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BiFeS vs. iPACK in Postoperative Knee Arthroplasty Analgesia

ConditionsArthroplasty, Replacement, KneePain, PostoperativeAnesthesia, Regional
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAmasya University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Scheduled for unilateral total knee arthroplasty

Classified as ASA physical status I-III

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biceps Femoris Short Head Block (BiFeS)

    Procedure/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 Knee

    Procedure/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 Block

    Procedure/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.

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: Adductor Canal(ACB) + iPACK blockActive comparator 2 interventions
Group B: Adductor Canal(ACB) + BiFeS blockActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Postoperative 12th hour pain score

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

Time frame
Postoperative 12th hour

Secondary outcomes

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

Time frame
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)

Time frame
Postoperative 72th hours
3

Postoperative Cumulative Tramadol Consumption (mg)

Time frame
Postoperative 72th hours
4

Postoperative Complications such as Nausea and Vomiting

Time frame
Every 12 hours during the first 72hours postoperative hours

Other outcomes

Sponsors and contacts

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Amasya University

Lead sponsor

Source ClinicalTrials.gov
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