iPACK Block for Total Knee Arthroplasty

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Knee Osteoarthritis, Knee Pain Chronic, Knee Disease

Intervention / Treatment
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* Drug: Ropivacaine 0.5% Injectable Solution 20mL
* Drug: 0,9% normal saline 20mL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients > 18 years old undergoing unilateral total knee arthroplasty Exclusion Criteria: refusal to participate < 18 yo Chronic opioid use localized infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, triple-blind, placebo-controlled
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: preop iPACK block<br>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<br>* Ultrasound-guided iPACK block with 20mL of 0,5% ropivacaine<br>* Other names: Ropimol;|
| Experimental: preop placebo block<br>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<br>* Ultrasound-guided placebo block with 20mL of 0,9% normal saline<br>* Other names: placebo;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iPACK block, regional anesthesia, multimodal analgesia, total knee arthroplasty