Arthritis KneePhase 3NCT04910165

Exparel Use in Adductor Canal Block After Total Knee Arthroplasty

A Phase 3 study testing Exparel and Ropivacaine in people with Arthritis Knee and Pain, Postoperative, run by St. Luke's Hospital, Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Exparel has been shown to have better pain control compared to previously used infiltration agents, including bupivacaine, while having a minor side effect profile. The purpose of this study is to explore the effectiveness of Exparel (liposomal bupivacaine) in Adductor Canal Blocks for peri-operative pain control… Read more about this study

Who is it for?: Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for: Arthritis Knee, Pain, Postoperative, Opioid Use
What is being tested?: Exparel and Ropivacaine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 1 Jun 2020to 15 Oct 2021
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 99 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patients were eligible for inclusion if they were undergoing unilateral primary TKA for a diagnosis of knee osteoarthritis and were not undergoing any additional concomitant procedures were.

Who cannot join

Patients were not eligible for our study if they were undergoing revision TKA, if they were undergoing bilateral TKA or concomitant procedures, or if they had an active infection.

Trial locations and contacts

1 site in 1 country.

United States1 site

St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015

Other trials in United States

About this study

Official title: Adductor Canal Blocks Using Exparel for Pain Control After Total Knee Arthroplasty

Read the detailed description

The effectiveness of an Exparel Block (Bupivacaine Liposomal Injectable Suspension) for post-operative pain control has been well studied with encouraging results. At the investigators' institution, Exparel has been approved as a safe and effective option for use in shoulder surgeries and have had encouraging results in adductor canal use for pain control in patients undergoing TKA. Exparel has been shown to have better pain control compared to previously used infiltration agents, including bupivacaine, while having a minor side effect profile. The purpose of this study is to explore the effectiveness of Exparel (liposomal bupivacaine) in Adductor Canal Blocks (ACB) for peri-operative pain control following a total knee arthroplasty (TKA) procedure. Specifically, the investigators look to see if Exparel ACB reduces opioid requirement use post-operatively, reduces pain scores post-operatively, provides earlier mobilization, and decreases length of hospital stay.

Conditions: Arthritis Knee, Pain, Postoperative, Opioid Use
Being tested: Exparel, Ropivacaine
Keywords: Exparel, adductor, knee, arthroplasty, opioid
Medical subject headings: Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ExparelDrug
Exparel used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
RopivacaineDrug
Ropivacaine used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine

Study groups in NCT04910165
Study group	Role	What they receive
Exparel	Experimental	Liposomal Bupivacaine use as active ingredient in the block Receives: Drug: Exparel
Control	Active comparator	Ropivacaine use as active ingredient in the block Receives: Drug: Ropivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

Hospital Length of Stay
Inpatient post-operative stay after undergoing TKA procedure
Measured: Through entire inpatient hospital stay (lasted from 1 day to 1 week)
Inpatient Opioid Use
Opioid usage during their inpatient post-operative hospital stay
Measured: 1 week
Numeric Rating Scale (NRS) Pain Score Improvement
Measured with Numerical Rating Scale (Range: 0-10, Minimum:0, Maximum:10). Change in NRS Pain Score from pre-operative levels. Positive changes indicate a decrease in pain levels from pre-operative levels.
Measured: 6 weeks
Outpatient Opioid Use
Opioid usage in the immediate post-operative period after hospital discharge
Measured: 6 weeks
WOMAC Score
Western Ontario and McMaster Universities Osteoarthritis Index Patient Subjective Outcome Score (Range: 0-96, Minimum:0, Maximum:96). Subsections include Pain (Range:0-20, Minimum:0, Maximum:20), Stiffness (Range:0-8; Minimum:0, Maximum:8), and Functional Limitation (Range0-68, Minimum:0, Maximum:68). Measured as change in score from baseline levels. Positive scores indicate an improvement in WOMAC scores from pre-operative levels.
Measured: 6 weeks

Secondary outcomes (2)

Number of Participants Needing to be Readmitted to the Hospital Secondary to Inadequate Pain Control Post-operatively
Rate of needing to be readmitted to the hospital secondary to inadequate pain control post-operatively at any point during the study period.
Measured: 6 weeks
Number of Participants Needing to be Admitted to an Inpatient Rehabilitation Facility Post-Operatively
Rate of needing to be discharged to an inpatient rehabilitation facility after TKA procedure secondary to inadequate pain control and functional recovery
Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202015 Oct 2021

First posted2 Jun 2021
Study start1 Jun 2020
Primary completion15 Sep 2021
Study completion15 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Arthritis KneeStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04910165
Sponsor's protocol ID: SLIR 2019-106
Status last verified: May 2022
First submitted: 25 May 2021
Last updated: 20 May 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Arthritis Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adductor Canal Blocks Using Exparel for Pain Control After Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT04910165
Acronym / sponsor ID: SLIR 2019-106
Conditions: Arthritis Knee, Pain, Postoperative, Opioid Use
Keywords: Exparel, adductor, knee, arthroplasty, opioid
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: St. Luke's Hospital, PennsylvaniaUniversity, hospital or other
Study start: 1 Jun 2020 (actual)
Primary completion: 15 Sep 2021 (actual)
Study completion: 15 Oct 2021 (actual)
First posted: 2 Jun 2021 (actual)
Results: Posted 20 May 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
Exparel	Experimental	Drug: ExparelLiposomal Bupivacaine use as active ingredient in the block
Control	Active comparator	Drug: RopivacaineRopivacaine use as active ingredient in the block

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients were eligible for inclusion if they were undergoing unilateral primary TKA for a diagnosis of knee osteoarthritis and were not undergoing any additional concomitant procedures were.

Key exclusion criteria (1 listed)

Patients were not eligible for our study if they were undergoing revision TKA, if they were undergoing bilateral TKA or concomitant procedures, or if they had an active 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
ExparelExparel used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine	Drug	Exparel
RopivacaineRopivacaine used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine	Drug	Control

Primary outcome

Hospital Length of Stay
Time frame: Through entire inpatient hospital stay (lasted from 1 day to 1 week)
Inpatient post-operative stay after undergoing TKA procedure
Inpatient Opioid Use
Time frame: 1 week
Opioid usage during their inpatient post-operative hospital stay
Numeric Rating Scale (NRS) Pain Score Improvement
Time frame: 6 weeks
Measured with Numerical Rating Scale (Range: 0-10, Minimum:0, Maximum:10). Change in NRS Pain Score from pre-operative levels. Positive changes indicate a decrease in pain levels from pre-operative levels.
Outpatient Opioid Use
Time frame: 6 weeks
Opioid usage in the immediate post-operative period after hospital discharge
WOMAC Score
Time frame: 6 weeks
Western Ontario and McMaster Universities Osteoarthritis Index Patient Subjective Outcome Score (Range: 0-96, Minimum:0, Maximum:96). Subsections include Pain (Range:0-20, Minimum:0, Maximum:20), Stiffness (Range:0-8; Minimum:0, Maximum:8), and Functional Limitation (Range0-68, Minimum:0, Maximum:68). Measured as change in score from baseline levels. Positive scores indicate an improvement in WOMAC scores from pre-operative levels.

2 secondary outcomes

Number of Participants Needing to be Readmitted to the Hospital Secondary to Inadequate Pain Control Post-operatively
Time frame: 6 weeks
Number of Participants Needing to be Admitted to an Inpatient Rehabilitation Facility Post-Operatively
Time frame: 1 week

Results and safety

Results posted to the registry on 20 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exparel	50	50
Control	50	50

Primary outcome: Hospital Length of Stay

Time frame: Through entire inpatient hospital stay (lasted from 1 day to 1 week). Mean (Standard Deviation). Unit: Hours

Measure	Exparel n = 50	Control n = 50
Value	36.3 (12.4)	49.7 (35.3)

Exparel vs Control: p <0.05, Wilcoxon (Mann-Whitney)

Primary outcome: Inpatient Opioid Use

Time frame: 1 week. Mean (Standard Deviation). Unit: Milimorphine Equivalents/Day

Measure	Exparel n = 50	Control n = 50
Value	40.9 (20.7)	47.3 (27.9)

Exparel vs Control: p <0.05, Wilcoxon (Mann-Whitney)

Primary outcome: Numeric Rating Scale (NRS) Pain Score Improvement

Time frame: 6 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Exparel n = 50	Control n = 50
POD 0	1.8 (2.7)	-0.2 (2.7)
POD 1	1.0 (2.7)	-1.3 (2.4)
POD 2	2.3 (2.6)	-0.1 (2.3)
POD 7	1.8 (3.5)	0.2 (2.9)
POD 14	3.2 (3.2)	1.3 (3.0)
POD 28	3.9 (2.6)	2.2 (2.9)
POD 42	5.2 (2.7)	3.0 (2.5)

Exparel vs Control: p <0.05, Wilcoxon (Mann-Whitney)

Population analysed: Number of patients available in Post-operative day (POD) 2 lower secondary to earlier discharges. Number of patients available for analysis in in POD 7-42 time points secondary to their follow up). To account for this, both an "intention to treat" and a "per protocol" analysis were completed.

Primary outcome: Outpatient Opioid Use

Time frame: 6 weeks. Mean (Standard Deviation). Unit: Milimorphine Equivalents/Day

Measure	Exparel n = 50	Control n = 50
Value	33.4 (11.6)	32.1 (13.2)

Exparel vs Control: p <0.05, Wilcoxon (Mann-Whitney)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 17 months (June 2020-October 2021) Each patient was assessed for adverse events by direct history and physical exam by investigators at POD 0, POD 1, POD 2, POD 7, POD 14, POD 28, and POD 42.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exparel	0 of 50 (0%)	0 of 50 (0%)	0 of 50
Control	0 of 50 (0%)	4 of 50 (8%)	0 of 50

Limitations and caveats (from the sponsor): Block efficacy is dependent on the performing anesthesiologist, with multiple performing anesthesiologists introducing variability that was not accounted for. The use of drains was surgeon specific rather than part of our study protocol. The state's online drug monitoring program reports narcotic prescriptions filled but not necessarily taken possibly pointing to a discrepancy. Finally, all patients were obtained from one demographic area, and all surgeries were only performed by two surgeons

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Chinenye Nwachuku, MD principal investigator

St. Luke's Hospital and Health Network, Pennsylvania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Exparel and Ropivacaine in people with Arthritis Knee and Pain, Postoperative, run by St. Luke's Hospital, Pennsylvania 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 20 May 2022. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Hospital Length of Stay (time frame: Through entire inpatient hospital stay (lasted from 1 day to 1 week)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04910165.

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 20 May 2022.