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NCT Number: NCT07267650

iPACK Block vs. Periarticular Infiltration for TKA Pain Control

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.

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Key information

About this study

Total knee arthroplasty (TKA) is a highly successful procedure for end-stage knee osteoarthritis but is associated with significant postoperative pain. Effective pain management is crucial for facilitating early rehabilitation and improving patient comfort. Modern pain management relies on multimodal, opioid-sparing protocols that often include motor-sparing regional anesthesia techniques like the femoral triangle block (FTB).

While FTB provides excellent analgesia for the anterior part of the knee, pain originating from the posterior knee capsule remains a significant challenge. This posterior pain is commonly managed either by the surgeon through a diffuse periarticular infiltration (PAI) of a local anesthetic cocktail or by the anesthesiologist through a targeted, ultrasound-guided block of the posterior capsule known as the iPACK block.

It is currently unclear whether a fully anesthesiologist-driven, neuroanatomically targeted approach (FTB + iPACK) offers superior clinical outcomes compared to a hybrid approach involving both the anesthesiologist and the surgeon (FTB + PAI). This retrospective study is designed to compare the clinical efficacy of these two advanced analgesic combinations by reviewing institutional patient registries. All included patients had previously received a standardized spinal anesthetic (3 mL of 0.5% heavy bupivacaine) followed by either of the regional analgesia protocols. The study evaluates postoperative pain control, measured primarily by Numeric Rating Scale (NRS) pain scores at 24 hours. Secondary outcomes include total rescue analgesic (tramadol) consumption, functional recovery (Timed Up and Go test and Straight Leg Raise test), and knee range of motion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Postoperative Pain Score with Movement at 24 Hours

    Time frame: 24 and 48. hours postoperatively

    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).

Secondary outcomes

  1. Postoperative Pain Scores (Time-Course)

    Time frame: Assessed at 6, 12, and 24 hours postoperatively

    Numeric Rating Scale (NRS) for pain (0-10) assessed at rest and with movement.

  2. Time to First Rescue Analgesia

    Time frame: First 24 postoperative hours

    Time (in minutes) from the end of surgery to the first patient request for rescue tramadol.

  3. Time Up to Go Test

    Time frame: Assessed at 24 hours

    The time taken (in seconds) for the participant to stand up from a standard armchair, walk a distance of 3 meters, turn, walk back to the chair, and sit down. Lower values indicate better functional mobility.

  4. Straight Leg Raise

    Time frame: Postoperative 24. hour

    Assessment of active quadriceps motor function. Defined as the participant's ability to actively lift the operated leg off the bed with the knee fully extended (straight). This will be assessed as a binary outcome (Success = Able to lift unassisted / Failure = Unable to lift).

  5. Knee Range of Motion (ROM)

    Time frame: Baseline (Preoperative) and 24 hours postoperatively

    Active knee flexion (in degrees)

  6. Incidence of Adverse Events

    Time frame: First 48 hours.

    Incidence of postoperative nausea/vomiting (PONV) and pruritus.

Study contacts

Contact information is provided by the study sponsor or research team.

Celil M Aslan, Medical Doctor

CONTACT

[email protected]

+90505534900

Sponsors and collaborators

Lead sponsor

Turgutlu State Hospital

Other

Registry information

Official study title

Postoperative Analgesic Outcomes of iPACK Block Versus Periarticular Infiltration in Total Knee Arthroplasty: A Retrospective Cohort Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2025
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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