iPACK Block vs. Periarticular Infiltration for TKA Pain Control

NCT07267650 | Not Yet Recruiting

• 1 other identifier: ANES-TKA-2025-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to retrospectively compare two different multimodal analgesic techniques for pain management after total knee arthroplasty (TKA). The primary purpose is to evaluate whether a combination of two specific nerve blocks administered by an anesthesiologist (Femoral Triangle Block + iPACK block) resulted in superior postoperative pain control compared to a hybrid combination of a nerve block and a local infiltration administered by the surgeon (FTB + Periarticular Infiltration \[PAI\]). The hypothesis is that the FTB + iPACK combination is associated with a significant reduction in Numeric Rating Scale (NRS) pain scores with movement at 24 hours postoperatively. This is a retrospective, observational cohort study conducted at a single center, involving medical records of patients who underwent primary unilateral TKA. Data from patients who received either FTB + iPACK or FTB + PAI as part of their standard clinical care will be extracted and analyzed retrospectively.

Conditions

Pain, Postoperative; Osteoarthritis, Knee / Osteoarthritis, Hip

Keywords

Total Knee Arthroplasty; TKA; Postoperative Pain; Pain Management; Analgesia; Nerve Block; Femoral Triangle Block; FTB; iPACK block; Local Infiltration Analgesia; Timed Up and Go Test; Straight Leg Raise; Periarticular Infiltration; Regional Anesthesia

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Score with Movement at 24 Hours

  Pain assessed via Numeric Rating Scale (NRS) during active movement (e.g., active knee flexion or straight leg raise). Scale: 0 (no pain) to 10 (worst pain imaginable).

  24 and 48. hours postoperatively

Secondary Outcomes (6)

• Postoperative Pain Scores (Time-Course)

  Assessed at 6, 12, and 24 hours postoperatively

• Time to First Rescue Analgesia

  First 24 postoperative hours

• Time Up to Go Test

  Assessed at 24 hours

• Straight Leg Raise

  Postoperative 24. hour

• Knee Range of Motion (ROM)

  Baseline (Preoperative) and 24 hours postoperatively

Study Arms (2)

FTB + iPACK Group

Patients who underwent primary unilateral TKA and received FTB + iPACK block as part of standard clinical care.

FTB + PAI Group

Patients who underwent primary unilateral TKA and received FTB + PAI as part of standard clinical care.

Interventions

FTB

Sham Intervention 1 (Surgeon)

PAI (Surgeon)

Bupivacaine %0.25 (isobaric)

Bupivacaine + Adrenaline + Methylprednisolone + Cefazoline

Normal Saline (0.9% NaCl)

IPACK block

Sham Intervention 2 (Anesthesiologist)

Eligibility Criteria

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

Study Population

The study population consists of adult patients who underwent elective, primary, unilateral total knee arthroplasty (TKA) under spinal anesthesia at Turgutlu State Hospital. Patient records and institutional registries will be reviewed retrospectively to identify eligible cases managed within a specific operational period (e.g., between December 2025 and May 2026). The cohort includes patients who received either an ultrasound-guided Femoral Triangle Block combined with an iPACK block or a hybrid combination of Femoral Triangle Block and surgeon-administered Periarticular Infiltration for postoperative analgesia as part of standard clinical care.

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status II-III.
• Scheduled for elective, primary, unilateral total knee arthroplasty for osteoarthritis.
• Able to provide written informed consent.

You may not qualify if:

• Patient refusal to participate or contraindication to regional anesthesia.
• Known allergy to any study medications (local anesthetics, NSAIDs, tramadol, morphine, paracetamol).
• History of chronic opioid use (defined as daily use for \>3 months)
• Pre-existing peripheral neuropathy in the operative limb.
• Severe renal or hepatic insufficiency.
• Cognitive impairment preventing the use of pain scales or questionnaires.
• Revision or bilateral knee arthroplasty.

Sponsors & Collaborators

• Turgutlu State Hospital: lead

Study Sites (1)

Turgutlu State Hospital+

Manisa, Manisa, 45000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Osteoarthritis; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Aslan

  Turgutlu State Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Celil M Aslan, Medical Doctor

CONTACT

+90505534900; mcaslan@outlook.com.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: December 5, 2025
• Study Start: May 1, 2026
• Primary Completion: May 1, 2026
• Study Completion: August 1, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR

Locations

TU (1)