iPACK Block vs. Periarticular Infiltration for TKA Pain Control

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

Interventions

PROCEDURE

FTB

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.

PROCEDURE

IPACK block

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

PROCEDURE

Sham Intervention 1 (Surgeon)

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

PROCEDURE

Sham Intervention 2 (Anesthesiologist)

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

PROCEDURE

PAI (Surgeon)

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.

DRUG

Bupivacaine %0.25 (isobaric)

Used for FTB and iPACK blocks.

DRUG

Bupivacaine + Adrenaline + Methylprednisolone + Cefazoline

Used for PAI

DRUG

Normal Saline (0.9% NaCl)

Used for sham/placebo infiltration or block.

Sponsors & Collaborators

• Turgutlu State Hospital

  lead OTHER

Principal Investigators

• Aslan · Turgutlu State Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-01

Primary Completion

2026-06-01

Completion

2026-08-01