are one of the most commonly performed, life-changing surgical procedures, leading to improved health-related quality of life and functional status, therefore these surgeries demand better outcomes with minimal morbidity and mortality and early mobilization and discharge. The central neuraxial blocks were associated with higher complications, morbidity and delayed ambulation. The regional techniques provide a better and early outcome as compared to the central neuraxial techniques. Regional analgesia (RA) is an important component of multimodal analgesia to deal with perioperative pain. Regional anaesthesia includes epidural analgesia, femoral n. block, adductor canal block, sciatic n. block, IPACK, etc. But these blocks have many drawbacks. Femoral n. block is associated with quadriceps muscle weakness leading to delay in patient’s mobility. Sciatic n. block also causes foot drop. The Adductor canal block does not cover the skin on the back of the knee. Surgeons refuse IPACK because of diffusion of local anaesthetics disturbs the anatomy of the surgical field. 70 Patients between the age group of 45 to 75 years old of either sex belonging to ASA I, II, III will included in the study. Using computer generated randomization, patients will be allotted in to two groups of 35 each. One group will receive the newly developed regional technique Modified 4 in 1 with the addition of USG and PNS guided Vastus medialis nerve block. The patients in this block will receive 20ml injection bupivacaine 0.25% and 2ml of injection dexamethasone 8mg added as adjuvant (total volume of drug 22 ml). The second group will receive the ACB and IPACK block. ACB is as effective as FNB in providing postoperative analgesia after knee surgery and ACB carries the advantage of preserving or minimally affecting quadriceps strength thereby facilitating early ambulation and postoperative rehabilitation. A new regional analgesia technique known as IPACK (infiltration between popliteal artery and capsule of the knee) has been used in practice since 2014. In this technique the superomedial and lateral genicular nerves,branches of the sciatic nerve and articular branches of the obturator nerve in the popliteal region are blocked providing analgesia to the posterior capsule of the knee joint, without affecting motor function of the limb. Patients in this group will receive ultrasound guided Adductor canal block and IPACK block with 12ml and 10ml respectively of 20ml injection bupivacaine 0.25% and 2ml of injection dexamethasone 8mg added as adjuvant respectively (total volume of drug 22 ml). The patient’s vitals, VAS score, total analgesic consumption, quadriceps muscle strength will be noted at regular intervals for 48 hours post operatively and the data will be compiled and sent for statistical analysis.


 

 

 

 
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