Postoperative PainNCT07433803
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 study testing IPACK block and BiFeS Block in people with Postoperative Pain, run by Soma State Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- IPACK block and BiFeS Block
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2026to 16 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for unilateral total knee arthroplasty
- Patients aged between 18 and 75 years
- Patients with ASA physical status I-III
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Soma State Hospital
Manisa, Soma, 45500
Meltem Savas Ozdemir, MD, +905557331143, drmeltemsavas@gmail.com
Pelin Dilsiz Eker, MD
About this study
Official title: 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).
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- IPACK block, BiFeS Block
- Keywords
- BiFeS Block, iPACK Block, Postoperative pain scores, Time to mobilization, Total opioid consumption
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPACK blockProcedure or surgery
Unilateral iPACK block with 25 mL of mixture 1:1 (0.5 % bupivacaine: 0.9% NaCl)
BiFeS BlockProcedure or surgery
Unilateral BiFeS block with 25 mL of mixture 1:1 (0.5 % bupivacaine: 0.9% NaCl)
| Study group | Role | What they receive |
|---|---|---|
| iPACK Block | Active comparator | 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. Receives: Procedure: IPACK block |
| BiFeS Block | Other | 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. Receives: Procedure: BiFeS Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS Scores
A score of 0 indicates no pain, while a score of 10 represents the worst pain imaginable.
Measured: Postoperative 8th-hour
Secondary outcomes (3)
VAS Scores
A score of 0 indicates no pain, while a score of 10 represents the worst pain imaginable.
Measured: Postoperative 2,4,6,12,24th-hour rest and movement
Total opioid consumption
Patients with a VAS score > 4 will receive 1 mg/kg intravenous tramadol.
Measured: 24 hours after surgery
Time to first mobilization
The postoperative hour at which the patients are comfortably mobilized is recorded.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start15 May 2026 (estimated)
- Primary completion15 Sep 2026 (estimated)
- Study completion16 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, double-blind, non-inferiority clinical trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soma State Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Meltem Savas Ozdemir, Soma State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433803
- Sponsor's protocol ID
- BiFeS2026
- Status last verified
- Apr 2026
- First submitted
- 19 Feb 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40418224Sarikaya 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.
PubMed 40985541Akesen 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.
PubMed 33847575
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07433803
- Acronym / sponsor ID
- BiFeS2026
- Conditions
- Postoperative Pain
- Keywords
- BiFeS Block, iPACK Block, Postoperative pain scores, Time to mobilization, Total opioid consumption
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Soma State HospitalOther government
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 16 Sep 2026 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, double-blind, non-inferiority clinical trial.
| Arm | Type | Receives |
|---|---|---|
| iPACK Block | Active comparator | Procedure: IPACK blockAt 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. |
| BiFeS Block | Other | Procedure: BiFeS BlockAt 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for unilateral total knee arthroplasty
- Patients aged between 18 and 75 years
- Patients with ASA physical status I-III
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPACK blockUnilateral iPACK block with 25 mL of mixture 1:1 (0.5 % bupivacaine: 0.9% NaCl) | Procedure or surgery | iPACK Block |
| BiFeS BlockUnilateral BiFeS block with 25 mL of mixture 1:1 (0.5 % bupivacaine: 0.9% NaCl) | Procedure or surgery | BiFeS Block |
Primary outcome
VAS Scores
Time frame: Postoperative 8th-hour
A score of 0 indicates no pain, while a score of 10 represents the worst pain imaginable.
3 secondary outcomes
VAS Scores
Time frame: Postoperative 2,4,6,12,24th-hour rest and movement
Total opioid consumption
Time frame: 24 hours after surgery
Time to first mobilization
Time frame: 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Results publication: PubMed 40418224Kilicaslan 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.
- Results publication: PubMed 40985541Sarikaya 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.
- Results publication: PubMed 33847575Akesen 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.
- Ultrasound-guided biceps femoris short head block: a novel regional anesthesia technique for the posterolateral kneeLink provided by the sponsor.
- 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 studyLink provided by the sponsor.
- Ultrasound-Guided Biceps Femoris Short Head Block for Posterolateral Knee Analgesia After Total Knee Arthroplasty: A Case ReportLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPACK block and BiFeS Block in people with Postoperative Pain, run by Soma State Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meltem Savas Ozdemir, MD (+905557331143, drmeltemsavas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS Scores (time frame: Postoperative 8th-hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07433803, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.