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Postoperative PainNCT07561333

Comparing ACB+IPACK and ACB+BiFeS Block Combinations for Analgesia in Total Knee Arthroplasty

A study testing ACB+IPACK Group and ACB+BiFeS Group in people with Postoperative Pain and Total Knee Arthroplasty, run by Hitit University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Total knee arthroplasty (TKA) is associated with severe postoperative pain that delays mobilization, prolongs hospital stay, and reduces patient satisfaction. Regional analgesia techniques have gained prominence due to their opioid-sparing effects and favorable complication profiles compared to general anesthesia. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Postoperative Pain, Total Knee Arthroplasty
What is being tested?
ACB+IPACK Group and ACB+BiFeS Group
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Oct 2025to 1 Nov 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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Scheduled for primary total knee arthroplasty surgery
  • ASA physical status classification I-III
  • Hemodynamically stable
  • Age ≥ 18 years and ≤ 80 years
  • BMI ≤ 35 kg/m²
  • Signed written informed consent form

Who cannot join

  • Revision total knee arthroplasty surgery
  • Simultaneous bilateral total knee arthroplasty
  • BMI > 40 kg/m²
  • ASA physical status classification 4-5
  • Inability to perform NRS pain scoring
  • Known allergy to local anesthetics
Show all 19Show fewer
  • Pregnancy or breastfeeding
  • Age < 18 or > 80 years
  • Uncontrolled anxiety disorder
  • Alcohol or drug dependency
  • Neuromuscular disease or peripheral nerve disease
  • High-dose opioid use within 3 days prior to surgery
  • Widespread chronic pain syndrome
  • Diabetes mellitus
  • Hepatic or renal insufficiency
  • Coagulation disorders
  • Current use of anticoagulant medications
  • Infection at the peripheral nerve block needle insertion site
  • 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.

Merve YAGIZ BALDIRAN, MD contact

+905432835144

merveyagiz-1@hotmail.com

Arzu AKDAGLI EKICI, MD contact

+905057516387

akekici@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Hitit University

    Çorum, Centre, 19100

    Guvenc DOGAN, MD, +905324025208, guvencdogan@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Analgesic Efficacy of Infiltration Between the Popliteal Artery and Capsule of the Knee (IPACK) Versus Biceps Femoris Short Head Block Combined With Adductor Canal Block in Total Knee Arthroplasty

Total knee arthroplasty (TKA) is associated with severe postoperative pain that delays mobilization, prolongs hospital stay, and reduces patient satisfaction. Regional analgesia techniques have gained prominence due to their opioid-sparing effects and favorable complication profiles compared to general anesthesia. While adductor canal block (ACB) effectively manages anterior knee pain with preserved motor function, posterior knee pain remains a challenge. IPACK (Infiltration between the Popliteal Artery and Capsule of the Knee) and the Biceps Femoris Short Head (BiFeS) block are techniques targeting posterior capsule innervation without causing motor block.This prospective study aims to compare the postoperative analgesic efficacy of ultrasound-guided ACB+IPACK versus ACB+BiFeS block combinations in patients undergoing TKA under spinal anesthesia. Patients (ASA I-III, age 18-80, BMI ≤35) will be randomized into two groups (n=39 each). Primary outcomes include NRS pain scores at rest and on movement, and opioid consumption at 0, 1, 3, 6, 12, 18, and 24 hours postoperatively. Secondary outcomes include time to first mobilization, motor block incidence, quadriceps muscle strength assessment, PONV, and quality of recovery (QoR-15).

Read the detailed description

Total knee arthroplasty (TKA) is a widely performed surgical intervention for end-stage knee osteoarthritis and other debilitating knee conditions. Severe postoperative pain following TKA delays early mobilization and rehabilitation, prolongs hospital stay, reduces patient satisfaction, and increases complication risk. Regional analgesia techniques have emerged as the preferred approach due to their ability to reduce opioid consumption, minimize opioid-related side effects (nausea, vomiting, respiratory depression, constipation), and preserve motor function. Ultrasound guidance further improves block success rates and reduces the local anesthetic volume required.

Optimal postoperative analgesia in TKA requires consideration of the complex innervation of the knee joint. The anterior compartment is primarily innervated by branches of the femoral nerve, while the posterior capsule is supplied by branches of the sciatic nerve. Adductor Canal Block (ACB) reduces anterior knee pain by blocking the saphenous nerve and branches of the obturator nerve while preserving quadriceps strength compared to femoral nerve block; however, it may be insufficient alone for controlling posterior capsule pain. The IPACK block (Infiltration between the Popliteal Artery and Capsule of the Knee) addresses posterior knee pain by depositing local anesthetic between the popliteal artery and knee capsule, blocking sensory innervation of the posterior capsule without causing motor block. The Biceps Femoris Short Head (BiFeS) block is a novel ultrasound-guided technique targeting nerve branches innervating the posterolateral knee capsule, aiming to reduce posterior knee pain while preserving motor function.

Study Design:

This is a prospective, randomized, observational study conducted at Hitit University Erol Olçok Training and Research Hospital. Patients will be randomized into two groups by an investigator not directly involved in the study:

Group P (ACB+IPACK): Adductor canal block combined with IPACK block (n=39) Group B (ACB+BiFeS): Adductor canal block combined with Biceps Femoris Short Head block (n=39)

Inclusion Criteria:

Patients scheduled for TKA surgery, ASA physical status I-III, hemodynamically stable, aged 18 years or older, BMI ≤35 kg/m², and who have signed the informed consent form.

Exclusion Criteria:

Revision TKA surgery, simultaneous bilateral TKA, BMI >40 kg/m², ASA 4-5, inability to perform NRS pain scoring, allergy to local anesthetics, pregnancy or breastfeeding, age <18 or >80 years, uncontrolled anxiety, alcohol or drug dependency, neuromuscular or peripheral nerve disease, high-dose opioid use within 3 days prior to surgery, widespread chronic pain, diabetes mellitus, hepatic or renal insufficiency, coagulation disorders, anticoagulant use, or infection at the block needle insertion site.

Anesthetic and Block Technique:

All patients will receive standard anesthesia monitoring (non-invasive arterial blood pressure, heart rate, ECG, pulse oximetry) and IV access via a 20G catheter. Quadriceps muscle strength will be recorded before block application using the Medical Research Council (MRC) scale. Premedication will consist of midazolam 0.07-0.15 mg/kg and fentanyl 0.5 mcg/kg IV, with supplemental oxygen via face mask. All block procedures will be performed under standard sterile conditions.

Adductor Canal Block (ACB): With the patient in supine position and the hip in slight external rotation, a linear ultrasound probe is placed vertically at the midpoint between the patella and inguinal crease on the medial thigh. The femoral artery is identified in short-axis view and tracked medially until it appears deep to the sartorius muscle. A 10 cm peripheral nerve block needle is advanced in-plane, and 15 mL of 0.25% bupivacaine is injected around the femoral artery deep to the sartorius muscle, with negative aspiration confirmed every 5 mL.

IPACK Block: With the patient in prone position, a linear probe is placed over the popliteal crease to visualize the space between the popliteal artery and femoral condyles. A 10 cm needle is inserted in-plane from medial to lateral. After negative aspiration and hydrodissection with 1-2 mL of local anesthetic to confirm correct placement, 25 mL of 0.25% bupivacaine is injected with negative aspiration confirmed every 5 mL, distributed evenly between the initial needle tip position (2 cm lateral to the popliteal artery) and the posteromedial border of the femur.

BiFeS Block: With the patient in supine position and the knee in slight flexion, a linear ultrasound probe is placed transversely on the lateral surface of the distal third of the thigh. The biceps femoris short head muscle is identified along the linea aspera of the femur. The needle insertion point is determined at the level of the lateral supracondylar line of the femur, approximately 6-8 cm proximal to the lateral femoral epicondyle. A 10 cm needle is advanced in-plane from lateral to medial, targeting the plane between the biceps femoris short head and the lateral femoral cortex. After hydrodissection with 1-2 mL to confirm correct plane, 25 mL of 0.25% bupivacaine is injected slowly with negative aspiration confirmed every 5 mL.

Following block application, spinal anesthesia will be performed with the patient in sitting position. The L4-L5 interspace will be identified, and 12.5 mg of 0.5% hyperbaric bupivacaine will be administered intrathecally via a 25G spinal needle over 1 minute. Surgery will commence when Bromage score reaches 3 and sensory block level reaches T10.

Postoperative Management and Outcome Measures:

Postoperative analgesia will be standardized for all patients: IV paracetamol 1g every 8 hours and patient-controlled analgesia (PCA) with tramadol (bolus dose 10 mg, lockout interval 20 minutes, no basal infusion, maximum 400 mg/day). Rescue analgesia with IV fentanyl 25 mcg will be administered for NRS ≥4, with total dose recorded.

Pain assessment using the Numeric Rating Scale (NRS, 0-10) will be performed at rest and during active movement (sitting up from bed) at postoperative hours 0, 1, 3, 6, 12, 18, and 24 by a blinded nurse or pain monitoring team.

Quadriceps muscle strength will be assessed at postoperative hours 2 and 24 using the MRC scale (0-5), with the contralateral unoperated leg serving as the control reference. A score of 4 or above will be considered indicative of preserved motor function.

Additional outcomes recorded will include tramadol consumption at 0-1, 1-12, 12-24, and total 24 hours; time to first opioid requirement; PONV severity (PONV scale 1-4) with ondansetron 4 mg IV administered for PONV score ≥2; vital signs at postoperative hours 0, 1, 3, 6, 12, 18, and 24; Quality of Recovery (QoR-15) scores preoperatively and at postoperative hour 24; time to first oral intake, flatus, and defecation; and time to first assisted mobilization.

Study Termination Criteria:

NRS >7 for 4 consecutive hours despite tramadol therapy, inability to perform NRS assessment, or incomplete surgery.

Being tested
ACB+IPACK Group, ACB+BiFeS Group
Keywords
Total knee arthroplasty, Regional anesthesia
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACB+IPACK GroupProcedure or surgery

    Patients receiving ultrasound-guided adductor canal block (15 mL of 0.25% bupivacaine) combined with IPACK block (25 mL of 0.25% bupivacaine) for postoperative analgesia following total knee arthroplasty under spinal anesthesia.

  • ACB+BiFeS GroupProcedure or surgery

    Patients receiving ultrasound-guided adductor canal block (15 mL of 0.25% bupivacaine) combined with Biceps Femoris Short Head block (25 mL of 0.25% bupivacaine) for postoperative analgesia following total knee arthroplasty under spinal anesthesia.

Study groups in NCT07561333
Study groupRoleWhat they receive
ACB+IPACK GroupActive comparatorACB+IPACK Group: Patients receiving ultrasound-guided adductor canal block (15 mL of 0.25% bupivacaine) combined with IPACK block (25 mL of 0.25% bupivacaine) for postoperative analgesia following total knee arthroplasty under spinal anesthesia.
Receives: Procedure: ACB+IPACK Group
ACB+BiFeS GroupActive comparatorACB+BiFeS Group: Patients receiving ultrasound-guided adductor canal block (15 mL of 0.25% bupivacaine) combined with Biceps Femoris Short Head block (25 mL of 0.25% bupivacaine) for postoperative analgesia following total knee arthroplasty under spinal anesthesia.
Receives: Procedure: ACB+BiFeS Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative 24-hour Opioid Consumption (Morphine Equivalent Dose)

    Total postoperative opioid consumption will be calculated as morphine-equivalent dose (mg) over the first 24 hours. Tramadol administered via patient-controlled analgesia (PCA) and rescue fentanyl (25 mcg IV for NRS ≥4) will be recorded and converted into morphine equivalents. The cumulative total opioid consumption at 24 hours will be reported.

    Measured: 24 hours postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2026
  2. Study start1 Oct 2025
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion1 Nov 2026 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two parallel groups of patients undergoing total knee arthroplasty under spinal anesthesia will be randomized to receive either ultrasound-guided ACB+IPACK (Group P, n=39) or ACB+BiFeS (Group B, n=39) for postoperative analgesia.
Masking
Single blind
Who is masked
Participant
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07561333
Sponsor's protocol ID
2025-162
Status last verified
Apr 2026
First submitted
20 Apr 2026
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing ACB+IPACK Group and ACB+BiFeS Group in people with Postoperative Pain and Total Knee Arthroplasty, run by Hitit University 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 6 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 1 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 Merve YAGIZ BALDIRAN, MD (+905432835144, merveyagiz-1@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative 24-hour Opioid Consumption (Morphine Equivalent Dose) (time frame: 24 hours postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 1 May 2026.

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