iPACK Block for Total Knee Arthroplasty

Interspace Between the Popliteal Artery and Capsule of the Posterior Knee (iPACK) Block for Postoperative Rehabilitation in Total Knee Arthroplasty: a Randomized Control Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Knee Osteoarthritis; Knee Pain Chronic; Knee Disease
• Intervention / Treatment: Drug: Ropivacaine 0.5% Injectable Solution 20mL; Drug: 0,9% normal saline 20mL

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.

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Wielkopolska
    • Poznan, Wielkopolska, Poland, 61-701
      • Poznan University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients > 18 years old undergoing unilateral total knee arthroplasty

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Ropivacaine 0.5% Injectable Solution 20mL; Ultrasound-guided iPACK block with 20mL of 0,5% ropivacaine; Other Names: Ropimol
Experimental: 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.	Drug: 0,9% normal saline 20mL; Ultrasound-guided placebo block with 20mL of 0,9% normal saline; Other Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale [Range from 0:no pain to 10:the worst pain]	Numerical Rating Scale [Range from 0:no pain to 10:the worst pain]	within 24 hours postoperatively
Numerical Rating Scale [Range from 0:no pain to 10:the worst pain]	NRS (numerical rating scale from 0- no pain to 10- the worst pain)	1 st postoperative day
Numerical Rating Scale [Range from 0:no pain to 10:the worst pain]	NRS (numerical rating scale from 0- no pain to 10- the worst pain)	2nd postoperative day
Numerical Rating Scale [Range from 0:no pain to 10:the worst pain]	NRS (numerical rating scale from 0- no pain to 10- the worst pain)	5 th postoperative day
Opioid consumption 24 hours postoperatively	intravenous morphine equivalents (mg)	24 hours postoperatively
Opioid consumption 48 hours postoperatively	intravenous morphine equivalents (mg)	24-48 hours postoperatively
Opioid consumption 72 hours postoperatively	intravenous morphine equivalents (mg)	48-72 hours postoperatively
Opioid consumption >72 hours postoperatively	intravenous morphine equivalents (mg)	72-96 hours postoperatively
Time to first opioid administration	hours	0-12 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rehabilitation process Verticalization by the balcony	Verticalization by the balcony (binary outcome yes or no)	1st postoperative day
Rehabilitation process Verticalization by the balcony	Verticalization by the balcony (binary outcome yes or no)	2nd postoperative day
Rehabilitation process Verticalization by the balcony	Verticalization by the balcony (binary outcome yes or no)	5th postoperative day
Rehabilitation process Verticalization with help	Verticalization- with help (yes/no)	1st postoperative day
Rehabilitation process Verticalization with help	Verticalization- with help (yes/no)	2nd postoperative day
Rehabilitation process Verticalization with help 5th day	Verticalization- with help (yes/no)	5th postoperative day
Rehabilitation process Verticalization - impossible 1st day	Verticalization- impossible (yes/no)	1st postoperative day
Rehabilitation process Verticalization - impossible 2nd day	Verticalization- impossible (yes/no)	2nd postoperative day
Rehabilitation process Verticalization - impossible 5th day	Verticalization- impossible (yes/no)	5th postoperative day
Rehabilitation process Walking distance- unlimited with crutches 1st day	Walking distance- unlimited with crutches (yes/no)	1st postoperative day
Rehabilitation process Walking distance- unlimited with crutches 2nd day	Walking distance- unlimited with crutches (yes/no)	2nd postoperative day
Rehabilitation process Walking distance- unlimited with crutches 5th day	Walking distance- unlimited with crutches (yes/no)	5th postoperative day
Rehabilitation process Walking distance- by the balcony 1st day	Walking distance- by the balcony (yes/no)	1st postoperative day
Rehabilitation process Walking distance- by the balcony 2nd day	Walking distance- by the balcony (yes/no)	2nd postoperative day
Rehabilitation process Walking distance- by the balcony 5th day	Walking distance- by the balcony (yes/no)	5th postoperative day
Rehabilitation process Walking distance- impossible- bed bound 1st day	Walking distance- impossible- bed bound (yes/no)	1st postoperative day
Rehabilitation process Walking distance- impossible- bed bound 2nd day	Walking distance- impossible- bed bound (yes/no)	2nd postoperative day
Rehabilitation process - getting out of bed- no problems 1st day	getting out of bed with no problems (yes/no)	1st postoperative day
Rehabilitation process - getting out of bed- no problems 2nd day	getting out of bed with no problems (yes/no)	2nd postoperative day
Rehabilitation process - getting out of bed- no problems 5th day	getting out of bed with no problems (yes/no)	5th postoperative day
Rehabilitation process - getting out of bed- with help 1st day	getting out of bed with help (yes/no)	1st postoperative day
Rehabilitation process - getting out of bed- with help 2nd day	getting out of bed with help (yes/no)	2nd postoperative day
Rehabilitation process - getting out of bed- with help 5th day	getting out of bed with help (yes/no)	5th postoperative day
Rehabilitation process - getting out of bed- with assistance 1st day	getting out of bed with assistance (yes/no)	1st postoperative day
Rehabilitation process - getting out of bed- with assistance 2nd day	getting out of bed with assistance (yes/no)	2nd postoperative day
Rehabilitation process - getting out of bed- with assistance 5th day	getting out of bed with assistance (yes/no)	5th postoperative day
Rehabilitation process - RANGE OF MOTION - CONTRACTURE IN THE KNEE JOINT - full extension- 1st day	CONTRACTURE IN THE KNEE JOINT - full extension (yes/no)	1st day postoperative day
Rehabilitation process - RANGE OF MOTION - CONTRACTURE IN THE KNEE JOINT - full extension- 2nd day	CONTRACTURE IN THE KNEE JOINT - full extension (yes/no)	2nd day postoperative day
Rehabilitation process - RANGE OF MOTION - CONTRACTURE IN THE KNEE JOINT - full extension- 5th day	CONTRACTURE IN THE KNEE JOINT - full extension (yes/no)	5th day postoperative day
Rehabilitation process - RANGE OF MOTION - flexion contracture IN THE KNEE JOINT - full extension- 1st day	flexion contracture IN THE KNEE JOINT (yes/no)	1st day postoperative day
Rehabilitation process - RANGE OF MOTION - flexion contracture IN THE KNEE JOINT - full extension- 2nd day	flexion contracture IN THE KNEE JOINT (yes/no)	2nd day postoperative day
Rehabilitation process - RANGE OF MOTION - flexion contracture IN THE KNEE JOINT - full extension- 5th day	flexion contracture IN THE KNEE JOINT (yes/no)	5th day postoperative day
Rehabilitation process - bending range of motion- passive movement to 45 degrees- no pain- 1st day	bending range of motion- passive movement to 45 degrees with no pain- (yes/no)	1st day postoperative day
Rehabilitation process - bending range of motion- passive movement to 45 degrees- with pain- 1st day	bending range of motion- passive movement to 45 degrees with pain- (yes/no)	1st day postoperative day
Rehabilitation process - bending range of motion- passive movement to 45 degrees- no pain- 2nd day	bending range of motion- passive movement to 45 degrees with no pain- (yes/no)	2nd day postoperative day
Rehabilitation process - bending range of motion- passive movement to 45 degrees- with pain- 2nd day	bending range of motion- passive movement to 45 degrees with pain- (yes/no)	2nd day postoperative day
Rehabilitation process - bending range of motion- passive movement to 45 degrees- no pain- 5th day	bending range of motion- passive movement to 45 degrees with no pain- (yes/no)	5th day postoperative day
Rehabilitation process - bending range of motion- passive movement to 45 degrees- with pain- 5th day	bending range of motion- passive movement to 45 degrees with pain- (yes/no)	5th day postoperative day
Rehabilitation process - bending range of motion- active movement to 90 degrees- no pain- 5th day	bending range of motion- active movement to 90 degrees with no pain- (yes/no)	1st day postoperative day
Rehabilitation process - bending range of motion- active movement to 90 degrees- no pain- 2nd day	bending range of motion- active movement to 90 degrees with no pain- (yes/no)	2nd day postoperative day
Rehabilitation process - bending range of motion- active movement to 90 degrees- no pain- 1st day	bending range of motion- active movement to 90 degrees with no pain- (yes/no)	1st day postoperative day
Rehabilitation process - bending range of motion- active movement to 90 degrees- with pain- 1st day	bending range of motion- active movement to 90 degrees with pain- (yes/no)	1st day postoperative day
Rehabilitation process - bending range of motion- active movement to 90 degrees- with pain- 2nd day	bending range of motion- active movement to 90 degrees with pain- (yes/no)	2nd day postoperative day
Rehabilitation process - bending range of motion- active movement to 90 degrees- with pain- 5th day	bending range of motion- active movement to 90 degrees with pain- (yes/no)	5th day postoperative day

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Principal Investigator: Małgorzata Domagalska, PhD, Department of Palliative Medicine, University of Medical Sciences, Poznań, Poland; Study Chair: Zbigniew Żaba, PhD, Department of Emergency Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2020
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: February 19, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: total knee arthroplasty; regional anesthesia; multimodal analgesia; iPACK block
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 495/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data presented in this study are available on request from the corresponding author.
• IPD Sharing Time Frame: December 2024
• IPD Sharing Access Criteria: The data presented in this study are available on request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No