| 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
|
|
|
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
|
|
|
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. |