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

April 28, 2026 updated by: Meltem Savas Ozdemir, Soma State Hospital

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Soma
      • Manisa, Soma, Turkey (Türkiye), 45500
        • Soma State Hospital
        • Contact:
        • Sub-Investigator:
          • Pelin Dilsiz Eker, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: iPACK Block
At the end of surgery, all patients will receive an adductor canal block in the recovery unit under sterile conditions and ultrasound guidance using 10 mL of 0.25% bupivacaine. In addition, in the iPACK block group, the patient will be positioned in the lateral decubitus position, and under sterile conditions, a linear ultrasound probe will be used to advance a 22G, 100-mm block needle to the space between the popliteal artery and the posterior capsule of the knee. After negative aspiration, an iPACK block will be performed with 25 mL of 0.25% bupivacaine.
Unilateral iPACK block with 25 mL of mixture 1:1 (0.5 % bupivacaine: 0.9% NaCl)
Other: BiFeS Block
At the end of surgery, all patients will receive an adductor canal block in the recovery unit under sterile conditions and ultrasound guidance using 10 mL of 0.25% bupivacaine. In addition, in the BiFeS block group, with the patient in the supine position and under sterile conditions, a linear ultrasound probe will be used, and a 22G, 100-mm block needle will be advanced to the space between the short head of the biceps femoris muscle and the lateral epicondyle of the femur. After negative aspiration, the BiFeS block will be performed using 25 mL of 0.25% bupivacaine.
Unilateral BiFeS block with 25 mL of mixture 1:1 (0.5 % bupivacaine: 0.9% NaCl)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS Scores
Time Frame: Postoperative 8th-hour
A score of 0 indicates no pain, while a score of 10 represents the worst pain imaginable.
Postoperative 8th-hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Postoperative 2,4,6,12,24th-hour rest and movement
Total opioid consumption
Time Frame: 24 hours after surgery
Patients with a VAS score > 4 will receive 1 mg/kg intravenous tramadol.
24 hours after surgery
Time to first mobilization
Time Frame: 24 hours after surgery
The postoperative hour at which the patients are comfortably mobilized is recorded.
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

September 16, 2026

Study Registration Dates

First Submitted

February 19, 2026

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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