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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07433803
Enrollment
100
Registered
2026-02-25
Start date
2026-03-15
Completion date
2026-09-16
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

BiFeS Block, iPACK Block, Postoperative pain scores, Time to mobilization, Total opioid consumption

Brief summary

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).

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.

Interventions

PROCEDUREIPACK block

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

PROCEDUREBiFeS Block

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

Sponsors

Soma State Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Intervention model description

This is a prospective, randomized, double-blind, non-inferiority clinical trial.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
VAS ScoresPostoperative 8th-hourA score of 0 indicates no pain, while a score of 10 represents the worst pain imaginable.

Secondary

MeasureTime frameDescription
VAS ScoresPostoperative 2,4,6,12,24th-hour rest and movementA score of 0 indicates no pain, while a score of 10 represents the worst pain imaginable.
Total opioid consumption24 hours after surgeryPatients with a VAS score \> 4 will receive 1 mg/kg intravenous tramadol.
Time to first mobilization24 hours after surgeryThe postoperative hour at which the patients are comfortably mobilized is recorded.

Countries

Turkey (Türkiye)

Contacts

CONTACTMeltem Savas Ozdemir, MD
drmeltemsavas@gmail.com+905557331143

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026