iPACK Block for Total Knee Arthroplasty

Poznan University of Medical Sciences (PUMS)

Status and phase: Active, not recruiting; Phase 4

Conditions: Knee Pain Chronic; Knee Disease; Knee Osteoarthritis

Treatments: Drug: 0,9% normal saline 20mL; Drug: Ropivacaine 0.5% Injectable Solution 20mL

Study type: Interventional

Funder types: Other

Identifiers

NCT06087562

495/20

Details and patient eligibility

About

This randomized, double-blinded, placebo-controlled trial seeks to evaluate the efficacy of the rehabilitation process of the Interspace between the Popliteal Artery and Capsule of the Posterior Knee (iPACK) block in total knee arthroplasty.

Full description

The Interspace between the Popliteal Artery and Capsule of the Posterior Knee (iPACK) block, has been recently described and shows promise in providing analgesia to the knee joint. The effect of this block on postoperative rehabilitation is uncertain. This study aims to compare a preoperative iPACK block to a placebo block prior to total knee arthroplasty under spinal anesthesia. The primary outcome measure is verticalization, walking distance, ability to go out of bed, active lifting of the limb, range of motion in the hip joint, bending range of motion, and abduction range of motion. The secondary measure is postoperative pain assessment during rehabilitation.

Enrollment: 350 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients > 18 years old undergoing unilateral total knee arthroplasty

Exclusion criteria

• refusal to participate
• < 18 yo
• Chronic opioid use
• localized infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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350 participants in 2 patient groups

preop iPACK block

Experimental group

Description:

Patients will receive a preoperative ultrasound-guided Interspace between the Popliteal Artery and Capsule of the Posterior Knee (iPACK) block with 20 mL 0.5% ropivacaine. Using appropriate sterile precautions, and procedural sedation with up to 2 mg IV midazolam, an ultrasound (Mindray TE9) equipped with either a linear 15-6 megahertz (MHz), or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the distal femoral shaft and popliteal artery. After spinal anesthesia, a 22g 80 mm echogenic block needle (Stimuplex Ultra 360) is advanced lateral to medial, in-plane, from the anteromedial aspect of the knee, toward the space between the popliteal artery and femur. 20 mL 0.5% ropivacaine is injected into the space between the popliteal artery and femur. The needle is withdrawn, and the needle entry site is wiped clean.

Treatment:

Drug: Ropivacaine 0.5% Injectable Solution 20mL

preop placebo block

Experimental group

Description:

Patients will receive a preoperative ultrasound-guided Interspace between the Popliteal Artery and Capsule of the Posterior Knee (iPACK) block with 20 mL 0.5% ropivacaine. Using appropriate sterile precautions, and procedural sedation with up to 2 mg IV midazolam, an ultrasound (Mindray TE9) equipped with either a linear 15-6 megahertz (MHz), or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the distal femoral shaft and popliteal artery. After spinal anesthesia, a 22g 80 mm echogenic block needle (Stimuplex Ultra 360) is advanced lateral to medial, in-plane, from the anteromedial aspect of the knee, toward the space between the popliteal artery and femur. 20 mL 0.9% normal saline is injected into the space between the popliteal artery and femur. The needle is withdrawn, and the needle entry site is wiped clean.

Treatment:

Drug: 0,9% normal saline 20mL