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Post Operative PainNCT06423339

Comparison Between (GNB) Combined With (IPACK) Block Versus ACB in TKA

A study testing Ultrasound guided Genicular nerve block, Interspace between the popliteal artery and the capsule of the popliteal artery and the capsule of the posterior knee and Adductor canal block in people with Post Operative Pain, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The patients will be randomized into 2 groups, named group A, B. Group A: The patients will receive Ultrasound guided Genicular nerves block combined with Ultrasound guided IPACK block. Group B: The patients will receive Adductor canal block which will be the control group. Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Post Operative Pain
What is being tested?
Ultrasound guided Genicular nerve block, Interspace between the popliteal artery and the capsule of the popliteal artery and the capsule of the posterior knee and Adductor canal block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
10 May 2024to 30 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients American Society of anesthesiologists' physical status (ASA) I to III.
  • Aged 40 to 70 years.
  • Both sexes.
  • Patients scheduled for unilateral total knee replacement.

Who cannot join

  • Patients with spinal malformation
  • Patients with liver impairment
  • Patients with renal impairment
  • Patients younger than 40 years or older than 70 years
  • Patients with hypersensitivity to one of the used drugs
  • Patients with neuromuscular disorders and
  • Coagulopathy disorders
  • Patients scheduled for revision knee arthroplasty or those who had a past history of previous surgery or trauma to the knee

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Ain shams university hospitals

    Cairo

Other trials in Egypt

About this study

Official title: A Comparative Study Between Ultrasound Guided Genicular Nerve Block Combined With Interspace Between the Popliteal Artery and the Capsule of the Posterior Knee Block Versus Adductor Canal Block in Total Knee Replacement

The patients will be randomized into 2 groups, named group A, B.

Group A: The patients will receive Ultrasound guided Genicular nerves block combined with Ultrasound guided IPACK block.

Read more

Group B: The patients will receive Adductor canal block which will be the control group.

The Numerical Rating Scale (NRS) will be used to assess pain intensity. Preoperatively, all study subjects will be trained to use NRS pain scores.

The spinal block will be performed.

In group A, 15 mL of bupivacaine 0.25% with 2.5 g/mL adrenaline at a concentration 1:4,00,000 will be administered immediately following skin closure. GNB will be performed by using the linear ultrasound probe (10-15 MHz) Sono site M-turbo ultrasonography to scan the long bone shaft with up and down movement to recognize the epicondyle of the tibia and femur. The junctions between the epicondyle and the shafts of the femur and tibia are where the genicular arteries are located; these junctions will be defined as the periosteal areas. The superior lateral, superior medial and inferior medial genicular arteries accompany each genicular nerve. After confirmation of the genicular artery by color Doppler, the needle will be introduced using the in-plane approach and presented in the long axis view. The target point of the needle insertion will be the needle tip beside a genicular artery. Then, a 5 mL volume will be administered after gentle aspiration to prevent a faulty intra-arterial injection at 3 target locations: the superior lateral, superior medial and inferior medial genicular nerves.

This will be Followed by the procedure for the IPACK block.

In group B, A 22 Gauge 80 mm needle will be guided from lateral to medial to this area called the adductor canal using in-plane technique. 20 mL of 0.5% bupivacaine will be injected with peri-arterial spread after negative aspiration under sterile conditions. TKA will be performed by an orthopedic surgeon by placing three-compartment prostheses with a minimally invasive mini-midvastus approach and using hand-mixed cementing techniques.

Read the detailed description

The patients will be randomized into 2 equal groups by a computer-generated random numbers table, named group A, B. An independent data manager of computer generated software will be responsible for randomization, assigning the patients to the groups using sequentially numbered, sealed, opaque envelopes containing computer generated random numbers, accessible only to the anesthesiologist performing the block. The subjects will be randomly allocated to one of the two groups.

Group A: The patients will receive Ultrasound guided Genicular nerves block combined with Ultrasound guided IPACK block.

Group B: The patients will receive Adductor canal block which will be the control group.

History taking, clinical examination and routine laboratory investigation will be performed preoperatively, and the patients will be instructed to fast for 8 hours preoperative for solids and 2 hours for clear fluids. On arrival to the operation room, intravenous access will be established and acetated ringer will be infused by rate 10ml/kg. ECG, noninvasive blood pressure and arterial oxygen saturation will be monitored routinely. The Numerical Rating Scale (NRS) will be used to assess pain intensity. Preoperatively, all study subjects will be trained to use NRS pain scores.

In the operating room, a peripheral 20 G intravenous (IV) cannula will be inserted. The baseline parameters of five lead electrocardiogram (ECG), non invasive blood pressure and peripheral oxygen saturation will be recorded. IV midazolam 0.02 mg/kg will be administered. The spinal block will be performed using either a 25 or 27 G spinal needle in the sitting position at the L3-L4 or L4-L5 intervertebral space with a 2.5-3 mL hyperbaric bupivacaine 0.5%. The sensory block (to cold and pinprick) to the 10th thoracic dermatome or above will be the target of the spinal block to start the surgery. Hypotension will be defined as ≥20% decrease in blood pressure from baseline measurements and managed by IV Ephedrine6 mg boluses.

In group A, 15 mL of bupivacaine 0.25% with 2.5 g/mL adrenaline at a concentration 1:4,00,000 will be administered immediately following skin closure. GNB will be performed by using the linear ultrasound probe (10-15 MHz) Sono site M-turbo ultrasonography to scan the long bone shaft with up and down movement to recognize the epicondyle of the tibia and femur. The junctions between the epicondyle and the shafts of the femur and tibia are where the genicular arteries are located; these junctions will be defined as the periosteal areas. The superior lateral, superior medial and inferior medial genicular arteries accompany each genicular nerve. After confirmation of the genicular artery by color Doppler, the needle will be introduced using the in plane approach and presented in the long axis view. The target point of the needle insertion will be the needle tip beside a genicular artery. Then, a 5 mL volume will be administered after gentle aspiration to prevent a faulty intra arterial injection at 3 target locations: the superior lateral, superior medial and inferior medial genicular nerves.

This will be Followed by the procedure for the IPACK block initiated by the visualization of the popliteal artery and posterior surface of the distal femur. Then, the image of the femoral condyles and the popliteal artery will be obtained. A 20G 22G 80 mm needle will be inserted in a medial to the lateral plane, parallel to the femur in the middle area between the popliteal artery and the femur. 20 mL of the local anesthetic solution will be given into this space in increments, ensuring the adequate and equal distribution of the anesthetic agent.

In group B, after placing the patients in the supine position, the linear probe of ultrasound (13-6 MHz) will be moved from cephalad to caudal and the superficial femoral artery will be visualized in the short axis, medial to the vastus medialis, lateral to the sartorius muscle, and anterior to the adductor magnus muscle.

A 22 Gauge 80 mm needle will be guided from lateral to medial to this area called the adductor canal using in-plane technique. 20 mL of 0.5% bupivacaine will be injected to with peri-arterial spread after negative aspiration under sterile conditions. TKA will be performed by an orthopedic surgeon by placing three-compartment prostheses with a minimally invasive mini-midvastus approach and using hand-mixed cementing techniques.

The outcome:

The primary outcome will be the total postoperative morphine consumption during the first two postoperative days. NRS will be assessed at 0, 6, 12, 24 and 48 h postoperatively. The period between the end of surgery and the first request for rescue analgesia (NRS >3) will be considered the time to the first request. Postoperative analgesia, IV paracetamol (1 g/6 h) and IV ketorolac (30 mg/12 h), will be administered to all patients. The pain will be assessed at rest and during movement using NRS (metric score 0-10 for pain severity assessment: mild pain = 1-3, moderate = 4-7 and severe = 8 and above) on the first and second days. When NRS will be >3, rescue analgesia (morphine 3 mg IV) will be given and repeated whenever required.

The secondary outcome will be assessment of Postoperative functional outcomes and knee rehabilitation parameters including quadriceps motor strength score measured by straight leg raising (SLR), knee range of motion (ROM) and time up and go (TUG) test. SLR will be assessed on a scale ranging from 0 to 5 as follows: 0 = unable to contract muscles, 1 = muscles twitch, the limb does not move, 2 = able to move the limb with gravity elimination and passive assistance, 3 = able to move the limb against gravity without resistance (no cuff weights weight wrapped around your thigh just above your kneecap), 4 = move the limb against some resistance (cuff weights weight wrapped around your thigh just above your kneecap) and 5 = normal motor strength against resistance. TUG is a performance test to measure functional mobility. The test requirements will be presented as the subject rises from a chair, walks 3.0 m easily to reach a mark placed on the floor, turns around at the 3.0 m mark, returns to the starting point and sits on the chair. The time the subject takes to complete the test is defined as the TUG score. Patients' movement with aid within 24 h will be encouraged when the motor strength was at least two. The postoperative patient satisfaction and incidence of adverse effects will be recorded. Patient satisfaction will be measured by a self administered satisfaction scale (very satisfied, somewhat satisfied, somewhat dissatisfied, very dissatisfied).

Being tested
Ultrasound guided Genicular nerve block, Interspace between the popliteal artery and the capsule of the popliteal artery and the capsule of the posterior knee, Adductor canal block, Bupivacaine Hydrochloride
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound guided Genicular nerve blockProcedure or surgery

    Ultrasound guided genicular nerve block

  • Interspace between the popliteal artery and the capsule of the popliteal artery and the capsule of the posterior kneeProcedure or surgery

    Ultrasound guided Interspace between the popliteal artery and the capsule of the popliteal artery and the capsule of the posterior knee

  • Adductor canal blockProcedure or surgery

    Ultrasound guided sub-sartorial Adductor canal block

  • Bupivacaine HydrochlorideDrug

    Also called Sunnypivacaine

    Pupivacaine 0.5% in 20 ml vial

Study groups in NCT06423339
Study groupRoleWhat they receive
Group AExperimentalGroup A will receive genicular nerve block combined with interspace between the popliteal artery and the capsule of the posterior knee block(IPACK)
Receives: Procedure: Ultrasound guided Genicular nerve block; Procedure: Interspace between the popliteal artery and the capsule of the popliteal artery and the capsule of the posterior knee; Drug: Bupivacaine Hydrochloride
Group BExperimentalGroup B will receive ultrasound guided sub-sartorial Adductor canal block (ACB)
Receives: Procedure: Adductor canal block; Drug: Bupivacaine Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary outcome will be the total postoperative morphine consumption during the first two postoperative days.

    The primary outcome will be the total postoperative morphine consumption during the first two postoperative days.

    Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2024
  2. Study start10 May 2024
  3. Primary completion30 Nov 2024
  4. Study completion30 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06423339
Sponsor's protocol ID
FAMSU R80/2024
Status last verified
Jan 2025
First submitted
27 Apr 2024
Last updated
7 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Abouseeda MM, Rashed MM, Hussein MM, Nady RF, Ehab AM. A Comparative Study Between Ultrasound-Guided Genicular Nerve Block Combined With Interspace Between the Popliteal Artery and the Capsule of the Posterior Knee Block versus Adductor Canal Block in Total Knee Replacement. Anesthesiol Res Pract. 2025 May 22;2025:8937826. doi: 10.1155/anrp/8937826. eCollection 2025.

    PubMed 40444065

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound guided Genicular nerve block, Interspace between the popliteal artery and the capsule of the popliteal artery and the capsule of the posterior knee and Adductor canal block in people with Post Operative Pain, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary outcome will be the total postoperative morphine consumption during the first two postoperative days. (time frame: 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06423339, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.

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