Knee ArthropathyNCT04292392
Pain Levels and Opioid Usage in Three Nerve Block Cohorts in Primary TKA
A study testing preop ACB, followed by Intra-articular block during TKA surgery, preop ACB+IPACK block and preop ACB+IPACK block, followed by Intra-articular block during TKA surgery in people with Knee Arthropathy, run by University of Louisville at 1 site in United States.
Trial summary
The primary objective of this study is to compare effect of combined block of ACB (adductor canal block) with IPACK (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) block and/or Intra-articular block in immediate postoperative and early postop rehabilitation and pain management in… Read more about this study
- Who is it for?
- Ages 22 to 89 years
- Conditions the study is for
- Knee Arthropathy
- What is being tested?
- preop ACB, followed by Intra-articular block during TKA surgery, preop ACB+IPACK block and preop ACB+IPACK block, followed by Intra-articular block during TKA surgery
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2020to 30 Sep 2020
- Phase
- Interventional
- 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 22 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is indicated for a primary, unilateral TKA secondary to osteoarthritis.
- Patient age is 22-89 at time of TKA surgery.
- Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document.
- Patient is able to read and speak English.
Who cannot join
- Patient is under the age of 22 or over the age of 89.
- Patient's primary diagnosis is not osteoarthritis (e.g. post-traumatic arthritis).
- Patient is scheduled to undergo a bilateral TKA surgery.
- Patient is unable to read and speak English.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Pain Levels and Opioid Usage in ACB + Periarticular Block vs. ACB + IPACK Block vs. ACB + IPACK + Periarticular Block in Patients Undergoing Primary TKA
The primary objective of this study is to compare effect of combined block of ACB (adductor canal block) with IPACK (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) block and/or Intra-articular block in immediate postoperative and early postop rehabilitation and pain management in patients undergoing primary TKA. The secondary objective is to review both in-hospital and post-discharge pain levels and narcotic usage of primary TKAs, with a minimum 6-week postoperative follow-up.
- Conditions
- Knee Arthropathy
- Being tested
- preop ACB, followed by Intra-articular block during TKA surgery, preop ACB+IPACK block, preop ACB+IPACK block, followed by Intra-articular block during TKA surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preop ACB, followed by Intra-articular block during TKA surgeryOther
Preoperative ACB (adductor canal block), followed by a local anesthetic injection during surgery, which is comprised of the following agents and amounts:
- Ropivacaine 5mg/ml (49.25ml)
- Epinephrine 1mg/ml (0.5ml)
- Ketorolac 30mg/ml (1ml)
- Clonidine 0.1mg/ml (0.8ml)
- Saline 48.45ml
preop ACB+IPACK blockOther
Preoperative ACB (adductor canal block) and IPACK (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) block
preop ACB+IPACK block, followed by Intra-articular block during TKA surgeryOther
Preoperative ACB (adductor canal block) and IPACK (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) block, followed by a local anesthetic injection during surgery, which is comprised of the following agents and amounts:
- Ropivacaine 5mg/ml (49.25ml)
- Epinephrine 1mg/ml (0.5ml)
- Ketorolac 30mg/ml (1ml)
- Clonidine 0.1mg/ml (0.8ml)
- Saline 48.45ml
| Study group | Role | What they receive |
|---|---|---|
| A - ACB + Periarticular Block | Experimental | Group A: patient will receive a preop ACB, followed by Intra-articular block during TKA surgery Receives: Other: preop ACB, followed by Intra-articular block during TKA surgery |
| B - ACB + IPACK Block | Experimental | Group B: patient will receive a preop ACB+IPACK block before TKA surgery only Receives: Other: preop ACB+IPACK block |
| C - ACB + IPACK + Periarticular Block | Experimental | Group C: patient will receive a preop ACB+IPACK block, followed by Intra-articular block during TKA surgery Receives: Other: preop ACB+IPACK block, followed by Intra-articular block during TKA surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
total length of hospital stay
total length of hospital stay as defined by number of days from date of surgery to date of discharge
Measured: outcome measure will be taken at 2 weeks postoperatively
Knee Society Score
Knee Society Score as recorded preoperatively and 6 weeks (± 2 weeks) postoperatively. The score is on a scale from 0-100. A higher value represents a better outcome
Measured: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery) and 6 weeks (± 2 weeks) postoperatively.]
WOMAC score
WOMAC score as recorded preoperatively and 6 weeks (± 2 weeks) postoperatively. The score is on a scale from 0-100. In contrast to the Knee Society Score, on the WOMAC a lower value represents a better outcome.
Measured: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery) and 6 weeks (± 2 weeks) postoperatively
Visual Analog Scale
The Visual Analog Scale measures the patient's level of knee pain on a scale of zero to ten via what the patient expresses verbally. The Visual Analog Scale (VAS) represents the degree of pain that the patient is experiencing at the time the measure is taken. Zero represents "pain-free". A 10 would represent pain so excruciating as to warrant emergency medical assistance, or as it is described to the patient, "the worst pain imaginable". Obviously, the lower the number, the better the outcome. There is no subscale.
Measured: outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, and 6 weeks (± 2 weeks) postoperatively
Amount of narcotic medication utilized
Amount of narcotic medication utilized (daily dosage measured as a Milligram Morphine Equivalent (MME) value).
Measured: outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, and 6 weeks (± 2 weeks) postoperatively
Ability to rise from a chair independently
Ability to rise from a chair independently (Yes/No)
Measured: outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, and 6 weeks (± 2 weeks) postoperatively
Active range-of-motion (ROM)
Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)
Measured: outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, and 6 weeks (± 2 weeks) postoperatively
Distance that patient is able to walk
Distance that patient is able to walk, as measured in feet
Measured: outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, and 6 weeks (± 2 weeks) postoperatively
Use of an ambulatory assistive device
Use of an ambulatory assistive device (Yes/No)
Measured: outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, 6 weeks (± 2 weeks) postoperatively
Incidence of postop complications
Incidence of any postoperative complication that involves hospital readmission and/or a re-operation of the surgical knee.
Measured: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start6 Apr 2020
- Primary completion15 Aug 2020
- Study completion30 Sep 2020
Why it stopped: Final protocol and ICF has not been approved by local IRB. No subjects have been enrolled. Study will not be pursued due to current COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthropathyStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arthur Malkani, University of Louisville
- Investigators
- Arthur L Malkani, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292392
- Sponsor's protocol ID
- 20.0132
- Status last verified
- Nov 2020
- First submitted
- 28 Feb 2020
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pain Levels and Opioid Usage in ACB + Periarticular Block vs. ACB + IPACK Block vs. ACB + IPACK + Periarticular Block in Patients Undergoing Primary TKA
- ClinicalTrials.gov ID
- NCT04292392
- Acronym / sponsor ID
- 20.0132
- Conditions
- Knee Arthropathy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Final protocol and ICF has not been approved by local IRB. No subjects have been enrolled. Study will not be pursued due to current COVID-19 pandemic.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 6 Apr 2020 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 3 Mar 2020 (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.
The primary objective of this study is to compare effect of combined block of ACB (adductor canal block) with IPACK (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) block and/or Intra-articular block in immediate postoperative and early postop rehabilitation and pain management in patients undergoing primary TKA. The secondary objective is to review both in-hospital and post-discharge pain levels and narcotic usage of primary TKAs, with a minimum 6-week postoperative follow-up.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A - ACB + Periarticular Block | Experimental | Other: preop ACB, followed by Intra-articular block during TKA surgeryGroup A: patient will receive a preop ACB, followed by Intra-articular block during TKA surgery |
| B - ACB + IPACK Block | Experimental | Other: preop ACB+IPACK blockGroup B: patient will receive a preop ACB+IPACK block before TKA surgery only |
| C - ACB + IPACK + Periarticular Block | Experimental | Other: preop ACB+IPACK block, followed by Intra-articular block during TKA surgeryGroup C: patient will receive a preop ACB+IPACK block, followed by Intra-articular block during TKA surgery |
Who may qualify
- Ages
- 22 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is indicated for a primary, unilateral TKA secondary to osteoarthritis.
- Patient age is 22-89 at time of TKA surgery.
- Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document.
- Patient is able to read and speak English.
Key exclusion criteria (4 listed)
- Patient is under the age of 22 or over the age of 89.
- Patient's primary diagnosis is not osteoarthritis (e.g. post-traumatic arthritis).
- Patient is scheduled to undergo a bilateral TKA surgery.
- Patient is unable to read and speak English.
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 |
|---|---|---|
| preop ACB, followed by Intra-articular block during TKA surgeryPreoperative ACB (adductor canal block), followed by a local anesthetic injection during surgery, which is comprised of the following agents and amounts: * Ropivacaine 5mg/ml (49.25ml) * Epinephrine 1mg/ml (0.5ml) * Ketorolac 30mg/ml (1ml) * Clonidine 0.1mg/ml (0.8ml) * Saline 48.45ml | Other | A - ACB + Periarticular Block |
| preop ACB+IPACK blockPreoperative ACB (adductor canal block) and IPACK (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) block | Other | B - ACB + IPACK Block |
| preop ACB+IPACK block, followed by Intra-articular block during TKA surgeryPreoperative ACB (adductor canal block) and IPACK (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) block, followed by a local anesthetic injection during surgery, which is comprised of the following agents and amounts: * Ropivacaine 5mg/ml (49.25ml) * Epinephrine 1mg/ml (0.5ml) * Ketorolac 30mg/ml (1ml) * Clonidine 0.1mg/ml (0.8ml) * Saline 48.45ml | Other | C - ACB + IPACK + Periarticular Block |
Primary outcome
total length of hospital stay
Time frame: outcome measure will be taken at 2 weeks postoperatively
total length of hospital stay as defined by number of days from date of surgery to date of discharge
Knee Society Score
Time frame: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery) and 6 weeks (± 2 weeks) postoperatively.]
Knee Society Score as recorded preoperatively and 6 weeks (± 2 weeks) postoperatively. The score is on a scale from 0-100. A higher value represents a better outcome
WOMAC score
Time frame: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery) and 6 weeks (± 2 weeks) postoperatively
WOMAC score as recorded preoperatively and 6 weeks (± 2 weeks) postoperatively. The score is on a scale from 0-100. In contrast to the Knee Society Score, on the WOMAC a lower value represents a better outcome.
Visual Analog Scale
Time frame: outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, and 6 weeks (± 2 weeks) postoperatively
The Visual Analog Scale measures the patient's level of knee pain on a scale of zero to ten via what the patient expresses verbally. The Visual Analog Scale (VAS) represents the degree of pain that the patient is experiencing at the time the measure is taken. Zero represents "pain-free". A 10 would represent pain so excruciating as to warrant emergency medical assistance, or as it is described to the patient, "the worst pain imaginable". Obviously, the lower the number, the better the outcome. There is no subscale.
Amount of narcotic medication utilized
Time frame: outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, and 6 weeks (± 2 weeks) postoperatively
Amount of narcotic medication utilized (daily dosage measured as a Milligram Morphine Equivalent (MME) value).
Ability to rise from a chair independently
Time frame: outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, and 6 weeks (± 2 weeks) postoperatively
Ability to rise from a chair independently (Yes/No)
Active range-of-motion (ROM)
Time frame: outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, and 6 weeks (± 2 weeks) postoperatively
Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)
Distance that patient is able to walk
Time frame: outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, and 6 weeks (± 2 weeks) postoperatively
Distance that patient is able to walk, as measured in feet
Use of an ambulatory assistive device
Time frame: outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, 6 weeks (± 2 weeks) postoperatively
Use of an ambulatory assistive device (Yes/No)
Incidence of postop complications
Time frame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Incidence of any postoperative complication that involves hospital readmission and/or a re-operation of the surgical knee.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Arthur L Malkani, MD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preop ACB, followed by Intra-articular block during TKA surgery, preop ACB+IPACK block and preop ACB+IPACK block, followed by Intra-articular block during TKA surgery in people with Knee Arthropathy, run by University of Louisville at 1 site in United States.
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 4 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: withdrawn, as of the sponsor's last update on 4 Nov 2020. 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 United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
total length of hospital stay (time frame: outcome measure will be taken at 2 weeks postoperatively). The study lists 10 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 4 Nov 2020.