iPACK Block vs. Periarticular Infiltration for TKA Pain Control

NCT07267650 | Not Yet Recruiting

• 1 other identifier: ANES-TKA-2025-001
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to compare two different multimodal analgesic techniques for pain management after total knee arthroplasty (TKA). The primary purpose is to determine if a combination of two specific nerve blocks administered by an anesthesiologist (Femoral Triangle Block + iPACK block) results in superior pain control compared to a 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 will lead to a significant reduction in Numeric Rating Scale (NRS) pain scores with movement at 24 hours postoperatively. This will be a prospective, randomized, double-blind, parallel-group, single-center study involving patients scheduled for primary unilateral TKA. Participants will be randomly assigned to one of two groups. All patients, clinicians (anesthesiologists and surgeon), and outcome assessors will be blinded to the group allocation using a double-dummy technique.

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; Randomized Controlled Trial; 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 48 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 (n=50)

ACTIVE COMPARATOR

Procedure: FTB; Procedure: IPACK block; Procedure: Sham Intervention 1 (Surgeon); Drug: Bupivacaine %0.25 (isobaric); Drug: Normal Saline (0.9% NaCl)

FTB + PAI Group (n=50)

EXPERIMENTAL

Procedure: FTB; Procedure: Sham Intervention 2 (Anesthesiologist); Procedure: PAI (Surgeon); Drug: Bupivacaine %0.25 (isobaric); Drug: Bupivacaine + Adrenaline + Methylprednisolone + Cefazoline; Drug: Normal Saline (0.9% NaCl)

Interventions

FTB PROCEDURE

All patients will receive an ultrasound-guided Femoral Triangle Block (FTB) with 20 mL of 0.25% Bupivacaine, supplemented by an Anterior Femoral Cutaneous Nerve block with 5 mL of the same solution.

FTB + PAI Group (n=50); FTB + iPACK Group (n=50)

Sham Intervention 1 (Surgeon) PROCEDURE

Patients will receive a sham Periarticular Infiltration (PAI) with an equivalent volume of normal saline intraoperatively.

FTB + iPACK Group (n=50)

PAI (Surgeon) PROCEDURE

The surgeon intraoperatively administers the standardized PAI cocktail (total volume approx. 50 mL): 24 mL 0.5% Bupivacaine, 0.3 mL Adrenaline (1:1000), 40 mg Methylprednisolone, 1 gr Cefazoline, and 22 mL 0.9% Sodium Chloride. The surgeon will administer the infiltration into the medial, lateral, and posterior quadrants of the knee capsule, specifically sparing the anterior quadrant.

FTB + PAI Group (n=50)

Bupivacaine %0.25 (isobaric) DRUG

Used for FTB and iPACK blocks.

FTB + PAI Group (n=50); FTB + iPACK Group (n=50)

Bupivacaine + Adrenaline + Methylprednisolone + Cefazoline DRUG

Used for PAI

FTB + PAI Group (n=50)

Normal Saline (0.9% NaCl) DRUG

Used for sham/placebo infiltration or block.

FTB + PAI Group (n=50); FTB + iPACK Group (n=50)

IPACK block PROCEDURE

Patients will receive an ultrasound-guided real iPACK block with 20 mL of 0.25% Bupivacaine

FTB + iPACK Group (n=50)

Sham Intervention 2 (Anesthesiologist) PROCEDURE

Patients will receive a sham iPACK block with an equivalent volume of normal saline preoperatively.

FTB + PAI Group (n=50)

Eligibility Criteria

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

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

MeSH Terms

Conditions

Pain, Postoperative; Osteoarthritis; Agnosia

Interventions

Surgeons; Anesthesiologists; Bupivacaine; Epinephrine; Methylprednisolone; Cefazolin; Saline Solution

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

Intervention Hierarchy (Ancestors)

Physicians; Health Personnel; Health Care Facilities Workforce and Services; Anesthetists; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cephalosporins; beta-Lactams; Lactams; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

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: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

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

Record last verified: 2025-12

Data Sharing

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