Knee OsteoarthritisPhase 4NCT06087562
iPACK Block for Total Knee Arthroplasty
A Phase 4 study testing Ropivacaine 0.5% Injectable Solution 20mL and 0,9% normal saline 20mL in people with Knee Osteoarthritis and Knee Pain Chronic, run by Poznan University of Medical Sciences at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis, Knee Pain Chronic, Knee Disease
- What is being tested?
- Ropivacaine 0.5% Injectable Solution 20mL and 0,9% normal saline 20mL
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 sitePoland
- Study dates
- 16 Jun 2020to 30 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients > 18 years old undergoing unilateral total knee arthroplasty
Who cannot join
- refusal to participate
- < 18 yo
- Chronic opioid use
- localized infection
Trial locations and contacts
1 site in 1 country.
Poland1 site
Poznan University of Medical Sciences
Poznan, Wielkopolska, 61-701
About this study
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
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.
Read the 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.
- Conditions
- Knee Osteoarthritis, Knee Pain Chronic, Knee Disease
- Being tested
- Ropivacaine 0.5% Injectable Solution 20mL, 0,9% normal saline 20mL
- Keywords
- iPACK block, regional anesthesia, multimodal analgesia, total knee arthroplasty
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.5% Injectable Solution 20mLDrug
Also called Ropimol
Ultrasound-guided iPACK block with 20mL of 0,5% ropivacaine
0,9% normal saline 20mLDrug
Also called placebo
Ultrasound-guided placebo block with 20mL of 0,9% normal saline
| Study group | Role | What they receive |
|---|---|---|
| preop iPACK block | Experimental | 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. Receives: Drug: Ropivacaine 0.5% Injectable Solution 20mL |
| preop placebo block | Experimental | 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. Receives: Drug: 0,9% normal saline 20mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 5 th postoperative day
Opioid consumption 24 hours postoperatively
intravenous morphine equivalents (mg)
Measured: 24 hours postoperatively
Opioid consumption 48 hours postoperatively
intravenous morphine equivalents (mg)
Measured: 24-48 hours postoperatively
Opioid consumption 72 hours postoperatively
intravenous morphine equivalents (mg)
Measured: 48-72 hours postoperatively
Opioid consumption >72 hours postoperatively
intravenous morphine equivalents (mg)
Measured: 72-96 hours postoperatively
Time to first opioid administration
hours
Measured: 0-12 hours postoperatively
Secondary outcomes (44)
Rehabilitation process Verticalization by the balcony
Verticalization by the balcony (binary outcome yes or no)
Measured: 1st postoperative day
Rehabilitation process Verticalization by the balcony
Verticalization by the balcony (binary outcome yes or no)
Measured: 2nd postoperative day
Rehabilitation process Verticalization by the balcony
Verticalization by the balcony (binary outcome yes or no)
Measured: 5th postoperative day
Rehabilitation process Verticalization with help
Verticalization- with help (yes/no)
Measured: 1st postoperative day
Rehabilitation process Verticalization with help
Verticalization- with help (yes/no)
Measured: 2nd postoperative day
Rehabilitation process Verticalization with help 5th day
Verticalization- with help (yes/no)
Measured: 5th postoperative day
Rehabilitation process Verticalization - impossible 1st day
Verticalization- impossible (yes/no)
Measured: 1st postoperative day
Rehabilitation process Verticalization - impossible 2nd day
Verticalization- impossible (yes/no)
Measured: 2nd postoperative day
Rehabilitation process Verticalization - impossible 5th day
Verticalization- impossible (yes/no)
Measured: 5th postoperative day
Rehabilitation process Walking distance- unlimited with crutches 1st day
Walking distance- unlimited with crutches (yes/no)
Measured: 1st postoperative day
Rehabilitation process Walking distance- unlimited with crutches 2nd day
Walking distance- unlimited with crutches (yes/no)
Measured: 2nd postoperative day
Rehabilitation process Walking distance- unlimited with crutches 5th day
Walking distance- unlimited with crutches (yes/no)
Measured: 5th postoperative day
Rehabilitation process Walking distance- by the balcony 1st day
Walking distance- by the balcony (yes/no)
Measured: 1st postoperative day
Rehabilitation process Walking distance- by the balcony 2nd day
Walking distance- by the balcony (yes/no)
Measured: 2nd postoperative day
Rehabilitation process Walking distance- by the balcony 5th day
Walking distance- by the balcony (yes/no)
Measured: 5th postoperative day
Rehabilitation process Walking distance- impossible- bed bound 1st day
Walking distance- impossible- bed bound (yes/no)
Measured: 1st postoperative day
Rehabilitation process Walking distance- impossible- bed bound 2nd day
Walking distance- impossible- bed bound (yes/no)
Measured: 2nd postoperative day
Rehabilitation process - getting out of bed- no problems 1st day
getting out of bed with no problems (yes/no)
Measured: 1st postoperative day
Rehabilitation process - getting out of bed- no problems 2nd day
getting out of bed with no problems (yes/no)
Measured: 2nd postoperative day
Rehabilitation process - getting out of bed- no problems 5th day
getting out of bed with no problems (yes/no)
Measured: 5th postoperative day
Rehabilitation process - getting out of bed- with help 1st day
getting out of bed with help (yes/no)
Measured: 1st postoperative day
Rehabilitation process - getting out of bed- with help 2nd day
getting out of bed with help (yes/no)
Measured: 2nd postoperative day
Rehabilitation process - getting out of bed- with help 5th day
getting out of bed with help (yes/no)
Measured: 5th postoperative day
Rehabilitation process - getting out of bed- with assistance 1st day
getting out of bed with assistance (yes/no)
Measured: 1st postoperative day
Rehabilitation process - getting out of bed- with assistance 2nd day
getting out of bed with assistance (yes/no)
Measured: 2nd postoperative day
Rehabilitation process - getting out of bed- with assistance 5th day
getting out of bed with assistance (yes/no)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 5th day postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start16 Jun 2020
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, triple-blind, placebo-controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Małgorzata Domagalska, PhD, Principal investigator, Department of Palliative Medicine, University of Medical Sciences, Poznań, PolandZbigniew Żaba, PhD, Study chair, Department of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087562
- Sponsor's protocol ID
- 495/20
- Status last verified
- Oct 2023
- First submitted
- 19 Feb 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data presented in this study are available on request from the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06087562
- Acronym / sponsor ID
- 495/20
- Conditions
- Knee Osteoarthritis, Knee Pain Chronic, Knee Disease
- Keywords
- iPACK block, regional anesthesia, multimodal analgesia, total knee arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, triple-blind, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| preop iPACK block | Experimental | Drug: Ropivacaine 0.5% Injectable Solution 20mLPatients 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. |
| preop placebo block | Experimental | Drug: 0,9% normal saline 20mLPatients 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients > 18 years old undergoing unilateral total knee arthroplasty
Key exclusion criteria (4 listed)
- refusal to participate
- < 18 yo
- Chronic opioid use
- localized infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine 0.5% Injectable Solution 20mLAlso: RopimolUltrasound-guided iPACK block with 20mL of 0,5% ropivacaine | Drug | preop iPACK block |
| 0,9% normal saline 20mLAlso: placeboUltrasound-guided placebo block with 20mL of 0,9% normal saline | Drug | preop placebo block |
Primary outcome
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]
Numerical Rating Scale [Range from 0:no pain to 10:the worst pain]
Time frame: 1 st postoperative day
NRS (numerical rating scale from 0- no pain to 10- the worst pain)
Numerical Rating Scale [Range from 0:no pain to 10:the worst pain]
Time frame: 2nd postoperative day
NRS (numerical rating scale from 0- no pain to 10- the worst pain)
Numerical Rating Scale [Range from 0:no pain to 10:the worst pain]
Time frame: 5 th postoperative day
NRS (numerical rating scale from 0- no pain to 10- the worst pain)
Opioid consumption 24 hours postoperatively
Time frame: 24 hours postoperatively
intravenous morphine equivalents (mg)
Opioid consumption 48 hours postoperatively
Time frame: 24-48 hours postoperatively
intravenous morphine equivalents (mg)
Opioid consumption 72 hours postoperatively
Time frame: 48-72 hours postoperatively
intravenous morphine equivalents (mg)
Opioid consumption >72 hours postoperatively
Time frame: 72-96 hours postoperatively
intravenous morphine equivalents (mg)
Time to first opioid administration
Time frame: 0-12 hours postoperatively
hours
44 secondary outcomes
Rehabilitation process Verticalization by the balcony
Time frame: 1st postoperative day
Rehabilitation process Verticalization by the balcony
Time frame: 2nd postoperative day
Rehabilitation process Verticalization by the balcony
Time frame: 5th postoperative day
Rehabilitation process Verticalization with help
Time frame: 1st postoperative day
Rehabilitation process Verticalization with help
Time frame: 2nd postoperative day
Rehabilitation process Verticalization with help 5th day
Time frame: 5th postoperative day
Rehabilitation process Verticalization - impossible 1st day
Time frame: 1st postoperative day
Rehabilitation process Verticalization - impossible 2nd day
Time frame: 2nd postoperative day
Rehabilitation process Verticalization - impossible 5th day
Time frame: 5th postoperative day
Rehabilitation process Walking distance- unlimited with crutches 1st day
Time frame: 1st postoperative day
Rehabilitation process Walking distance- unlimited with crutches 2nd day
Time frame: 2nd postoperative day
Rehabilitation process Walking distance- unlimited with crutches 5th day
Time frame: 5th postoperative day
Rehabilitation process Walking distance- by the balcony 1st day
Time frame: 1st postoperative day
Rehabilitation process Walking distance- by the balcony 2nd day
Time frame: 2nd postoperative day
Rehabilitation process Walking distance- by the balcony 5th day
Time frame: 5th postoperative day
Rehabilitation process Walking distance- impossible- bed bound 1st day
Time frame: 1st postoperative day
Rehabilitation process Walking distance- impossible- bed bound 2nd day
Time frame: 2nd postoperative day
Rehabilitation process - getting out of bed- no problems 1st day
Time frame: 1st postoperative day
Rehabilitation process - getting out of bed- no problems 2nd day
Time frame: 2nd postoperative day
Rehabilitation process - getting out of bed- no problems 5th day
Time frame: 5th postoperative day
Rehabilitation process - getting out of bed- with help 1st day
Time frame: 1st postoperative day
Rehabilitation process - getting out of bed- with help 2nd day
Time frame: 2nd postoperative day
Rehabilitation process - getting out of bed- with help 5th day
Time frame: 5th postoperative day
Rehabilitation process - getting out of bed- with assistance 1st day
Time frame: 1st postoperative day
Rehabilitation process - getting out of bed- with assistance 2nd day
Time frame: 2nd postoperative day
Rehabilitation process - getting out of bed- with assistance 5th day
Time frame: 5th postoperative day
Rehabilitation process - RANGE OF MOTION - CONTRACTURE IN THE KNEE JOINT - full extension- 1st day
Time frame: 1st day postoperative day
Rehabilitation process - RANGE OF MOTION - CONTRACTURE IN THE KNEE JOINT - full extension- 2nd day
Time frame: 2nd day postoperative day
Rehabilitation process - RANGE OF MOTION - CONTRACTURE IN THE KNEE JOINT - full extension- 5th day
Time frame: 5th day postoperative day
Rehabilitation process - RANGE OF MOTION - flexion contracture IN THE KNEE JOINT - full extension- 1st day
Time frame: 1st day postoperative day
Rehabilitation process - RANGE OF MOTION - flexion contracture IN THE KNEE JOINT - full extension- 2nd day
Time frame: 2nd day postoperative day
Rehabilitation process - RANGE OF MOTION - flexion contracture IN THE KNEE JOINT - full extension- 5th day
Time frame: 5th day postoperative day
Rehabilitation process - bending range of motion- passive movement to 45 degrees- no pain- 1st day
Time frame: 1st day postoperative day
Rehabilitation process - bending range of motion- passive movement to 45 degrees- with pain- 1st day
Time frame: 1st day postoperative day
Rehabilitation process - bending range of motion- passive movement to 45 degrees- no pain- 2nd day
Time frame: 2nd day postoperative day
Rehabilitation process - bending range of motion- passive movement to 45 degrees- with pain- 2nd day
Time frame: 2nd day postoperative day
Rehabilitation process - bending range of motion- passive movement to 45 degrees- no pain- 5th day
Time frame: 5th day postoperative day
Rehabilitation process - bending range of motion- passive movement to 45 degrees- with pain- 5th day
Time frame: 5th day postoperative day
Rehabilitation process - bending range of motion- active movement to 90 degrees- no pain- 5th day
Time frame: 1st day postoperative day
Rehabilitation process - bending range of motion- active movement to 90 degrees- no pain- 2nd day
Time frame: 2nd day postoperative day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: Yes. The data presented in this study are available on request from the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Małgorzata Domagalska, PhD principal investigator
Department of Palliative Medicine, University of Medical Sciences, Poznań, Poland
Zbigniew Żaba, PhD study chair
Department of Emergency Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine 0.5% Injectable Solution 20mL and 0,9% normal saline 20mL in people with Knee Osteoarthritis and Knee Pain Chronic, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale [Range from 0:no pain to 10:the worst pain] (time frame: within 24 hours postoperatively). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.