Pain, PostoperativePhase 4NCT06619340
EXPAREL IPSA Block in Knee Arthroplasty
A Phase 4 study testing Exparel in people with Pain, Postoperative and Osteo Arthritis Knee, run by Campbell Clinic at 1 site in United States.
Trial summary
This is a case series to assess the clinical utility of an Intra-articular Posteromedial Surgeon Administered (IPSA) Block in patients undergoing primary unilateral total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Osteo Arthritis Knee
- What is being tested?
- Exparel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2024to 31 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indicated to undergo primary unilateral total knee arthroplasty under spinal anesthesia.
- Primary indication for TKA is degenerative osteoarthritis of the knee.
- American Society of Anesthesiologists physical status 1, 2, or 3.
- Able to provide informed consent, adhere to study schedule, and complete all study assessments.
- Body Mass Index (BMI) > 18 and < 40 kg/m2.
Who cannot join
- Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine HCL, non-steroidal anti-inflammatory drugs (NSAIDs)).
- Planned concurrent surgical procedure (e.g., bilateral TKA).
- Undergoing unicompartmental TKA or revision TKA.
- Concurrent painful physical condition (e.g. arthritis, fibromyalgia, cancer) that may require analgesic treatment with NSAIDs or opioids in the post dosing period for pain that is not strictly related to the knee surgery and which, in the Investigator's opinion, may confound the post dosing assessments.
- Previous open knee surgery on the knee being considered for TKA. Prior arthroscopy is permitted.
- History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
Show all 10Show fewer
- Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, could interfere with study assessments or compliance.
- Currently pregnant, nursing, or planning to become pregnant during the study.
- Clinically significant medical disease that, in the opinion of the Investigator, would make participation in a clinical study inappropriate. This includes diabetic neuropathy, coagulation or bleeding disorders, severe peripheral vascular disease, renal insufficiency, hepatic dysfunction or other conditions that would constitute a contraindication to participation in the study.
- Chronic opioid use (average ≥30 oral morphine equivalents/day) within 30 days prior to surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Case Series Assessing the Clinical Utility of EXPAREL As an Intra-articular Posteromedial Surgeon Administered (IPSA) Block in Patients Undergoing Primary Unilateral Total Knee Arthroplasty
This is a case series to assess the clinical utility of an Intra-articular Posteromedial Surgeon Administered (IPSA) Block in patients undergoing primary unilateral total knee arthroplasty.
Read the detailed description
EXPAREL is approved by the Food and Drug Administration (FDA) for use in adults to produce postsurgical regional analgesia via an adductor canal block. The purpose of this study is to evaluate the clinical utility of a surgeon administered EXPAREL adductor canal block intraoperatively in patients undergoing primary unilateral total knee arthroplasty (TKA).
Patients will not be randomized - all patients will receive an EXPAREL IPSA block intraoperatively. Visual Analog Scale, patient reported outcomes, and patient's satisfaction with pain management will be recorded. Adverse events will be monitored.
- Conditions
- Pain, Postoperative, Osteo Arthritis Knee
- Being tested
- Exparel
- 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
20 milliliter (mL) EXPAREL with 20mL bupivacaine hydrochloride (HCL) 0.5% will be expanded. An 18-gauge bevel needle will be introduced through the capsular pocket at 1 to 2cm proximal to the adductor tubercle at the proximal border of the posteromedial femoral condyle. The needle will be angled proximally and posteriorly, and then advanced to contact the posteromedial capsule. A 20mL bolus of the study drug admixture will be administered. The remaining 20mL of the study drug admixture will be administered to the anterior and lateral knee structures with approximately 1 to 1.5mL administered with each stick to the intended area.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Patients will receive an EXPAREL IPSA block intraoperatively. Receives: Drug: Exparel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Assessment - 24hr recall
On a 0-10 scale, record worst pain in the last 24 hours and average pain in the last 24 hours, with 0 being no pain at all and 10 being the worst pain possible.
Measured: Study Enrollment, Post-operative Day 1, Post-operative Day 2, Post-operative Day 3, Post-operative Day 14, Post-operative Day 42
Pain Assessment - current pain
On a 0-10 scale, record current pain level, with 0 being no pain at all and 10 being the worst pain possible.
Measured: Study Enrollment, On Admission to Surgery, on Post Anesthesia Care Unit (PACU) Admission, every 15 minutes from PACU admission to discharge home, 12 hours after surgery, Post-operative Day (POD) 1, POD 2, POD 3, POD 14, POD 42
Secondary outcomes (4)
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement
Patient reported outcome on overall knee health where 0 represents total knee disability and 100 represents perfect knee health.
Measured: Enrollment, Post-operative Day 14, Post-operative Day 42
Forgotten Joint Score
Patient reported outcome on patient's awareness of their artificial joint. The higher the score, the less aware the patient is about their joint during activities of daily living.
Measured: Post-operative Day 14, Post-operative Day 42
Breakthrough Pain Assessment
On a 0-10 scale, record current pain score before administration of breakthrough pain medication in PACU where 0 represents no pain at all and 10 represents worst pain possible.
Measured: In PACU before administration of breakthrough pain medication
Patient Satisfaction with Pain Management
On a 0-10 scale, record patient's satisfaction with pain management where 0 represents not satisfied at all and 10 represents very satisfied.
Measured: 12 hours after surgery, Post-operative Day 14, Post-operative Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start20 May 2024
- Primary completion20 May 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Campbell Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William M. Mihalko, Campbell Clinic
- Investigators
- William Mihalko, MD, PhD, Principal investigator, Campbell Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619340
- Sponsor's protocol ID
- 24-10012-XP
- Status last verified
- Sep 2024
- First submitted
- 24 Jul 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case Series Assessing the Clinical Utility of EXPAREL As an Intra-articular Posteromedial Surgeon Administered (IPSA) Block in Patients Undergoing Primary Unilateral Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06619340
- Acronym / sponsor ID
- 24-10012-XP
- Conditions
- Pain, Postoperative, Osteo Arthritis Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Campbell ClinicUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 20 May 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Oct 2024 (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 is a case series to assess the clinical utility of an Intra-articular Posteromedial Surgeon Administered (IPSA) Block in patients undergoing primary unilateral total knee arthroplasty.
Detailed description
EXPAREL is approved by the Food and Drug Administration (FDA) for use in adults to produce postsurgical regional analgesia via an adductor canal block. The purpose of this study is to evaluate the clinical utility of a surgeon administered EXPAREL adductor canal block intraoperatively in patients undergoing primary unilateral total knee arthroplasty (TKA).
Patients will not be randomized - all patients will receive an EXPAREL IPSA block intraoperatively. Visual Analog Scale, patient reported outcomes, and patient's satisfaction with pain management will be recorded. Adverse events will be monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: ExparelPatients will receive an EXPAREL IPSA block intraoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Indicated to undergo primary unilateral total knee arthroplasty under spinal anesthesia.
- Primary indication for TKA is degenerative osteoarthritis of the knee.
- American Society of Anesthesiologists physical status 1, 2, or 3.
- Able to provide informed consent, adhere to study schedule, and complete all study assessments.
- Body Mass Index (BMI) > 18 and < 40 kg/m2.
Key exclusion criteria (10 listed)
- Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine HCL, non-steroidal anti-inflammatory drugs (NSAIDs)).
- Planned concurrent surgical procedure (e.g., bilateral TKA).
- Undergoing unicompartmental TKA or revision TKA.
- Concurrent painful physical condition (e.g. arthritis, fibromyalgia, cancer) that may require analgesic treatment with NSAIDs or opioids in the post dosing period for pain that is not strictly related to the knee surgery and which, in the Investigator's opinion, may confound the post dosing assessments.
- Previous open knee surgery on the knee being considered for TKA. Prior arthroscopy is permitted.
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 |
|---|---|---|
| Exparel20 milliliter (mL) EXPAREL with 20mL bupivacaine hydrochloride (HCL) 0.5% will be expanded. An 18-gauge bevel needle will be introduced through the capsular pocket at 1 to 2cm proximal to the adductor tubercle at the proximal border of the posteromedial femoral condyle. The needle will be angled proximally and posteriorly, and then advanced to contact the posteromedial capsule. A 20mL bolus of the study drug admixture will be administered. The remaining 20mL of the study drug admixture will be administered to the anterior and lateral knee structures with approximately 1 to 1.5mL administered with each stick to the intended area. | Drug | Experimental Group |
Primary outcome
Pain Assessment - 24hr recall
Time frame: Study Enrollment, Post-operative Day 1, Post-operative Day 2, Post-operative Day 3, Post-operative Day 14, Post-operative Day 42
On a 0-10 scale, record worst pain in the last 24 hours and average pain in the last 24 hours, with 0 being no pain at all and 10 being the worst pain possible.
Pain Assessment - current pain
Time frame: Study Enrollment, On Admission to Surgery, on Post Anesthesia Care Unit (PACU) Admission, every 15 minutes from PACU admission to discharge home, 12 hours after surgery, Post-operative Day (POD) 1, POD 2, POD 3, POD 14, POD 42
On a 0-10 scale, record current pain level, with 0 being no pain at all and 10 being the worst pain possible.
4 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement
Time frame: Enrollment, Post-operative Day 14, Post-operative Day 42
Forgotten Joint Score
Time frame: Post-operative Day 14, Post-operative Day 42
Breakthrough Pain Assessment
Time frame: In PACU before administration of breakthrough pain medication
Patient Satisfaction with Pain Management
Time frame: 12 hours after surgery, Post-operative Day 14, Post-operative Day 42
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- 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.
William Mihalko, MD, PhD principal investigator
Campbell Clinic
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 Exparel in people with Pain, Postoperative and Osteo Arthritis Knee, run by Campbell Clinic 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 5 inclusion and 10 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 1 Oct 2024. 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 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?
Pain Assessment - 24hr recall (time frame: Study Enrollment, Post-operative Day 1, Post-operative Day 2, Post-operative Day 3, Post-operative Day 14, Post-operative Day 42). The study lists 2 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 1 Oct 2024.