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Arthroplasty, Replacement, KneeNCT07360392

BiFeS vs. iPACK in Postoperative Knee Arthroplasty Analgesia

A study testing Biceps Femoris Short Head Block (BiFeS), Infiltration Between The Popliteal Artery and The Capsule of The Knee and Adductor Canal Block in people with Arthroplasty, Replacement, Knee and Pain, Postoperative, run by Amasya University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The Biceps Femoris Short Head (BiFeS) block is a new fascial plane block technique targeting the sensory innervation of the posterolateral capsule of the knee while preserving motor function. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Biceps Femoris Short Head Block (BiFeS), Infiltration Between The Popliteal Artery and The Capsule of The Knee and Adductor Canal Block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Apr 2026to 1 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Scheduled for unilateral total knee arthroplasty
  • Classified as ASA physical status I-III

Who cannot join

  • Scheduled for revision arthroplasty or bilateral surgery
  • Allergy to local anesthetics or contraindication to regional blocks
  • Neurological disorders, peripheral neuropathy, or conditions affecting lower extremity muscle strength
  • Coagulopathy or receiving anticoagulant therapy
  • History of severe liver, kidney, or heart failure
  • Chronic opioid use or history of substance abuse
  • Patients experiencing intraoperative complications (e.g., excessive bleeding)
  • Cases in which adequate sensory blockade is not achieved after the block

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Bülent M Çam, MD contact

+90 534 8156011

bulentmericcam@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Amasya University Sabuncuoğlu Şerefeddin Training and Research Hospital

    Amasya, 05200

    Bülent Çam, MD, +90 534 8156011, bulentmericcam@gmail.com

    bulentmericcam@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Postoperative Analgesic Effects of Two Different Anesthesia Techniques in Knee Arthroplasty: Nerve Blocks Named BiFeS and iPACK

The Biceps Femoris Short Head (BiFeS) block is a new fascial plane block technique targeting the sensory innervation of the posterolateral capsule of the knee while preserving motor function. The aim of this study is to evaluate the postoperative analgesic efficacy of the BiFeS block combined with the adductor canal block (ACB) in patients undergoing total knee arthroplasty, compared to ACB + iPACK block. The study is planned as a prospective, randomized, double-blind, parallel two-group trial. Patients will be randomized in a 1:1 ratio to receive ACB + iPACK (Group A) or ACB + BiFeS (Group B). Postoperative pain scores (VAS), opioid consumption, early mobilization, and quality of recovery (QoR-15) outcomes will be compared.

Read the detailed description

Total knee arthroplasty (TKA) is an effective surgical method for the treatment of advanced osteoarthritis, reducing pain and improving functional capacity. However, approximately 30-40% of cases experience severe postoperative pain, and 20-31% of patients develop persistent postoperative pain (1, 2). This not only delays early mobilization and rehabilitation but also negatively affects patient satisfaction and overall recovery.

Enhanced Recovery After Surgery (ERAS) protocols emphasize that effective postoperative analgesia is indispensable for early mobilization and functional recovery. Multimodal analgesic strategies, particularly combinations of motor-sparing regional anesthesia techniques, are a cornerstone of these protocols (3).

One of these regional anesthesia techniques, the femoral nerve block (FNB), provides strong analgesic efficacy but reduces quadriceps strength, increasing the risk of falls. Therefore, in recent years, "motor-sparing" approaches aimed at preserving motor function have gained prominence (4).

Recent high-level network meta-analyses have shown that combinations of motor-sparing regional techniques provide superior outcomes compared to single blocks. In a 2024 meta-analysis by Wang et al., including 30 randomized controlled trials (RCTs), the combination of continuous adductor canal block (cACB) + genicular nerve block (GNB) among motor-sparing approaches provided the lowest rest pain scores at 24 and 48 hours, while cACB + iPACK + GNB combination most effectively reduced pain on movement (5). In the same study, this combination also demonstrated the highest performance in functional recovery indicators, with the shortest Timed-Up-and-Go (TUG) time and greatest range of motion.

Similarly, a 2025 Bayesian network meta-analysis by Migliorini et al., analyzing 77 RCTs, reported the lowest visual analog scale (VAS) scores between postoperative days 1-3 with continuous periarticular analgesia/local infiltration analgesia (PCI/LIA); this was followed by continuous FNB/PCI and continuous ACB applications, respectively (6).

Both analyses emphasized that multimodal approaches, particularly combinations of ACB, iPACK, GNB, or LIA, reduce opioid consumption and support early mobilization.

Another large-scale Bayesian network meta-analysis published by Xue et al. in 2024 reported that the ACB + iPACK combination significantly reduced pain at rest and on movement at 48 hours compared to single blocks (ACB, FNB, GNB, iPACK), decreased opioid consumption, and accelerated early mobilization (7).

However, current techniques have several limitations. LIA is surgeon-dependent, requires a large local anesthetic volume (100-150 mL), and shows variable efficacy due to a lack of standardization in composition/concentration. High volumes also increase the risk of local anesthetic systemic toxicity (LAST). While FNB provides effective pain control, it is not compatible with motor-sparing goals due to quadriceps weakness. Continuous blocks offer analgesic advantages but add logistical burdens due to the need for catheters, pumps, and monitoring.

In this context, new regional techniques are needed that preserve motor function while targeting the sensory innervation of the posterolateral capsule. To address this, the Biceps Femoris Short Head (BiFeS) block, introduced by Kılıçaslan et al. in 2025, is an innovative fascial plane block technique targeting the nerve branches innervating the posterolateral capsule of the knee (8). Ultrasound-guided injection between the short head of the biceps femoris and semimembranosus muscles allows the spread of local anesthetic along the natural fascial plane between these two muscles. This plane constitutes an anatomical corridor including the terminal sensory branches of the common peroneal nerve, the popliteal extension of the posterior femoral cutaneous nerve, and lateral genicular nerve branches. The oblique orientation of muscle fibers facilitates proximal and distal spread of the local anesthetic, creating a broader sensory block encompassing the posterolateral capsule of the knee. Thus, the BiFeS block is expected to provide a wider sensory area than the iPACK block without affecting motor fibers.

Cadaveric studies and early clinical data suggest that the BiFeS block combined with ACB may contribute to multimodal approaches by enhancing postoperative analgesia while preserving motor-sparing efficacy (8). However, no randomized controlled trial has yet demonstrated the clinical effectiveness of this technique.

The hypothesis of this study is that the BiFeS block applied in combination with ACB provides superior postoperative analgesia compared to the iPACK block applied with ACB.

Being tested
Biceps Femoris Short Head Block (BiFeS), Infiltration Between The Popliteal Artery and The Capsule of The Knee, Adductor Canal Block
Keywords
Pain Management, Knee Arthroplasty, BiFes, iPACK, Nerve Block
Medical subject headings
Pain, Postoperative, Agnosia

What participants receive

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

  • Biceps Femoris Short Head Block (BiFeS)Procedure or surgery

    Under ultrasound guidance, the fascial plane between the short head of the biceps femoris and the semimembranosus muscles will be identified. The needle will be advanced into this plane using a lateral approach, and 20 mL of 0.25% bupivacaine will be injected. This injection area forms an anatomical corridor encompassing the terminal sensory branches of the common peroneal nerve, the popliteal extension of the posterior femoral cutaneous nerve, and the lateral genicular nerve branches. Thus, a broad sensory block is achieved along the posterolateral capsule of the knee without affecting motor fibers.

  • Infiltration Between The Popliteal Artery and The Capsule of The KneeProcedure or surgery

    Under ultrasound guidance, the posterior aspect of the popliteal artery at the distal femur, at the level of the femoral condyles, will be targeted. The needle will be advanced using a medial approach, and 20 mL of 0.25% bupivacaine will be injected into the potential space between the artery and the posterior capsule of the knee. This technique blocks the terminal genicular nerve branches innervating the posterior capsule while sparing motor fibers.

  • Adductor Canal BlockProcedure or surgery

    The block will be performed under ultrasound guidance at the distal femoral triangle, just below the apex of the femoral triangle. This level lies deep to the sartorius muscle and represents the lower boundary of the vastoadductor membrane and the beginning of the adductor canal. The ultrasound probe will be placed transversely on the medial thigh to visualize the femoral artery, and the saphenous nerve running lateral to the artery will be targeted. A total of 20 mL of 0.25% bupivacaine will be slowly injected beneath the sartorius muscle and lateral to the femoral artery to allow spread along the adductor canal. This injection at this level affects both the saphenous nerve and the motor branch of the vastus medialis, providing an effective sensory block of the anterior and medial aspects of the knee joint.

Study groups in NCT07360392
Study groupRoleWhat they receive
Adductor Canal(ACB) + iPACK blockActive comparatorNot described
Receives: Procedure: Infiltration Between The Popliteal Artery and The Capsule of The Knee; Procedure: Adductor Canal Block
Adductor Canal(ACB) + BiFeS blockActive comparatorNot described
Receives: Procedure: Biceps Femoris Short Head Block (BiFeS); Procedure: Adductor Canal Block

What is being measured

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

  1. Postoperative 12th hour pain score

    Postoperative 12th hour pain score (will be evaluated with Visuel Analog Scale) Higher scores indicate worse condition

    Measured: Postoperative 12th hour

Secondary outcomes (6)
  1. Postoperative Rest and Movement VAS Scores at 2, 4, 6, 8, 12, 24, 48, 72 Hours and 1, 3 Months

    Higher scores indicate worse condition

    Measured: Postoperative 1st, 2nd, 4th, 8th, 12th, 16th, 24th, 48th hours and 1st ,3th Months

  2. Time to Postoperative Rescue Analgesia (minutes)

    Time to Postoperative Rescue Analgesia (minutes; longer duration indicates slower attainment of VAS score of 4, with higher scores reflecting better analgesia)

    Measured: Postoperative 72th hours

  3. Postoperative Cumulative Tramadol Consumption (mg)

    Measured: Postoperative 72th hours

  4. Postoperative Complications such as Nausea and Vomiting

    Measured: Every 12 hours during the first 72hours postoperative hours

  5. Quality of Recovery-15 (QoR-15) Score

    It is a test used to assess postoperative recovery quality.The Quality of Recovery-15 (QoR-15) scale has a minimum score of 0 and a maximum score of 150, with higher scores indicating better postoperative recovery and lower scores indicating poorer recovery

    Measured: preoperative day 1 and postoperative day 1

  6. Time to Meet Physiotherapy Criteria for Hospital Discharge

    Ability to walk independently from bed to bathroom, walk in the corridor without a walker, and sit down and stand up from a chair independently

    Measured: Every 12 hours during the first 72hours postoperative hours

Timeline

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

  1. First posted22 Jan 2026
  2. Study start20 Apr 2026
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 Jun 2027 (estimated)

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, Outcomes assessor
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07360392
Sponsor's protocol ID
2025-559
Status last verified
Jan 2026
First submitted
30 Dec 2025
Last updated
22 Apr 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 Biceps Femoris Short Head Block (BiFeS), Infiltration Between The Popliteal Artery and The Capsule of The Knee and Adductor Canal Block in people with Arthroplasty, Replacement, Knee and Pain, Postoperative, run by Amasya 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 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: looking for participants now, as of the sponsor's last update on 22 Apr 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Bülent M Çam, MD (+90 534 8156011, bulentmericcam@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative 12th hour pain score (time frame: Postoperative 12th 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 22 Apr 2026.

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