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

NCT07561333 | Recruiting

• 1 other identifier: 2025-162
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Postoperative Pain; Total Knee Arthroplasty

Keywords

Total knee arthroplasty; Regional anesthesia

Outcome Measures

Primary Outcomes (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.

  24 hours postoperative

Study Arms (2)

ACB+IPACK Group

ACTIVE COMPARATOR

ACB+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.

Procedure: ACB+IPACK Group

ACB+BiFeS Group

ACTIVE COMPARATOR

ACB+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.

Procedure: ACB+BiFeS Group

Interventions

ACB+IPACK Group PROCEDURE

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+IPACK Group

ACB+BiFeS Group PROCEDURE

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.

ACB+BiFeS Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hitit University: lead

Study Sites (1)

Hitit University

Çorum, Centre, 19100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Guvenc DOGAN, MD

  Hitit University

  STUDY CHAIR

Central Study Contacts

Merve YAGIZ BALDIRAN, MD

CONTACT

+905432835144; merveyagiz-1@hotmail.com

Arzu AKDAGLI EKICI, MD

CONTACT

+905057516387; akekici@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: May 1, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

TU (1)