Effect of iPACK and BiFeS Blocks on Quality of Recovery After Total Knee Arthroplasty

NCT07248072 | Recruiting

• 2 other identifiers: B.30.2.ATA.0.01.00/7692025/2
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, randomized, double-blind clinical trial aims to compare the effects of two different posterior knee analgesia techniques-iPACK block (Interspace Between the Popliteal Artery and the Capsule of the posterior Knee) and the Biceps Femoris Short Head (BiFeS) block-when combined with an adductor canal block (ACB) in patients undergoing elective unilateral total knee arthroplasty (TKA). Effective postoperative analgesia is essential for early mobilization, enhanced recovery, and patient satisfaction after TKA. Although ACB provides good anterior knee analgesia while preserving quadriceps strength, additional posterior knee analgesia is often required. The iPACK block is a commonly used technique that targets the posterior knee capsule, whereas the newer BiFeS block aims to provide more selective posterolateral sensory blockade with potentially reduced risk of motor involvement. However, comparative clinical data between these two techniques are limited. The primary objective of this study is to evaluate the difference between the iPACK and BiFeS blocks in terms of Quality of Recovery-15 (QoR-15) scores at 24 hours postoperatively. Secondary objectives include comparisons of postoperative pain scores, opioid consumption, time to first analgesic request, quadriceps and anterior tibialis muscle strength, functional test performance, time to mobilization, active range of motion, and the incidence of adverse events. A total of 74 adult patients scheduled for elective unilateral TKA under spinal anesthesia will be randomized in a 1:1 ratio into two groups: ACB + iPACK block or ACB + BiFeS block. All blocks will be performed under ultrasound guidance by an experienced anesthesiologist. Outcome assessments will be conducted by blinded investigators. The study aims to provide high-quality clinical evidence regarding the effectiveness of the BiFeS block compared to the widely used iPACK technique.

Conditions

Knee Osteoarthritis; Postoperative Pain Management; Total Knee Arthroplasty

Keywords

Total Knee Arthroplasty; Knee Replacement; Adductor Canal Block; iPACK Block; BiFeS Block; Regional Anesthesia; Postoperative Analgesia; QoR-15; Posterior Knee Pain; Ultrasound-Guided Nerve Block

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery-15 (QoR-15) Score at 24 Hours

  The Quality of Recovery-15 (QoR-15) questionnaire is a validated patient-reported outcome measure assessing overall postoperative recovery across domains such as pain, physical comfort, physical independence, psychological support, and emotional well-being. The total score ranges from 0 to 150, with higher scores indicating better recovery. The outcome compares 24-hour QoR-15 scores between the ACB + iPACK group and the ACB + BiFeS group.

  24 hours postoperatively

Secondary Outcomes (10)

• Quality of Recovery-15 (QoR-15) Score at 48 Hours

  48 hours postoperatively

• Pain Scores (VAS) at Rest and During Movement

  2, 4, 8, 12, 24, and 48 hours postoperatively

• Opioid Consumption (Fentanyl PCA)

  24 and 48 hours postoperatively

• Time to First Opioid Request

  Up to 48 hours postoperatively

• Quadriceps and Anterior Tibialis Muscle Strength

  4, 8, 12, 24, and 48 hours postoperatively

Study Arms (2)

Adductor Canal Block + iPACK Block

ACTIVE COMPARATOR

Participants in this arm will receive an ultrasound-guided adductor canal block (ACB) using 15 mL of 0.25% bupivacaine, followed by an iPACK (Interspace Between the Popliteal Artery and the Capsule of the posterior Knee) block with 25 mL of 0.25% bupivacaine. Blocks will be performed under sterile ultrasound guidance by an experienced anesthesiologist who will not participate in postoperative assessments. All patients will receive standardized spinal anesthesia and perioperative analgesia.

Procedure: Adductor Canal Block (ACB) Only; Procedure: IPACK block

Adductor Canal Block + BiFeS Block

EXPERIMENTAL

Participants in this arm will receive an ultrasound-guided adductor canal block (ACB) using 15 mL of 0.25% bupivacaine, followed by a BiFeS (Biceps Femoris Short Head) block performed by injecting 25 mL of 0.25% bupivacaine into the potential space between the femur and the short head of the biceps femoris muscle. Procedures will be performed under sterile ultrasound guidance by an anesthesiologist not involved in postoperative assessments. All participants will receive standardized spinal anesthesia and perioperative analgesia.

Procedure: Adductor Canal Block (ACB) Only; Procedure: BiFeS Block

Interventions

Adductor Canal Block (ACB) Only PROCEDURE

An ultrasound-guided adductor canal block (ACB) will be performed using 15 mL of 0.25% bupivacaine. The probe will be placed on the proximal thigh to visualize the sartorius muscle and femoral artery. The needle will be advanced in-plane into the adductor canal, and correct placement will be confirmed with 2 mL saline before injection. This block aims to provide anterior knee analgesia while preserving quadriceps strength.

Also known as: ACB

Adductor Canal Block + BiFeS Block; Adductor Canal Block + iPACK Block

IPACK block PROCEDURE

The iPACK block will be performed by placing the ultrasound probe at the popliteal region to visualize the popliteal artery and posterior knee capsule. A needle will be advanced in-plane, and 25 mL of 0.25% bupivacaine will be injected between the artery and posterior capsule. This block targets posterior knee pain after total knee arthroplasty without causing motor block.

Also known as: Interspace Between the Popliteal Artery and the Capsule Block, iPACK

Adductor Canal Block + iPACK Block

BiFeS Block PROCEDURE

The BiFeS block will be performed with the ultrasound probe placed laterally to visualize the femur cortex and the long and short heads of the biceps femoris muscle. The needle will be advanced in-plane into the potential space between the femur and the short head of the biceps femoris. After confirming position with 2 mL saline, 25 mL of 0.25% bupivacaine will be injected. This block provides posterolateral knee analgesia with limited motor involvement.

Also known as: Biceps Femoris Short Head Block, BiFeS

Adductor Canal Block + BiFeS Block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years
• Scheduled for elective primary unilateral total knee arthroplasty (TKA)
• Planned spinal anesthesia
• ASA physical status I-III
• Ability to understand study procedures and provide written informed consent

You may not qualify if:

• Known allergy or hypersensitivity to local anesthetics or other study medications
• Coagulopathy or current anticoagulant therapy
• Severe hepatic, renal, or cardiac failure
• History of neuropathic pain
• Infection at the site of proposed nerve block
• Pre-existing neuromuscular disorders in the lower extremities
• Inability to cooperate or refusal to participate in the study
• Pregnancy

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, 25000, Turkey (Türkiye)

RECRUITING

Related Publications (10)

• Kleif J, Waage J, Christensen KB, Gogenur I. Systematic review of the QoR-15 score, a patient- reported outcome measure measuring quality of recovery after surgery and anaesthesia. Br J Anaesth. 2018 Jan;120(1):28-36. doi: 10.1016/j.bja.2017.11.013. Epub 2017 Nov 22.

  PMID: 29397134 BACKGROUND

• 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.

  PMID: 40418224 BACKGROUND

• 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.

  PMID: 40985541 BACKGROUND

• Jaeger P, Zaric D, Fomsgaard JS, Hilsted KL, Bjerregaard J, Gyrn J, Mathiesen O, Larsen TK, Dahl JB. Adductor canal block versus femoral nerve block for analgesia after total knee arthroplasty: a randomized, double-blind study. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):526-32. doi: 10.1097/AAP.0000000000000015.

  PMID: 24121608 BACKGROUND

• Kehlet H, Dahl JB. Anaesthesia, surgery, and challenges in postoperative recovery. Lancet. 2003 Dec 6;362(9399):1921-8. doi: 10.1016/S0140-6736(03)14966-5.

  PMID: 14667752 BACKGROUND

• Grosu I, Lavand'homme P, Thienpont E. Pain after knee arthroplasty: an unresolved issue. Knee Surg Sports Traumatol Arthrosc. 2014 Aug;22(8):1744-58. doi: 10.1007/s00167-013-2750-2. Epub 2013 Nov 8.

  PMID: 24201900 BACKGROUND

• Carr AJ, Robertsson O, Graves S, Price AJ, Arden NK, Judge A, Beard DJ. Knee replacement. Lancet. 2012 Apr 7;379(9823):1331-40. doi: 10.1016/S0140-6736(11)60752-6. Epub 2012 Mar 6.

  PMID: 22398175 BACKGROUND

• Myles PS, Myles DB, Galagher W, Chew C, MacDonald N, Dennis A. Minimal Clinically Important Difference for Three Quality of Recovery Scales. Anesthesiology. 2016 Jul;125(1):39-45. doi: 10.1097/ALN.0000000000001158.

  PMID: 27159009 RESULT

• Kertkiatkachorn W, Kampitak W, Tanavalee A, Ngarmukos S. Adductor Canal Block Combined With iPACK (Interspace Between the Popliteal Artery and the Capsule of the Posterior Knee) Block vs Periarticular Injection for Analgesia After Total Knee Arthroplasty: A Randomized Noninferiority Trial. J Arthroplasty. 2021 Jan;36(1):122-129.e1. doi: 10.1016/j.arth.2020.06.086. Epub 2020 Jul 2.

  PMID: 32694032 RESULT

• Abdullah MA, Abu Elyazed MM, Mostafa SF. The Interspace Between Popliteal Artery and Posterior Capsule of the Knee (IPACK) Block in Knee Arthroplasty: A Prospective Randomized Trial. Pain Physician. 2022 May;25(3):E427-E433.

  PMID: 35652772 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Single Person; Dental Occlusion

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors; Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Ahmet Murat Yayık, Principal Investigator

  Ataturk University Department of Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

• Mehmet Akif YILMAZ, assistant doctor

  Ataturk University Department of Anesthesiology and Reanimation

  STUDY DIRECTOR

Central Study Contacts

Ahmet Murat Yayık, Associate Professor

CONTACT

+90-554-425-92-87; m_yayik@hotmail.com

Mehmet Akif Yılmaz, assistant doctor

CONTACT

+90-534-653-35-39; mehmetakifyilmaz025@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will remain blinded to group allocation. The anesthesiologist performing the block procedures will not participate in postoperative assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Ahmet Murat Yayık

Model Details: Two-arm, randomized, parallel-group design comparing iPACK and BiFeS blocks in combination with an adductor canal block.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: December 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 2, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)