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NCT Number: NCT07433803

Comparison of the Postoperative Analgesic Efficacy of Infiltration Between the Popliteal Artery and the Capsule of the Knee (iPACK) Block and the Biceps Femoris Short Head Plane (BiFeS) Block in Total Knee Arthroplasty

This study aims to compare the effects of two regional analgesia techniques applied in patients undergoing unilateral total knee arthroplasty-Infiltration between the Popliteal Artery and the Capsule of the Knee (iPACK) block and the Biceps Femoris Short Head Plane (BiFeS) block-on ease of application, postoperative pain scores, time to mobilization, total postoperative opioid consumption, need for first rescue analgesia, and the incidence of nausea-vomiting and pruritus.All patients will be followed postoperatively according to a standard pain management protocol, and pain assessments will be performed at predetermined time intervals using the VAS (Visual Analog Scale).

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Soma State Hospital

Manisa, Soma, 45500, Turkey (Türkiye)

Location contact

Meltem Savas Ozdemir, MD

CONTACT

[email protected]

+905557331143

Pelin Dilsiz Eker, MD

SUB_INVESTIGATOR

About this study

Total knee arthroplasty is one of the most commonly performed orthopedic procedures. Patients experience significant pain in the postoperative period. This pain delays recovery, prolongs the time to mobilization, and increases the length of hospital stay. Currently, multimodal analgesia techniques are used for postoperative pain management. These methods include systemic opioids, epidural analgesia, lumbar plexus block, femoral block, adductor canal block, iPACK block, and the newly defined and proven effective BiFeS block.

In recent years, the adductor canal block has been frequently preferred because it is applied more distally and does not cause motor blockade. It primarily provides analgesia to the anteromedial aspect of the knee.

The iPACK block and the BiFeS block can be used as complementary techniques to the adductor canal block, as they also affect the nerves responsible for the posterolateral innervation of the knee. Since they do not produce motor blockade, they are thought to contribute to early postoperative mobilization. During the iPACK block, local anesthetic is infiltrated between the posterior capsule of the knee and the popliteal artery. It has also been shown that a superior lateral genicular nerve block should be added to this block. The BiFeS block is performed with the patient in the supine position by infiltrating local anesthetic between the short head of the biceps femoris muscle and the lateral femoral condyle at a more proximal level. Due to its distance from the surgical site, the risk of infection is lower.

In this study, the investigators aimed to compare the ease of application and the roles of these blocks-routinely performed at our center as part of multimodal analgesia-in providing effective postoperative analgesia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled for unilateral total knee arthroplasty
  • Patients aged between 18 and 75 years
  • Patients with ASA physical status I-III

Exclusion criteria

  • Patients with neuropsychiatric disorders
  • Patients with obesity (BMI > 30)
  • Presence of local infection at the site where the block will be performed
  • Patients with coagulation disorders
  • Patients with uncontrolled diabetes mellitus
  • Opioid dependence
  • History of allergy to local anesthetic agents
  • Refusal to participate in the study

Treatment and study plan

IPACK block

Procedure

Unilateral iPACK block with 25 mL of mixture 1:1 (0.5 % bupivacaine: 0.9% NaCl)

BiFeS Block

Procedure

Unilateral BiFeS block with 25 mL of mixture 1:1 (0.5 % bupivacaine: 0.9% NaCl)

Primary outcomes

  1. VAS Scores

    Time frame: Postoperative 8th-hour

    A score of 0 indicates no pain, while a score of 10 represents the worst pain imaginable.

Secondary outcomes

  1. VAS Scores

    Time frame: Postoperative 2,4,6,12,24th-hour rest and movement

    A score of 0 indicates no pain, while a score of 10 represents the worst pain imaginable.

  2. Total opioid consumption

    Time frame: 24 hours after surgery

    Patients with a VAS score > 4 will receive 1 mg/kg intravenous tramadol.

  3. Time to first mobilization

    Time frame: 24 hours after surgery

    The postoperative hour at which the patients are comfortably mobilized is recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Meltem Savas Ozdemir, MD

CONTACT

[email protected]

+905557331143

Sponsors and collaborators

Lead sponsor

Soma State Hospital

Other Gov

Registry information

Official study title

Comparison of the Postoperative Analgesic Efficacy of Infiltration Between the Popliteal Artery and the Capsule of the Knee (iPACK) Block and the Biceps Femoris Short Head Plane (BiFeS) Block in Total Knee Arthroplasty: A Prospective, Randomized, Double-Blind, Non-Inferiority Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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