Clinical trial NCT06087562: iPACK Block for Total Knee Arthroplasty
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Knee Osteoarthritis
Knee Pain Chronic
Knee Disease
Keywords: iPACK block
regional anesthesia
multimodal analgesia
total knee arthroplasty
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, triple-blind, placebo-controlled
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Numerical Rating Scale [Range from 0:no pain to 10:the worst pain]
timeFrame: within 24 hours postoperatively
measure: Numerical Rating Scale [Range from 0:no pain to 10:the worst pain]
timeFrame: 1 st postoperative day
measure: Numerical Rating Scale [Range from 0:no pain to 10:the worst pain]
timeFrame: 2nd postoperative day
measure: Numerical Rating Scale [Range from 0:no pain to 10:the worst pain]
timeFrame: 5 th postoperative day
measure: Opioid consumption 24 hours postoperatively
timeFrame: 24 hours postoperatively
measure: Opioid consumption 48 hours postoperatively
timeFrame: 24-48 hours postoperatively
measure: Opioid consumption 72 hours postoperatively
timeFrame: 48-72 hours postoperatively
measure: Opioid consumption >72 hours postoperatively
timeFrame: 72-96 hours postoperatively
measure: Time to first opioid administration
timeFrame: 0-12 hours postoperatively
Secondary outcomes:
measure: Rehabilitation process Verticalization by the balcony
timeFrame: 1st postoperative day
measure: Rehabilitation process Verticalization by the balcony
timeFrame: 2nd postoperative day
measure: Rehabilitation process Verticalization by the balcony
timeFrame: 5th postoperative day
measure: Rehabilitation process Verticalization with help
timeFrame: 1st postoperative day
measure: Rehabilitation process Verticalization with help
timeFrame: 2nd postoperative day
measure: Rehabilitation process Verticalization with help 5th day
timeFrame: 5th postoperative day
measure: Rehabilitation process Verticalization - impossible 1st day
timeFrame: 1st postoperative day
measure: Rehabilitation process Verticalization - impossible 2nd day
timeFrame: 2nd postoperative day
measure: Rehabilitation process Verticalization - impossible 5th day
timeFrame: 5th postoperative day
measure: Rehabilitation process Walking distance- unlimited with crutches 1st day
timeFrame: 1st postoperative day
measure: Rehabilitation process Walking distance- unlimited with crutches 2nd day
timeFrame: 2nd postoperative day
measure: Rehabilitation process Walking distance- unlimited with crutches 5th day
timeFrame: 5th postoperative day
measure: Rehabilitation process Walking distance- by the balcony 1st day
timeFrame: 1st postoperative day
measure: Rehabilitation process Walking distance- by the balcony 2nd day
timeFrame: 2nd postoperative day
measure: Rehabilitation process Walking distance- by the balcony 5th day
timeFrame: 5th postoperative day
measure: Rehabilitation process Walking distance- impossible- bed bound 1st day
timeFrame: 1st postoperative day
measure: Rehabilitation process Walking distance- impossible- bed bound 2nd day
timeFrame: 2nd postoperative day
measure: Rehabilitation process - getting out of bed- no problems 1st day
timeFrame: 1st postoperative day
measure: Rehabilitation process - getting out of bed- no problems 2nd day
timeFrame: 2nd postoperative day
measure: Rehabilitation process - getting out of bed- no problems 5th day
timeFrame: 5th postoperative day
measure: Rehabilitation process - getting out of bed- with help 1st day
timeFrame: 1st postoperative day
measure: Rehabilitation process - getting out of bed- with help 2nd day
timeFrame: 2nd postoperative day
measure: Rehabilitation process - getting out of bed- with help 5th day
timeFrame: 5th postoperative day
measure: Rehabilitation process - getting out of bed- with assistance 1st day
timeFrame: 1st postoperative day
measure: Rehabilitation process - getting out of bed- with assistance 2nd day
timeFrame: 2nd postoperative day
measure: Rehabilitation process - getting out of bed- with assistance 5th day
timeFrame: 5th postoperative day
measure: Rehabilitation process - RANGE OF MOTION - CONTRACTURE IN THE KNEE JOINT - full extension- 1st day
timeFrame: 1st day postoperative day
measure: Rehabilitation process - RANGE OF MOTION - CONTRACTURE IN THE KNEE JOINT - full extension- 2nd day
timeFrame: 2nd day postoperative day
measure: Rehabilitation process - RANGE OF MOTION - CONTRACTURE IN THE KNEE JOINT - full extension- 5th day
timeFrame: 5th day postoperative day
measure: Rehabilitation process - RANGE OF MOTION - flexion contracture IN THE KNEE JOINT - full extension- 1st day
timeFrame: 1st day postoperative day
measure: Rehabilitation process - RANGE OF MOTION - flexion contracture IN THE KNEE JOINT - full extension- 2nd day
timeFrame: 2nd day postoperative day
measure: Rehabilitation process - RANGE OF MOTION - flexion contracture IN THE KNEE JOINT - full extension- 5th day
timeFrame: 5th day postoperative day
measure: Rehabilitation process - bending range of motion- passive movement to 45 degrees- no pain- 1st day
timeFrame: 1st day postoperative day
measure: Rehabilitation process - bending range of motion- passive movement to 45 degrees- with pain- 1st day
timeFrame: 1st day postoperative day
measure: Rehabilitation process - bending range of motion- passive movement to 45 degrees- no pain- 2nd day
timeFrame: 2nd day postoperative day
measure: Rehabilitation process - bending range of motion- passive movement to 45 degrees- with pain- 2nd day
timeFrame: 2nd day postoperative day
measure: Rehabilitation process - bending range of motion- passive movement to 45 degrees- no pain- 5th day
timeFrame: 5th day postoperative day
measure: Rehabilitation process - bending range of motion- passive movement to 45 degrees- with pain- 5th day
timeFrame: 5th day postoperative day
measure: Rehabilitation process - bending range of motion- active movement to 90 degrees- no pain- 5th day
timeFrame: 1st day postoperative day
measure: Rehabilitation process - bending range of motion- active movement to 90 degrees- no pain- 2nd day
timeFrame: 2nd day postoperative day
measure: Rehabilitation process - bending range of motion- active movement to 90 degrees- no pain- 1st day
timeFrame: 1st day postoperative day
measure: Rehabilitation process - bending range of motion- active movement to 90 degrees- with pain- 1st day
timeFrame: 1st day postoperative day
measure: Rehabilitation process - bending range of motion- active movement to 90 degrees- with pain- 2nd day
timeFrame: 2nd day postoperative day
measure: Rehabilitation process - bending range of motion- active movement to 90 degrees- with pain- 5th day
timeFrame: 5th day postoperative day
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Poznan University of Medical Sciences
state: Wielkopolska
Study officials:
affiliation: Department of Palliative Medicine, University of Medical Sciences, Poznań, Poland
name: Małgorzata Domagalska, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Emergency Medicine
name: Zbigniew Żaba, PhD
role: STUDY_CHAIR
References: