iPACK Block for Total Knee Arthroplasty

NCT ID: NCT06087562

Last Updated: 2023-10-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-16
• Study Completion Date: 2024-12-30

Brief Summary

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.

Detailed 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.

Conditions

Knee Osteoarthritis; Knee Pain Chronic; Knee Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

preop iPACK block

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 The needle is withdrawn, and the needle entry site is wiped clean.

Group Type: EXPERIMENTAL

Ropivacaine 0.5% Injectable Solution 20mL

Intervention Type: DRUG

Ultrasound-guided iPACK block with 20mL of 0,5% ropivacaine

preop placebo block

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.

Group Type: EXPERIMENTAL

0,9% normal saline 20mL

Intervention Type: DRUG

Ultrasound-guided placebo block with 20mL of 0,9% normal saline

Interventions

Ropivacaine 0.5% Injectable Solution 20mL

Ultrasound-guided iPACK block with 20mL of 0,5% ropivacaine

Intervention Type: DRUG

0,9% normal saline 20mL

Ultrasound-guided placebo block with 20mL of 0,9% normal saline

Intervention Type: DRUG

Other Intervention Names

Ropimol; placebo

Eligibility Criteria

Inclusion Criteria

• Patients > 18 years old undergoing unilateral total knee arthroplasty

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Poznan University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Małgorzata Domagalska, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Palliative Medicine, University of Medical Sciences, Poznań, Poland

Zbigniew Żaba, PhD

Role: STUDY_CHAIR

Department of Emergency Medicine

Locations

Poznan University of Medical Sciences

Poznan, Wielkopolska, Poland

Countries

Poland

Other Identifiers

495/20

Identifier Type: -

Identifier Source: org_study_id