| 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) |
|
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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
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
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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, |
|
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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) |
|
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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 |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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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 |
|
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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
|
|
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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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- 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
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [marjanchyrmang52@gmail.com].
- 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.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
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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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