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WithdrawnNCT03954639STRIDEUpdated Aug 13, 2020

Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL Admixed With Bupi vs. Bupi Only Administered as Combined Sciatic and Adductor Canal Nerve Block for Postsurgical Analgesia in Lower Extremity Surgeries

A Phase 3 interventional study of EXPAREL 13.3Mg/mL Suspension for Injection and Bupivacaine Hydrochloride in Bunion, Metatarsophalangeal Fusion and Midfoot Fusion, sponsored by Pacira Pharmaceuticals, Inc. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-13.

Sponsored by Pacira Pharmaceuticals, Inc · Phase 3, Interventional, and Treatment

Why this study was withdrawn
Sponsor Decision.
Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 81 subjects undergoing lower extremity surgeries with combined sciatic and adductor canal nerve block.

02

Conditions studied

  • Bunion
  • Metatarsophalangeal Fusion
  • Midfoot Fusion
  • Hindfoot Fusion
  • Total Ankle Arthroplasty
  • Forefoot Surgery

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03

In context

Bunion

58 studies on the registry are indexed under Bunion; 5 are open to participants now.

Browse Bunion studies →

Lead sponsor

Pacira Pharmaceuticals, Inc is the lead sponsor of 102 studies on the registry; 3 are open to participants now.

Of its 26 completed or terminated interventional studies of FDA-regulated products, 17 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy adult male or female volunteers ages 18 or older
  2. (ASA) physical status 1, 2 or 3.
  3. Able to provide , adhere to the study schedule, and complete all study assessments.
  4. ≥18 and ≤40 kg/m2

Exclusion criteria

Exclusion Criteria:

  1. Allergy, , intolerance, or to any of the study medications for which an alternative is not named in the protocol (eg, amide-type local anesthetics, opioids, bupivacaine, NSAIDs)
  2. Documented history of long-term diabetes, renal (serum creatinine level >2mg/dL [176.8 μmol/L]) or hepatic dysfunction (serum alanine or aspartame transferase > 3 times the ), coagulation or bleeding disorder and severe peripheral vascular disease
  3. Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the post dosing period for pain and which, in the investigator's opinion may confound the post dosing assessments
  4. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
  5. Administration of an drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
  6. Previous participation in EXPAREL study
  7. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance
  8. Currently pregnant, nursing, or planning to become pregnant during the study
  9. medical disease that, in the opinion of the investigator, would make participation in a clinical study inappropriate. This includes any psychiatric or other conditions that would constitute a contraindication to participation in the study
  10. Currently on neuroleptic agent [e.g., gabapentin, pregabalin (Lyrica), duloxetine (Cymbalta) etc.]
  11. Inadequate sensory function on the foot (monofilament test)
  12. Chronic opioid use in the last 30 days (≥30 morphine equivalents/ day)

    In addition, the subject may be withdrawn from the study if the subject meets the following criterion during or post-surgery:

  13. Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that, in the opinion of the investigator, renders the subject medically unstable or complicates the subject's post-operative course
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Cohort 1, Group 1

    Subjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with EXPAREL. EXPAREL will be mixed with Bupivacaine Subjects enrolled in Cohort 1 will provide blood samples and measures for efficacy and safety.

    Drug: EXPAREL 13.3Mg/mL Suspension for Injection

  • Active comparator
    Cohort 1, Group 2

    Subjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with bupivacaine. Subjects enrolled in Cohort 1 will provide blood samples and measures for efficacy and safety.

    Drug: Bupivacaine Hydrochloride

  • Experimental
    Cohort 2, Group 1

    Subjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with EXPAREL. EXPAREL will be mixed with Bupivacaine Subjects enrolled in Cohort 2 will provide measures for efficacy and safety.

    Drug: EXPAREL 13.3Mg/mL Suspension for Injection

  • Active comparator
    Cohort 2, Group 2

    Subjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with bupivacaine. Subjects enrolled in Cohort 2 will provide measures for efficacy and safety.

    Drug: Bupivacaine Hydrochloride

Interventions

  • DrugEXPAREL 13.3Mg/mL Suspension for Injection

    Drug page: Liposomal Bupivacaine

    Combined Sciatic and Adductor Canal Nerve Block with EXPAREL mixed with Bupivacaine (Single Dose)

  • Combined Sciatic and Adductor Canal Nerve Block with Bupivacaine HCL

06

What researchers measure

Primary outcomes

  1. Magnitude of analgesic effect

    Area under the Curve of the NRS Pain intensity scores from 0 hours to 96 hours post-surgery.

    Time frame: 0 hours to 96 hours

Secondary outcomes

  1. Total Postsurgical Opioid Consumption

    Total Postsurgical opioid consumption from 0 hours to 96 hours post-surgery

    Time frame: 0 hours to 96 hours

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03954639
Responsible party
Sponsor
First posted
May 17, 2019
Start date
Jun 15, 2020 (estimated)
Primary completion
Sep 2020 (estimated)
Completion
Sep 2020 (estimated)
Last update
Aug 13, 2020

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Liposomal Bupivacaine

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