- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Meltem Savas Ozdemir, MD
- Phone Number: +905557331143
- Email: drmeltemsavas@gmail.com
Study Locations
-
-
Soma
-
Manisa, Soma, Turkey (Türkiye), 45500
- Soma State Hospital
-
Contact:
- Meltem Savas Ozdemir, MD
- Phone Number: +905557331143
- Email: drmeltemsavas@gmail.com
-
Sub-Investigator:
- Pelin Dilsiz Eker, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Publications and helpful links
General Publications
- Kilicaslan A, Tulgar S, Ahiskalioglu A, Aycan IO, Kekec AF, Arici AG, Kilic G, Sindel M. Ultrasound-guided biceps femoris short head block: a novel regional anesthesia technique for the posterolateral knee. Pain Med. 2025 Nov 1;26(11):726-732. doi: 10.1093/pm/pnaf068.
- Sarikaya Ozel E, Taflan MG. Ultrasound-Guided Biceps Femoris Short Head Block for Posterolateral Knee Analgesia After Total Knee Arthroplasty: A Case Report. A A Pract. 2025 Sep 23;19(9):e02060. doi: 10.1213/XAA.0000000000002060. eCollection 2025 Sep 1.
- Akesen S, Akesen B, Atici T, Gurbet A, Ermutlu C, Ozyalcin A. Comparison of efficacy between the genicular nerve block and the popliteal artery and the capsule of the posterior knee (IPACK) block for total knee replacement surgery: A prospective randomized controlled study. Acta Orthop Traumatol Turc. 2021 Mar;55(2):134-140. doi: 10.5152/j.aott.2021.20187.
Helpful Links
- Ultrasound-guided biceps femoris short head block: a novel regional anesthesia technique for the posterolateral knee
- Comparison of efficacy between the genicular nerve block and the popliteal artery and the capsule of the posterior knee (IPACK) block for total knee replacement surgery: A prospective randomized controlled study
- Ultrasound-Guided Biceps Femoris Short Head Block for Posterolateral Knee Analgesia After Total Knee Arthroplasty: A Case Report
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BiFeS2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Postoperative Pain
-
National and Kapodistrian University of AthensCompletedPostoperative Pain, Acute | Postoperative Pain, Chronic | Postoperative Pain After Thoracic SurgeryGreece
-
Second Affiliated Hospital, School of Medicine,...Not yet recruitingPostoperative Pain | Postoperative Pain Management | Postoperative Pain in Orthopaedics
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Aydin Adnan Menderes UniversityCompleted
-
Aydin Adnan Menderes UniversityCompletedAcute Postoperative Pain | Chronic Postoperative PainTurkey
-
Children's National Research InstituteVentureWellRecruitingPostoperative Pain | Acute Pain | Acute Pain, PostoperativeUnited States
-
University of MalayaActive, not recruitingPostoperative Pain | Postoperative Pain ManagementMalaysia
-
Maimonides Medical CenterCompletedPOSTOPERATIVE PAINUnited States
-
University Hospital, AntwerpUnknown
Clinical Trials on IPACK block
-
Ain Shams UniversityNot yet recruitingFunctional Recovery | Adductor Canal Block | Total Knee Replacement Surgery
-
Dr Abdurrahman Yurtaslan Ankara Oncology Training...CompletedPain, Postoperative | Pain Management | Arthropathy of Knee | Early AmbulationTurkey (Türkiye)
-
Minia UniversityNot yet recruitingPostoperative AnalgesiaEgypt
-
Konya Beyhekim Training and Research HospitalNot yet recruitingTotal Knee Arthroplasty | Adductor Canal Block | IPACK Block Multimodal Analgesia | Genicular Nerves Block
-
Tanta UniversityCompleted
-
Fayoum University HospitalNot yet recruiting
-
Luzerner KantonsspitalRecruitingJoint Diseases | Joint PainSwitzerland
-
Erzincan UniversityRecruitingTotal Knee Arthroplasty | Post Operative AnalgesiaTurkey (Türkiye)
-
Ziekenhuis Oost-LimburgCompletedAnalgesia | Total Knee ArthroplastyBelgium
-
Ain Shams UniversityEnrolling by invitation