iPACK Block for Total Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06087562
• Other study ID #: 495/20
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: June 16, 2020
• Est. completion date: December 30, 2024

Study information

• Verified date: October 2023
• Source: Poznan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: December 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients > 18 years old undergoing unilateral total knee arthroplasty

Exclusion Criteria:

• refusal to participate

• < 18 yo

• Chronic opioid use

• localized infection

Related Conditions & MeSH terms

• Knee Disease
• Knee Osteoarthritis
• Knee Pain Chronic
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Ropivacaine 0.5% Injectable Solution 20mL
Ultrasound-guided iPACK block with 20mL of 0,5% ropivacaine
• 0,9% normal saline 20mL
Ultrasound-guided placebo block with 20mL of 0,9% normal saline

Locations

Country	Name	City	State
Poland	Poznan University of Medical Sciences	Poznan	Wielkopolska

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Opioid consumption 24 hours postoperatively	intravenous morphine equivalents (mg)	24 hours postoperatively
Primary	Opioid consumption 48 hours postoperatively	intravenous morphine equivalents (mg)	24-48 hours postoperatively
Primary	Opioid consumption 72 hours postoperatively	intravenous morphine equivalents (mg)	48-72 hours postoperatively
Primary	Opioid consumption >72 hours postoperatively	intravenous morphine equivalents (mg)	72-96 hours postoperatively
Primary	Time to first opioid administration	hours	0-12 hours postoperatively
Secondary	Rehabilitation process Verticalization by the balcony	Verticalization by the balcony (binary outcome yes or no)	1st postoperative day
Secondary	Rehabilitation process Verticalization by the balcony	Verticalization by the balcony (binary outcome yes or no)	2nd postoperative day
Secondary	Rehabilitation process Verticalization by the balcony	Verticalization by the balcony (binary outcome yes or no)	5th postoperative day
Secondary	Rehabilitation process Verticalization with help	Verticalization- with help (yes/no)	1st postoperative day
Secondary	Rehabilitation process Verticalization with help	Verticalization- with help (yes/no)	2nd postoperative day
Secondary	Rehabilitation process Verticalization with help 5th day	Verticalization- with help (yes/no)	5th postoperative day
Secondary	Rehabilitation process Verticalization - impossible 1st day	Verticalization- impossible (yes/no)	1st postoperative day
Secondary	Rehabilitation process Verticalization - impossible 2nd day	Verticalization- impossible (yes/no)	2nd postoperative day
Secondary	Rehabilitation process Verticalization - impossible 5th day	Verticalization- impossible (yes/no)	5th postoperative day
Secondary	Rehabilitation process Walking distance- unlimited with crutches 1st day	Walking distance- unlimited with crutches (yes/no)	1st postoperative day
Secondary	Rehabilitation process Walking distance- unlimited with crutches 2nd day	Walking distance- unlimited with crutches (yes/no)	2nd postoperative day
Secondary	Rehabilitation process Walking distance- unlimited with crutches 5th day	Walking distance- unlimited with crutches (yes/no)	5th postoperative day
Secondary	Rehabilitation process Walking distance- by the balcony 1st day	Walking distance- by the balcony (yes/no)	1st postoperative day
Secondary	Rehabilitation process Walking distance- by the balcony 2nd day	Walking distance- by the balcony (yes/no)	2nd postoperative day
Secondary	Rehabilitation process Walking distance- by the balcony 5th day	Walking distance- by the balcony (yes/no)	5th postoperative day
Secondary	Rehabilitation process Walking distance- impossible- bed bound 1st day	Walking distance- impossible- bed bound (yes/no)	1st postoperative day
Secondary	Rehabilitation process Walking distance- impossible- bed bound 2nd day	Walking distance- impossible- bed bound (yes/no)	2nd postoperative day
Secondary	Rehabilitation process - getting out of bed- no problems 1st day	getting out of bed with no problems (yes/no)	1st postoperative day
Secondary	Rehabilitation process - getting out of bed- no problems 2nd day	getting out of bed with no problems (yes/no)	2nd postoperative day
Secondary	Rehabilitation process - getting out of bed- no problems 5th day	getting out of bed with no problems (yes/no)	5th postoperative day
Secondary	Rehabilitation process - getting out of bed- with help 1st day	getting out of bed with help (yes/no)	1st postoperative day
Secondary	Rehabilitation process - getting out of bed- with help 2nd day	getting out of bed with help (yes/no)	2nd postoperative day
Secondary	Rehabilitation process - getting out of bed- with help 5th day	getting out of bed with help (yes/no)	5th postoperative day
Secondary	Rehabilitation process - getting out of bed- with assistance 1st day	getting out of bed with assistance (yes/no)	1st postoperative day
Secondary	Rehabilitation process - getting out of bed- with assistance 2nd day	getting out of bed with assistance (yes/no)	2nd postoperative day
Secondary	Rehabilitation process - getting out of bed- with assistance 5th day	getting out of bed with assistance (yes/no)	5th postoperative day
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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