PainPhase 4NCT02284386
Pharmacokinetics and Safety of Bupivacaine HCl Spinal Block and EXPAREL Local Infiltration in Total Knee Arthroplasty
A Phase 4 study testing Bupivacaine SNB and EXPAREL Infiltration in people with Pain, run by Pacira Pharmaceuticals, Inc at 2 sites in United States.
Trial summary
This is a Phase 4, multicenter, open-label study designed to characterize the pharmacokinetic (PK) profile of total bupivacaine in approximately 15 adult subjects undergoing primary unilateral total knee arthroplasty (TKA) with bupivacaine hydrochloride (HCl) spinal nerve block (SNB) and EXPAREL local infiltration… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Bupivacaine SNB and EXPAREL Infiltration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2014to Mar 2015
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females ≥18 years of age.
- American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.
- Scheduled to undergo spinal block in conjunction with unilateral TKA.
- Female subjects must be surgically sterile, at least 2 years postmenopausal, or using a medically acceptable method of birth control. Females of childbearing potential must have a documented negative blood or urine pregnancy test result within 24 hours before surgery.
- Able to provide informed consent, adhere to the study schedule, and complete all study assessments.
Who cannot join
- History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics or opioids.
- Contraindication to bupivacaine.
- Received bupivacaine or any other local anesthetic within 7 days of EXPAREL administration.
- Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after EXPAREL administration.
- Planned concurrent surgical procedure (e.g., bilateral TKA).
- Body weight <50 kg (110 pounds) or a body mass index ≥45 kg/m2.
Show all 13Show fewer
- Received any investigational drug within 30 days prior to EXPAREL administration, and/or has planned administration of another investigational product or procedure during the subject's participation in this study.
- Previous participation in an EXPAREL study.
- Malignancy in the last 2 years, with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
- Current or historical evidence of any clinically significant disease or condition, especially cardiovascular or neurological conditions that, in the opinion of the Investigator, may increase the risk of surgery or complicate the subject's postsurgical course.
- Clinically significant medical or psychiatric disease that, in the opinion of the Investigator, would constitute a contraindication to participation in the study, or cause inability to comply with the study requirements.
- In addition, the subject will be ineligible to receive EXPAREL if he or she meets the following criteria during surgery:
- Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postsurgical course.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Minnesota Medical Center - Fairview, West Bank
Minneapolis, Minnesota, 55455
Shaols Medical Trials, Inc.
Sheffield, Alabama, 35660
About this study
Official title: Evaluation of the Pharmacokinetics and Safety of Bupivacaine HCl Spinal Block and EXPAREL Local Infiltration in Subjects Undergoing for Unilateral Total Knee Arthroplasty
This is a Phase 4, multicenter, open-label study designed to characterize the pharmacokinetic (PK) profile of total bupivacaine in approximately 15 adult subjects undergoing primary unilateral total knee arthroplasty (TKA) with bupivacaine hydrochloride (HCl) spinal nerve block (SNB) and EXPAREL local infiltration into the surgical site.
Read the detailed description
On Day 1, following an epinephrine "wash" of the spinal block syringe, eligible subjects will receive a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure as a spinal block. EXPAREL 266 mg in 20 mL (expanded with 70 mL of preservative-free sterile normal saline to a total volume of 90 mL) will be infiltrated into the surgical site at the end of the surgery prior to wound closure. There will be no local co-administration of the two drugs.
Blood samples for bupivacaine PK analysis will be obtained from subjects at baseline (prior to bupivacaine HCl administration for nerve block), 15 minutes, 30 minutes, and 1, 2, 4, 8, 12, 24, 48, and 72 hours after the beginning of EXPAREL administration, and on Day 14.
- Conditions
- Pain
- Being tested
- Bupivacaine SNB, EXPAREL Infiltration
- Keywords
- Total knee arthroplasty
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine SNBDrug
Also called Bupivacaine
SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.
EXPAREL InfiltrationDrug
Also called Bupivacaine
Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine SNB + EXPAREL Infiltration | Experimental | Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg. Receives: Drug: Bupivacaine SNB; Drug: EXPAREL Infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax)
Measured: baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14
Time to Peak Plasma Concentration (Tmax)
Measured: baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14
Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Last Collection Time After Drug Administration (AUC0-last)
Measured: baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14
Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity After Drug Administration (AUC0-∞)
Measured: baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14
The Apparent Terminal Elimination Rate Constant (λz)
Measured: baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14
The Apparent Terminal Elimination Half-life (t1/2el)
Measured: baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2015
- Study completionMar 2015
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 PainStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacob Hutchins, MD, Principal investigator, University of Minnesoty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284386
- Sponsor's protocol ID
- 402-C-405
- Status last verified
- Feb 2021
- First submitted
- 3 Nov 2014
- Last updated
- 8 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Pharmacokinetics and Safety of Bupivacaine HCl Spinal Block and EXPAREL Local Infiltration in Subjects Undergoing for Unilateral Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02284386
- Acronym / sponsor ID
- 402-C-405
- Conditions
- Pain
- Keywords
- Total knee arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 6 Nov 2014 (estimated)
- Results
- Posted 28 Jun 2016
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 Phase 4, multicenter, open-label study designed to characterize the pharmacokinetic (PK) profile of total bupivacaine in approximately 15 adult subjects undergoing primary unilateral total knee arthroplasty (TKA) with bupivacaine hydrochloride (HCl) spinal nerve block (SNB) and EXPAREL local infiltration into the surgical site.
Detailed description
On Day 1, following an epinephrine "wash" of the spinal block syringe, eligible subjects will receive a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure as a spinal block. EXPAREL 266 mg in 20 mL (expanded with 70 mL of preservative-free sterile normal saline to a total volume of 90 mL) will be infiltrated into the surgical site at the end of the surgery prior to wound closure. There will be no local co-administration of the two drugs.
Blood samples for bupivacaine PK analysis will be obtained from subjects at baseline (prior to bupivacaine HCl administration for nerve block), 15 minutes, 30 minutes, and 1, 2, 4, 8, 12, 24, 48, and 72 hours after the beginning of EXPAREL administration, and on Day 14.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine SNB + EXPAREL Infiltration | Experimental | Drug: Bupivacaine SNB, Drug: EXPAREL InfiltrationSpinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females ≥18 years of age.
- American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.
- Scheduled to undergo spinal block in conjunction with unilateral TKA.
- Female subjects must be surgically sterile, at least 2 years postmenopausal, or using a medically acceptable method of birth control. Females of childbearing potential must have a documented negative blood or urine pregnancy test result within 24 hours before surgery.
- Able to provide informed consent, adhere to the study schedule, and complete all study assessments.
Key exclusion criteria (13 listed)
- History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics or opioids.
- Contraindication to bupivacaine.
- Received bupivacaine or any other local anesthetic within 7 days of EXPAREL administration.
- Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after EXPAREL administration.
- Planned concurrent surgical procedure (e.g., bilateral TKA).
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 |
|---|---|---|
| Bupivacaine SNBAlso: BupivacaineSNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure. | Drug | Bupivacaine SNB + EXPAREL Infiltration |
| EXPAREL InfiltrationAlso: BupivacaineLocal infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure. | Drug | Bupivacaine SNB + EXPAREL Infiltration |
Primary outcome
Maximum Plasma Concentration (Cmax)
Time frame: baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14
Time to Peak Plasma Concentration (Tmax)
Time frame: baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14
Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Last Collection Time After Drug Administration (AUC0-last)
Time frame: baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14
Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity After Drug Administration (AUC0-∞)
Time frame: baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14
The Apparent Terminal Elimination Rate Constant (λz)
Time frame: baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14
The Apparent Terminal Elimination Half-life (t1/2el)
Time frame: baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jacob Hutchins, MD principal investigator
University of Minnesoty
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine SNB and EXPAREL Infiltration in people with Pain, run by Pacira Pharmaceuticals, Inc at 2 sites 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 13 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 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 28 Jun 2016). 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?
Maximum Plasma Concentration (Cmax) (time frame: baseline, 15,30 min, 1,2,4,8,12,24,48,72 hours post dose, day 14). The study lists 6 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 8 Mar 2021.