Comparison of BiFeS + ACB and IPACK + ACB Block Combinations for Postoperative Pain After Total Knee Arthroplasty

NCT07231692 | Completed

• 1 other identifier: BiFeS2025/2462
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational study will compare the postoperative analgesic efficacy of two multimodal regional anesthesia combinations routinely used after total knee arthroplasty (TKA) performed under spinal anesthesia. The study will observe patient groups who receive, as part of standard clinical practice, either the Biceps Femoris Short Head (BiFeS) block combined with the Adductor Canal Block (ACB) or the Interspace Between the Popliteal Artery and the Capsule of the Knee (IPACK) block combined with the Adductor Canal Block (ACB). The research team will not assign, perform, or direct any blocks; all regional anesthesia procedures will be administered independently by anesthesiologists experienced in ultrasound-guided regional anesthesia as part of routine care. Postoperative pain will be observed and documented using the Numeric Rating Scale (NRS) at multiple time points within the first 24 hours. Opioid consumption will be recorded based on intravenous patient-controlled analgesia (PCA) data, and the need for rescue analgesia will be noted. Additional postoperative observations will include functional recovery, quality of recovery scores, and the incidence of adverse events. Postoperative pain will be evaluated using the Numeric Rating Scale (NRS) at multiple time points within the first 24 hours. Opioid consumption will be recorded through intravenous patient-controlled analgesia (PCA), and the need for rescue analgesia will be assessed. Additional postoperative observations will include functional recovery, quality of recovery scores, and the incidence of adverse events.

Conditions

Pain After Total Knee Arthroplasty; Pain, Postoperative; Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

• Cumulative opioid consumption in the first 24 hours after surgery

  Morphine consumption in the first 24 hours after surgery will be measured. Patients will be able to request opioids via a PCA device when their NRS score is ≥ 4.

  Postoperative day 1

Secondary Outcomes (12)

• Cumulative opioid consumption in the first 12 hours after surgery

  postoperative 12th hour

• Postoperative pain scores

  Postoperative day 1

• Block performance time

  İntraoperative period

• The Quality of Recovery-15 (QoR-15) score

  24 hours postoperatively and postoperative day 2-4

• The postoperative nausea and vomiting (PONV) scores and the number of patients requiring antiemetic medication

  Postoperative day 1

Study Arms (2)

Group BiFeS

Adductor canal block and BiFeS block ( 15 ml %0.25 bupivacaine and 25 ml %0.25 bupivacaine) + IV morphine patient-controlled analgesia (PCA)

Group IPACK

Adductor canal block and IPACK block ( 15 ml %0.25 bupivacaine and 25 ml %0.25 bupivacaine) + IV morphine patient-controlled analgesia (PCA)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will include adult patients aged 18-80 years undergoing elective unilateral total knee arthroplasty (TKA) under spinal anesthesia at Karabük Training and Research Hospital. Eligible participants will have ASA physical status I-III and be capable of using patient-controlled analgesia (PCA). Patients will be prospectively observed as part of routine multimodal analgesia including either BiFeS + ACB or IPACK + ACB block combinations for postoperative pain management.

You may qualify if:

• Adults aged 18-80 years scheduled for elective unilateral total knee arthroplasty (TKA) under spinal anesthesia
• ASA physical status I-III
• Eligible for and capable of using patient-controlled analgesia (PCA)
• Provided written informed consent

You may not qualify if:

• Chronic opioid use for more than four weeks before surgery
• Presence of chronic pain conditions (e.g., migraine, fibromyalgia)
• History of alcohol or drug abuse
• Known allergy or hypersensitivity to local anesthetics or opioids
• Severe organ dysfunction (e.g., significant hepatic or renal disease)
• Revision or bilateral knee arthroplasty
• Contraindications to regional anesthesia
• Preexisting neuropathy or prior femoral vascular surgery on the operated side.
• Infection near the injection site (e.g., osteomyelitis, septic joint).
• Contraindication to spinal anesthesia (e.g., refusal, coagulopathy, use of anticoagulants or antiplatelet agents) or inability to understand NRS.
• Severe psychiatric or cognitive disorders (e.g., psychosis, dementia) that prevent cooperation or pain assessment
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Karabuk University: lead

Study Sites (1)

Karabuk Training and Research Hospital, Department of Anesthesiology and Reanimation

Karabük, Karabük Province, 78200, Turkey (Türkiye)

Location

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

• Elif Sarikaya Özel, M.D.

  Karabuk Training and Research Hospital, Department of Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Principal Investigator

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: October 15, 2025
• Primary Completion: January 30, 2026
• Study Completion: January 31, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)