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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
350
Ultrasound-guided iPACK block with 20mL of 0,5% ropivacaine
Ultrasound-guided placebo block with 20mL of 0,9% normal saline
Poznan University of Medical Sciences
Poznan, Wielkopolska, Poland
Numerical Rating Scale [Range from 0:no pain to 10:the worst pain]
Numerical Rating Scale \[Range from 0:no pain to 10:the worst pain\]
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 5 th postoperative day
Opioid consumption 24 hours postoperatively
intravenous morphine equivalents (mg)
Time frame: 24 hours postoperatively
Opioid consumption 48 hours postoperatively
intravenous morphine equivalents (mg)
Time frame: 24-48 hours postoperatively
Opioid consumption 72 hours postoperatively
intravenous morphine equivalents (mg)
Time frame: 48-72 hours postoperatively
Opioid consumption >72 hours postoperatively
intravenous morphine equivalents (mg)
Time frame: 72-96 hours postoperatively
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Time to first opioid administration
hours
Time frame: 0-12 hours postoperatively
Rehabilitation process Verticalization by the balcony
Verticalization by the balcony (binary outcome yes or no)
Time frame: 1st postoperative day
Rehabilitation process Verticalization by the balcony
Verticalization by the balcony (binary outcome yes or no)
Time frame: 2nd postoperative day
Rehabilitation process Verticalization by the balcony
Verticalization by the balcony (binary outcome yes or no)
Time frame: 5th postoperative day
Rehabilitation process Verticalization with help
Verticalization- with help (yes/no)
Time frame: 1st postoperative day
Rehabilitation process Verticalization with help
Verticalization- with help (yes/no)
Time frame: 2nd postoperative day
Rehabilitation process Verticalization with help 5th day
Verticalization- with help (yes/no)
Time frame: 5th postoperative day
Rehabilitation process Verticalization - impossible 1st day
Verticalization- impossible (yes/no)
Time frame: 1st postoperative day
Rehabilitation process Verticalization - impossible 2nd day
Verticalization- impossible (yes/no)
Time frame: 2nd postoperative day
Rehabilitation process Verticalization - impossible 5th day
Verticalization- impossible (yes/no)
Time frame: 5th postoperative day
Rehabilitation process Walking distance- unlimited with crutches 1st day
Walking distance- unlimited with crutches (yes/no)
Time frame: 1st postoperative day
Rehabilitation process Walking distance- unlimited with crutches 2nd day
Walking distance- unlimited with crutches (yes/no)
Time frame: 2nd postoperative day
Rehabilitation process Walking distance- unlimited with crutches 5th day
Walking distance- unlimited with crutches (yes/no)
Time frame: 5th postoperative day
Rehabilitation process Walking distance- by the balcony 1st day
Walking distance- by the balcony (yes/no)
Time frame: 1st postoperative day
Rehabilitation process Walking distance- by the balcony 2nd day
Walking distance- by the balcony (yes/no)
Time frame: 2nd postoperative day
Rehabilitation process Walking distance- by the balcony 5th day
Walking distance- by the balcony (yes/no)
Time frame: 5th postoperative day
Rehabilitation process Walking distance- impossible- bed bound 1st day
Walking distance- impossible- bed bound (yes/no)
Time frame: 1st postoperative day
Rehabilitation process Walking distance- impossible- bed bound 2nd day
Walking distance- impossible- bed bound (yes/no)
Time frame: 2nd postoperative day
Rehabilitation process - getting out of bed- no problems 1st day
getting out of bed with no problems (yes/no)
Time frame: 1st postoperative day
Rehabilitation process - getting out of bed- no problems 2nd day
getting out of bed with no problems (yes/no)
Time frame: 2nd postoperative day
Rehabilitation process - getting out of bed- no problems 5th day
getting out of bed with no problems (yes/no)
Time frame: 5th postoperative day
Rehabilitation process - getting out of bed- with help 1st day
getting out of bed with help (yes/no)
Time frame: 1st postoperative day
Rehabilitation process - getting out of bed- with help 2nd day
getting out of bed with help (yes/no)
Time frame: 2nd postoperative day
Rehabilitation process - getting out of bed- with help 5th day
getting out of bed with help (yes/no)
Time frame: 5th postoperative day
Rehabilitation process - getting out of bed- with assistance 1st day
getting out of bed with assistance (yes/no)
Time frame: 1st postoperative day
Rehabilitation process - getting out of bed- with assistance 2nd day
getting out of bed with assistance (yes/no)
Time frame: 2nd postoperative day
Rehabilitation process - getting out of bed- with assistance 5th day
getting out of bed with assistance (yes/no)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 5th day postoperative day