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CTRI Number  CTRI/2024/07/070621 [Registered on: 15/07/2024] Trial Registered Prospectively
Last Modified On: 12/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the comparison of two groups of participants of knee surgeries using blocks as intervention and to compare the effect on pain relief and physical activity as main outcome. 
Scientific Title of Study   Comparison of 4 in 1 block with modified 4 in 1 block using ultrasound for postoperative analgesia in cruciate ligament reconstruction in knee surgeries. 
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 Anju Ghai 
Designation  Senior Professor 
Affiliation  Pt. BD Sharma PGIMS Rohtak 
Address  Department of Anaesthesiology and Critical Care Pt BD Sharma PGIMS Rohtak Haryana

Rohtak
HARYANA
124001
India 
Phone  9416974794  
Fax    
Email  dranjughai@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 Haryana

Rohtak
HARYANA
124001
India 
Phone  8683921867  
Fax    
Email  dr.priyankabansal1986@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Divya Sagar 
Designation  Junior Resident 
Affiliation  Pt. BD Sharma PGIMS Rohtak 
Address  Department of Anaesthesiology and Critical Care Pt BD Sharma PGIMS Rohtak Haryana

Rohtak
HARYANA
124001
India 
Phone  8874693575  
Fax    
Email  divya.sagar18594@gmail.com  
 
Source of Monetary or Material Support  
Pt. BD Sharma PGIMS Rohtak(Material) Rohtak Haryana PIN Code- 124001 India 
 
Primary Sponsor  
Name  Department of Anaesthesiology and Critical Care  
Address  Pt. BD Sharma PGIMS Rohtak Haryana 124001 India 
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 Divya Sagar  Pt. BD Sharma PGIMS Rohtak   Department of Anaesthesiology and Critical Care Pt. BD Sharma PGIMS Rohtak Haryana 124001 India
Rohtak
HARYANA 
8874693575

divya.sagar18594@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: M170||Bilateral primary osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  4 in 1 block  Patients in this group will receive single injection 4 in 1 block using ultrasound with 20 ml bupivacaine 0.25% and 2ml (8mg) dexamethasone as adjuvant [total -22 ml drug]) The 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. The supine position will be maintained with the ipsilateral leg kept in external rotation, slight abduction and knees slightly flexed . The medial femoral condyle will be marked. After sterilization of the linear high frequency ultrasound probe (6–13 Hz) will be used.The probe will be place over the femoral condyle and vastus medialis muscle will be identified and scanned proximally. The vastus and sartorius intersection (antero medial intermuscular septum) will be identified and the probe will be slide proximally till the superficial femoral artery appearing in the adductor hiatus. The probe will slide slowly proximally till the descending genicular artery branching from superficial femoral artery will be visualized in the hiatus. This point will be the pointof interest. The point will be 8–10 cm above the femoral condyle. At this point, 20 mL of 0.25% Bupivacaine and 2ml (8mg) dexamethasone will be injected after confirmation of negative aspiration of blood and no excess pressure upon injection. The needle was guided further in plane from lateral to medial side under USG guidance to reach perivascular region and after negative aspiration 22ml of total drug will be injected, visualized to push the femoral artery posteriorly. The study duration is from July 2023 to June 2024 (1 year) 
Comparator Agent  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 iniection bupivacaine 0.25% and 2ml of iniection 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 US 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 US 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 July 2023 to June 2024 (1 year) 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  ASA I and II ,who are to undergo elective orthopaedic cruciate ligament reconstruction in knee surgery, under subarachnoid block  
 
ExclusionCriteria 
Details  Known hypersensitivity or allergy to study drugs.
Bleeding disorders.
Infection at the site of the block.
Uncontrolled diabetes mellitus and hypertension.
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 4 in 1 block with modified 4 in 1 block using ultrasound for post-operative analgesia in cruciate ligament reconstruction in knee surgeries by comparing the difference of VAS (visual analogue scale) scores between the two groups for 48 hours after surgery.  To compare 4 in 1 block with modified 4 in 1 block using ultrasound for post-operative analgesia in cruciate ligament reconstruction in knee surgeries by comparing the difference of VAS (visual analogue scale) scores between the two groups for 48 hours after surgery. 
 
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 2/ Phase 3 
Date of First Enrollment (India)   25/07/2024 
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 - NO
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 mobilisation 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 nerve block, adductor canal block, sciatic nerve block, IPACK, etc. But these blocks have many drawbacks. Femoral nerve block is associated with quadriceps muscle weakness leading to delay in patient’s mobility. Sciatic nerve 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 20 to 50 years old of either sex belonging to ASA I and II will included in the study. Using computer generated randomisation, patients will be allotted in to two groups of 35 each. One group will receive the newly developed regional technique Modified 4 in 1 block 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 22ml). The second group will receive the 4 in 1 block. In this technique , the vastus and sartorius intersection (antero medial intermuscular septum) will be identified and the probe will be slide proximally till the superficial femoral artery appearing in the adductor hiatus. The probe will slide slowly proximally till the descending genicular artery branching from superficial femoral artery will be visualized in the hiatus. This point will be the point of interest. The point will be 8–10 cm above the femoral condyle. At this point, 20 mL of 0.25% Bupivacaine and 2ml (8mg) dexamethasone will be injected after confirmation of negative aspiration of blood and no excess pressure upon injection. The needle was guided further in plane from lateral to medial side under USG guidance to reach perivascular region and after negative aspiration 22ml of total drug will be injected, visualized to push the femoral artery posteriorly ( total amount of drug given is 22ml). The patient’s vitals, VAS score, total analgesic consumption and quadriceps muscle strength will be noted at regular intervals for 48 hours post operatively and the data will be compiled and will be send for statistical analysis.

 
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