BiFeS vs. iPACK in Postoperative Knee Arthroplasty Analgesia

NCT07360392 | Recruiting

• 1 other identifier: 2025-559
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Arthroplasty, Replacement, Knee; Pain, Postoperative; Anesthesia, Regional

Keywords

Pain Management; Knee Arthroplasty; BiFes; iPACK; Nerve Block

Outcome Measures

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

  Postoperative 12th hour

Secondary Outcomes (6)

• Postoperative Rest and Movement VAS Scores at 2, 4, 6, 8, 12, 24, 48, 72 Hours and 1, 3 Months

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

• Time to Postoperative Rescue Analgesia (minutes)

  Postoperative 72th hours

• Postoperative Cumulative Tramadol Consumption (mg)

  Postoperative 72th hours

• Postoperative Complications such as Nausea and Vomiting

  Every 12 hours during the first 72hours postoperative hours

• Quality of Recovery-15 (QoR-15) Score

  preoperative day 1 and postoperative day 1

Study Arms (2)

Adductor Canal(ACB) + iPACK block

ACTIVE COMPARATOR

Procedure: Infiltration Between The Popliteal Artery and The Capsule of The Knee; Procedure: Adductor Canal Block

Adductor Canal(ACB) + BiFeS block

ACTIVE COMPARATOR

Procedure: Biceps Femoris Short Head Block (BiFeS); Procedure: Adductor Canal Block

Interventions

Biceps Femoris Short Head Block (BiFeS) PROCEDURE

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.

Adductor Canal(ACB) + BiFeS block

Infiltration Between The Popliteal Artery and The Capsule of The Knee PROCEDURE

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(ACB) + iPACK block

Adductor Canal Block PROCEDURE

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.

Adductor Canal(ACB) + BiFeS block; Adductor Canal(ACB) + iPACK block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amasya University: lead

Study Sites (1)

Amasya University Sabuncuoğlu Şerefeddin Training and Research Hospital

Amasya, 05200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Central Study Contacts

Bülent M Çam, MD

CONTACT

+90 534 8156011; bulentmericcam@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Physician

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 22, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)