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Total Knee AnthroplastyNCT07643883

IPACK vs Adductor Magnus Plane Block Added to Adductor Canal Block for Total Knee Arthroplasty

A study testing ACB+IPACK and ACB+AMM in people with Total Knee Anthroplasty and Knee Osteoarthritis, run by Ataturk University at 1 site in Turkey (Türkiye).

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

Total knee arthroplasty (TKA) is among the most frequently performed surgical procedures for degenerative joint diseases, including advanced knee osteoarthritis, rheumatoid arthritis, and post-traumatic arthritis. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
What is being tested?
ACB+IPACK and ACB+AMM
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Oct 2023to 6 Feb 2026
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 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Anesthesiologists (ASA) physical status I-II-III
  • Total Knee Arthroplasty Surgery

Who cannot join

  • cardiovascular disease,
  • hepatic dysfunction,
  • coagulopathy or current use of anticoagulant therapy,
  • inability to cooperate,
  • known allergy to any of the study medications,
  • refusal to participate in the study

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ataturk University

    Erzurum, 25000

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of the Effectiveness of IPACK Block Versus Adductor Magnus Muscle Plane Block When Combined With Adductor Canal Block in Total Knee Arthroplasty Surgery

Total knee arthroplasty (TKA) is among the most frequently performed surgical procedures for degenerative joint diseases, including advanced knee osteoarthritis, rheumatoid arthritis, and post-traumatic arthritis. More than 700,000 TKA procedures are performed annually in the United States alone since 2012, with projections estimating a 143% increase by 2050. A significant proportion of patients experience moderate to severe postoperative pain following the procedure, adversely affecting early mobilization, adherence to rehabilitation programs, and ultimately functional recovery .

Femoral nerve block (FNB) was historically the cornerstone of TKA analgesia; however, concerns about quadriceps weakness and associated fall risk led to its replacement by more motor-sparing alternatives . Adductor canal block (ACB) has since become the standard approach, providing analgesia equivalent to FNB while significantly preserving quadriceps strength . Nevertheless, ACB does not adequately cover the posterior capsule and popliteal plexus terminals; consequently, 60-80% of TKA patients report significant posterior knee pain that cannot be sufficiently managed by ACB alone .

Read more

To address this limitation, several posterior knee analgesia techniques have been described. The IPACK (Interspace between Popliteal Artery and Capsule of the Knee) block targets genicular nerve branches and popliteal plexus terminals by injecting local anesthetic between the popliteal artery and the posterior knee capsule, largely sparing the main motor trunks and providing selective posterior analgesia . The adductor magnus muscle plane (AMM) block is a relatively novel interfascial plane block technique applicable in the supine position simultaneously with ACB. By injecting local anesthetic into the fascial plane along the posterior surface of the adductor magnus muscle, the AMM block aims to spread to the popliteal plexus and posterior capsular branches, potentially mimicking a sciatic nerve block effect . A key advantage of the AMM block is its applicability without patient repositioning during the same session as ACB.

The primary objective of this prospective randomized trial was to compare the effects of IPACK and AMM blocks-both added to ACB-on postoperative opioid consumption in patients undergoing TKA. Secondary objectives included evaluating the impact of each technique on postoperative pain scores, mobilization time, functional recovery, and motor function

Read the detailed description

Study Design and Ethical Approval This prospective, randomized, parallel-group trial was approved by the Ethics Committee of Atatürk University Faculty of Medicine (Decision No. 5, Meeting No. 7, dated October 26, 2023). Written informed consent was obtained from all participants before enrollment.

Patients aged 18-75 years with American Society of Anesthesiologists (ASA) physical status I-III scheduled for primary total knee arthroplasty (TKA) were eligible. Exclusion criteria included hepatic, renal, or advanced cardiac insufficiency; neuropathic pain; use of analgesics within 24 hours before surgery; coagulopathy or anticoagulant therapy; advanced cardiovascular disease; allergy to study medications; inability to cooperate; chronic opioid use; and previous lumbar instrumentation.

Of 90 patients assessed for eligibility, 30 were excluded because of chronic renal failure (n = 3), chronic opioid use (n = 5), anticoagulant therapy (n = 8), inability to cooperate (n = 10), or L2-L4 vertebral instrumentation (n = 4). Sixty patients were included and randomized equally into two groups: IPACK (n = 30) and AMM (n = 30).

Randomization and Blinding Participants were randomized in a 1:1 ratio using a computer-generated randomization sequence one hour before surgery. Allocation assignments were concealed in sealed opaque envelopes and delivered to the operating room technician responsible for preparing the intervention.

The anesthesiologist performing the regional block could not be blinded because of the procedural differences. However, patients, surgeons, and the investigator responsible for postoperative outcome assessment were blinded to group allocation.

Regional Anesthesia Procedures ACB Block All patients received an ultrasound-guided adductor canal block (ACB) combined with either an infiltration between the popliteal artery and capsule of the knee (IPACK) block or an adductor magnus muscle plane (AMM) block.

For the ACB, patients were positioned supine with slight external rotation of the hip. After ultrasound identification of the adductor canal, correct needle placement was confirmed with 2 mL of 0.9% saline, followed by injection of 10 mL of 0.5% bupivacaine diluted with 10 mL of 0.9% saline. Dermatomal sensory assessment was performed 5 minutes after injection.

IPACK Block With the patient supine and the knee slightly externally rotated, the ultrasound transducer was placed transversely on the medial aspect of the distal thigh. After identifying the distal femur and popliteal artery, the needle was advanced in-plane into the interspace between the popliteal artery and femur. Following negative aspiration and saline confirmation, 10 mL of 0.5% bupivacaine and 10 mL of saline were injected with intermittent aspiration every 5 mL.

AMM Block The transducer was positioned medially over the distal thigh to identify the adductor muscle compartment. The needle was advanced in-plane from anteromedial to posterolateral until a fascial "pop" indicated entry into the posterior compartment. After negative aspiration and saline confirmation, 10 mL of 0.5% bupivacaine and 10 mL of saline were administered. In the AMM group, the subsequent ACB was performed through needle redirection without a second skin puncture.

For all procedures, needle tip visibility, needle shaft visibility, number of needle insertions, and block performance time were recorded. Dermatomal coverage of the tibial, common peroneal, sural, saphenous, and posterior femoral cutaneous nerves was assessed at 5, 10, 15, 20, 30, and 45 minutes after block placement.

Anesthetic Management Standard monitoring, including electrocardiography, pulse oximetry, and noninvasive blood pressure monitoring, was applied in the operating room. Before spinal anesthesia, patients received intravenous midazolam 2 mg, ondansetron 8 mg, and dexamethasone 8 mg.

Spinal anesthesia was performed under sterile conditions at the L3-L4 or L4-L5 interspace using a 25-gauge spinal needle. Following confirmation of cerebrospinal fluid flow, 15 mg hyperbaric bupivacaine was administered intrathecally. Surgery commenced after a sensory block level of T10 was achieved.

Surgical Technique All TKAs were performed under spinal anesthesia using a standard medial parapatellar approach. After exposure of the knee joint, the anterior cruciate ligament and osteophytes were removed, and femoral and tibial bone cuts were performed using standard alignment guides. Trial components were inserted to assess fit, alignment, stability, and range of motion. Final femoral, tibial, and polyethylene components were implanted using a cemented technique with one package of bone cement.

A negative-pressure intra-articular drain was placed before layered wound closure. The procedure concluded with application of a Jones compression bandage.

Perioperative Analgesia Paracetamol 1 g was administered intravenously 30 minutes before completion of surgery and continued every 8 hours postoperatively. Dexketoprofen trometamol 25 mg was administered intraoperatively 30 minutes before the end of surgery and continued every 12 hours postoperatively.

Postoperative analgesia was provided using intravenous patient-controlled analgesia (PCA) with fentanyl (10 µg/mL concentration, 25 µg bolus dose, 15-minute lockout interval, 48-hour duration). In addition, all patients received paracetamol 1 g three times daily and dexketoprofen 25 mg twice daily as part of a multimodal analgesic regimen.

Patients with a visual analog scale (VAS) score ≥ 4 in the recovery room received rescue tramadol 100 mg intravenously. Patients achieving an Aldrete score ≥ 9 were transferred to the ward.

Outcome Measures The primary outcome was postoperative opioid consumption. Secondary outcomes included postoperative pain scores, motor function, mobilization, and functional recovery.

VAS pain scores and adverse events were recorded at 1, 2, 4, 8, 12, 24, and 48 hours postoperatively. Opioid consumption was assessed during the 0-4, 4-8, and 8-24 hour intervals and as a cumulative 24-hour total.

Motor block of the quadriceps femoris and tibialis anterior muscles was evaluated using a three-point scale (0 = paralysis, 1 = paresis, 2 = normal strength) immediately after surgery and at 12, 24, and 48 hours.

Preoperative assessments included walking aid use, presence of varus-valgus deformity, anterior and posterior VAS scores, Timed Up and Go (TUG) test, quadriceps muscle strength, and active range of motion (ROM). The TUG test measured the time required to stand from a chair, walk 3 meters, return, and sit down. Quadriceps strength was assessed isometrically, and active ROM was measured using a goniometer.

On postoperative days 1 and 2, mobilization time, VAS scores, TUG performance, quadriceps strength, ROM, and the Five Times Sit-to-Stand Test (FTSST) were recorded.

Being tested
ACB+IPACK, ACB+AMM
Keywords
Postoperative Analgesia, Posterior Knee Pain, Ultrasound-Guided Nerve Block
Medical subject headings
Osteoarthritis, Knee

What participants receive

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

  • ACB+IPACKProcedure or surgery

    With the patients in the supine position and the knee slightly externally rotated, the ultrasound transducer will be placed transversely on the medial aspect of the knee, approximately 2-3 cm above the patella. After identifying the distal femoral shaft and the popliteal artery, the needle will be advanced in-plane in an anteromedial direction toward the space between the popliteal artery and the femur. Following negative aspiration and confirmation with normal saline, 10 mL of 0.5% bupivacaine and 10 mL of 0.9% NaCl will be administered, with aspiration performed every 5 mL.

    Needle tip visibility, needle shaft visibility, number of needle insertions, and block duration will be recorded for all procedures.

    Dermatomal spread of the tibial, peroneal, sural, saphenous, and posterior femoral cutaneous nerves (PFCN) will be assessed at predefined time points: 5, 10, 15, 20, 30, and 45 minutes after block administration.

  • ACB+AMMProcedure or surgery

    With patients supine and the leg slightly abducted and externally rotated, the ultrasound probe will be placed 10-15 cm distal to the inguinal crease and moved medially to visualize the adductor muscles. The needle will be advanced in-plane from anteromedial to posterolateral, avoiding the femoral vessels and obturator nerve, until a fascial "pop" indicates entry into the posterior compartment. After negative aspiration and saline confirmation, 10 mL of 0.5% bupivacaine and 10 mL of 0.9% NaCl will be injected. In the AMM group, the adductor canal block will be performed by redirecting the same needle without a second puncture; in the IPACK group, a separate insertion will be used. Dermatomal spread will be assessed at 5, 10, 15, 20, 30, and 45 minutes after block administration.

Study groups in NCT07643883
Study groupRoleWhat they receive
ACB+IPACKActive comparatorParticipants in this arm will receive an ultrasound-guided adductor canal block (20 mL of 0.25% bupivacaine) and IPACK block (20 mL of 0.25% bupivacaine) before surgery. Blocks will be performed under sterile ultrasound guidance by an experienced anesthesiologist who will not participate in postoperative assessments. All patients will receive standardized spinal anesthesia and perioperative analgesia
Receives: Procedure: ACB+IPACK
ACB+AMMActive comparatorAdductor Canal + Adductor Magnus Muscle Plane block: Participants in this arm will receive an ultrasound-guided anterior sciatic nerve block (20 mL of 0.25% bupivacaine) and an adductor canal block (20 mL of 0.25% bupivacaine) before surgery. Blocks will be performed under sterile ultrasound guidance by an experienced anesthesiologist who will not participate in postoperative assessments. All patients will receive standardized spinal anesthesia and perioperative analgesia.
Receives: Procedure: ACB+AMM

What is being measured

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

  1. Opioid consumption

    Postoperative opioid consumption

    Measured: [Time Frame: 0-4 hours, 4-8 hours, 8-24 hours, Total 24-hour]

Secondary outcomes (4)
  1. Pain Scores (VAS) at Rest and During Movement

    Pain intensity will be evaluated using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst pain).

    Assessments will be performed at rest and during movement at predefined postoperative time points.

    Measured: [Time Frame: PACU, 1st hour, 2nd hours, 4th hours, 8th hours, 12th hours, 24th hours,48th hours,]

  2. Adverse Effects

    Opioid-Related Adverse Effects

    Measured: [Time Frame: up to 24 hours]

  3. Evaluation of Nerve Blockade after Nerve Block Application

    Post-block sensory assessment was performed at predefined time intervals using a cold-warm discrimination test.

    Sensory evaluation was conducted at the plantar surface of the foot for the tibial nerve, the dorsal surface of the foot for the superficial peroneal nerve, the posterolateral aspect of the leg for the sural nerve, the posterior aspect of the thigh for the posterior femoral cutaneous nerve, and at the medial malleolus for the saphenous nerve.

    Measured: [Time Frame: 5., 10., 15., 20., 30., and 45. minutes]

  4. Quadriceps and Anterior Tibialis Muscle Strength

    Muscle strength will be assessed using standardized manual muscle testing (paralysis/paresis/normal) for quadriceps and anterior tibialis muscles.

    Measured: [Time Frame: 4th hours, 8th hours, 12th hours, 24th hours, 48th hours]

Timeline

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

  1. First posted12 Jun 2026
  2. Study start10 Oct 2023
  3. Primary completion10 Jan 2024
  4. Study completion6 Feb 2026

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
Model description
Participants and outcome assessors will remain blinded to group allocation. The anesthesiologist performing the block procedures will not participate in postoperative assessments.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07643883
Sponsor's protocol ID
B.30.2.ATA.0.01.00/760
Status last verified
Jun 2026
First submitted
22 May 2026
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ACB+IPACK and ACB+AMM in people with Total Knee Anthroplasty and Knee Osteoarthritis, run by Ataturk University at 1 site in Turkey (Türkiye).

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 2 inclusion and 6 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 12 Jun 2026. 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 Turkey (Türkiye). 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?

Opioid consumption (time frame: [Time Frame: 0-4 hours, 4-8 hours, 8-24 hours, Total 24-hour]). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 12 Jun 2026.

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