Knee Disease, Knee Osteoarthritis, Knee Pain Chronic
Conditions
Keywords
iPACK block, regional anesthesia, multimodal analgesia, total knee arthroplasty
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.
Interventions
DRUGRopivacaine 0.5% Injectable Solution 20mL
Ultrasound-guided iPACK block with 20mL of 0,5% ropivacaine
DRUG0,9% normal saline 20mL
Ultrasound-guided placebo block with 20mL of 0,9% normal saline
Sponsors
Poznan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Subjects will be randomized to one of two groups with a computer-generated arm assignment. The sealed envelopes will be opened immediately before the nerve block. One group will receive an iPACK block, and the other will receive a placebo block. The provider performing the league will not be blinded. However, all other care team members, the patient, and the investigator collecting data will be blinded to randomization.
Intervention model description
Randomized, triple-blind, placebo-controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients \> 18 years old undergoing unilateral total knee arthroplasty
Exclusion criteria
* refusal to participate * \< 18 yo * Chronic opioid use * localized infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale [Range from 0:no pain to 10:the worst pain] | within 24 hours postoperatively | Numerical Rating Scale \[Range from 0:no pain to 10:the worst pain\] |
| Opioid consumption 24 hours postoperatively | 24 hours postoperatively | intravenous morphine equivalents (mg) |
| Opioid consumption 48 hours postoperatively | 24-48 hours postoperatively | intravenous morphine equivalents (mg) |
| Opioid consumption 72 hours postoperatively | 48-72 hours postoperatively | intravenous morphine equivalents (mg) |
| Opioid consumption >72 hours postoperatively | 72-96 hours postoperatively | intravenous morphine equivalents (mg) |
| Time to first opioid administration | 0-12 hours postoperatively | hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rehabilitation process Verticalization - impossible 5th day | 5th postoperative day | Verticalization- impossible (yes/no) |
| Rehabilitation process Walking distance- unlimited with crutches 1st day | 1st postoperative day | Walking distance- unlimited with crutches (yes/no) |
| Rehabilitation process Walking distance- unlimited with crutches 2nd day | 2nd postoperative day | Walking distance- unlimited with crutches (yes/no) |
| Rehabilitation process Walking distance- unlimited with crutches 5th day | 5th postoperative day | Walking distance- unlimited with crutches (yes/no) |
| Rehabilitation process Walking distance- by the balcony 1st day | 1st postoperative day | Walking distance- by the balcony (yes/no) |
| Rehabilitation process Walking distance- by the balcony 2nd day | 2nd postoperative day | Walking distance- by the balcony (yes/no) |
| Rehabilitation process Walking distance- by the balcony 5th day | 5th postoperative day | Walking distance- by the balcony (yes/no) |
| Rehabilitation process Walking distance- impossible- bed bound 2nd day | 2nd postoperative day | Walking distance- impossible- bed bound (yes/no) |
| Rehabilitation process - getting out of bed- no problems 1st day | 1st postoperative day | getting out of bed with no problems (yes/no) |
| Rehabilitation process - getting out of bed- no problems 2nd day | 2nd postoperative day | getting out of bed with no problems (yes/no) |
| Rehabilitation process - getting out of bed- no problems 5th day | 5th postoperative day | getting out of bed with no problems (yes/no) |
| Rehabilitation process - getting out of bed- with help 1st day | 1st postoperative day | getting out of bed with help (yes/no) |
| Rehabilitation process - getting out of bed- with help 2nd day | 2nd postoperative day | getting out of bed with help (yes/no) |
| Rehabilitation process - getting out of bed- with help 5th day | 5th postoperative day | getting out of bed with help (yes/no) |
| Rehabilitation process - getting out of bed- with assistance 1st day | 1st postoperative day | getting out of bed with assistance (yes/no) |
| Rehabilitation process - getting out of bed- with assistance 2nd day | 2nd postoperative day | getting out of bed with assistance (yes/no) |
| Rehabilitation process - getting out of bed- with assistance 5th day | 5th postoperative day | getting out of bed with assistance (yes/no) |
| Rehabilitation process - RANGE OF MOTION - CONTRACTURE IN THE KNEE JOINT - full extension- 1st day | 1st day postoperative day | CONTRACTURE IN THE KNEE JOINT - full extension (yes/no) |
| Rehabilitation process - RANGE OF MOTION - CONTRACTURE IN THE KNEE JOINT - full extension- 2nd day | 2nd day postoperative day | CONTRACTURE IN THE KNEE JOINT - full extension (yes/no) |
| Rehabilitation process - RANGE OF MOTION - CONTRACTURE IN THE KNEE JOINT - full extension- 5th day | 5th day postoperative day | CONTRACTURE IN THE KNEE JOINT - full extension (yes/no) |
| Rehabilitation process - RANGE OF MOTION - flexion contracture IN THE KNEE JOINT - full extension- 1st day | 1st day postoperative day | flexion contracture IN THE KNEE JOINT (yes/no) |
| Rehabilitation process - RANGE OF MOTION - flexion contracture IN THE KNEE JOINT - full extension- 2nd day | 2nd day postoperative day | flexion contracture IN THE KNEE JOINT (yes/no) |
| Rehabilitation process Verticalization by the balcony | 1st postoperative day | Verticalization by the balcony (binary outcome yes or no) |
| Rehabilitation process - bending range of motion- passive movement to 45 degrees- no pain- 1st day | 1st day postoperative day | bending range of motion- passive movement to 45 degrees with no pain- (yes/no) |
| Rehabilitation process - bending range of motion- passive movement to 45 degrees- with pain- 1st day | 1st day postoperative day | bending range of motion- passive movement to 45 degrees with pain- (yes/no) |
| Rehabilitation process - bending range of motion- passive movement to 45 degrees- no pain- 2nd day | 2nd day postoperative day | bending range of motion- passive movement to 45 degrees with no pain- (yes/no) |
| Rehabilitation process - bending range of motion- passive movement to 45 degrees- with pain- 2nd day | 2nd day postoperative day | bending range of motion- passive movement to 45 degrees with pain- (yes/no) |
| Rehabilitation process - bending range of motion- passive movement to 45 degrees- no pain- 5th day | 5th day postoperative day | bending range of motion- passive movement to 45 degrees with no pain- (yes/no) |
| Rehabilitation process - bending range of motion- passive movement to 45 degrees- with pain- 5th day | 5th day postoperative day | bending range of motion- passive movement to 45 degrees with pain- (yes/no) |
| Rehabilitation process - bending range of motion- active movement to 90 degrees- no pain- 5th day | 1st day postoperative day | bending range of motion- active movement to 90 degrees with no pain- (yes/no) |
| Rehabilitation process - bending range of motion- active movement to 90 degrees- no pain- 2nd day | 2nd day postoperative day | bending range of motion- active movement to 90 degrees with no pain- (yes/no) |
| Rehabilitation process - bending range of motion- active movement to 90 degrees- no pain- 1st day | 1st day postoperative day | bending range of motion- active movement to 90 degrees with no pain- (yes/no) |
| Rehabilitation process - bending range of motion- active movement to 90 degrees- with pain- 1st day | 1st day postoperative day | bending range of motion- active movement to 90 degrees with pain- (yes/no) |
| Rehabilitation process - bending range of motion- active movement to 90 degrees- with pain- 2nd day | 2nd day postoperative day | bending range of motion- active movement to 90 degrees with pain- (yes/no) |
| Rehabilitation process - bending range of motion- active movement to 90 degrees- with pain- 5th day | 5th day postoperative day | bending range of motion- active movement to 90 degrees with pain- (yes/no) |
| Rehabilitation process - RANGE OF MOTION - flexion contracture IN THE KNEE JOINT - full extension- 5th day | 5th day postoperative day | flexion contracture IN THE KNEE JOINT (yes/no) |
| Rehabilitation process Verticalization with help | 1st postoperative day | Verticalization- with help (yes/no) |
| Rehabilitation process Walking distance- impossible- bed bound 1st day | 1st postoperative day | Walking distance- impossible- bed bound (yes/no) |
| Rehabilitation process Verticalization with help 5th day | 5th postoperative day | Verticalization- with help (yes/no) |
| Rehabilitation process Verticalization - impossible 1st day | 1st postoperative day | Verticalization- impossible (yes/no) |
| Rehabilitation process Verticalization - impossible 2nd day | 2nd postoperative day | Verticalization- impossible (yes/no) |
Countries
Poland
Outcome results
None listed