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CompletedNCT04002089Updated Jan 11, 2021

Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety, of EXPAREL Administered as Sciatic Nerve Block (In Popliteal Fossa), for Postsurgical Analgesia in Subjects Undergoing Bunionectomy

A Phase 1 interventional study of Exparel Injectable Product and Bupivacaine in Bunion, sponsored by Pacira Pharmaceuticals, Inc. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-11.

Sponsored by Pacira Pharmaceuticals, Inc · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
45
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a pilot, open label, single center study in 40 subjects undergoing bunionectomy. The study will assess and collect information on pharmacokinetics, pharmacodynamics, safety and efficacy of EXPAREL administered as a sciatic nerve block (in popliteal fossa).

A total of 10 subjects will be enrolled in each of the 4 cohorts.

02

Conditions studied

  • Bunion

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03

Who can participate

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Allergy, hypersensitivity, intolerance, or contraindication 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 or severe peripheral vascular disease
  3. Renal (serum creatinine level >2mg/dL [176.8 μmol/L]) or hepatic dysfunction (serum alanine or aspartame transferase > 3 times the upper limit of normal).
  4. 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
  5. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
  6. Administration of an investigational 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
  7. Previous participation in an EXPAREL study
  8. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance
  9. Currently pregnant, nursing, or planning to become pregnant during the study
  10. Clinically significant 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
  11. Currently on neuroleptic agent [e.g., gabapentin, pregabalin (Lyrica), duloxetine (Cymbalta) etc.]
  12. Inadequate sensory function on the foot (monofilament test)

  13. 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:

  14. 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
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Cohort 1 - EXPAREL

    A total of 10 subjects will be enrolled. Subjects in this cohort will receive 266mg of EXPAREL admixed with bupivacaine.

    Drug: Exparel Injectable Product · Drug: Bupivacaine

  • Experimental
    Cohort 2 - EXPAREL

    A total of 10 subjects will be enrolled. Subjects in this cohort will receive 133mg of EXPAREL admixed with bupivacaine.

    Drug: Exparel Injectable Product · Drug: Bupivacaine

  • Experimental
    Cohort 3 - EXPAREL

    A total of 10 subjects will be enrolled. Subjects in this cohort will receive 266mg of EXPAREL only

    Drug: Exparel Injectable Product

  • Active comparator
    Cohort 4 - bupivacaine

    A total of 10 subjects will be enrolled. Subjects in this cohort will receive 100mg Bupivacaine only.

    Drug: Bupivacaine

Interventions

  • DrugExparel Injectable Product

    bupivacaine liposome injectable suspension

  • DrugBupivacaine

    1.3%, 13.3 mg/mL

05

What researchers measure

Primary outcomes

  1. Pharmacokinetic 1 (Area under the plasma concentration)

    Area under the plasma concentration-versus-time curve (AUC).

    Time frame: predose (up to 15 min before block), 30 min(±5min), 45 min(±5min), and 60 min (±15min) and 30 min(±5min), 45 min(±5min), 1(±15min), 2(±30min), 12(±30min), 24(±1), 60(±2), 72(±2), 84(±2), 96(±3), 120(±3), 144(±3), and 168(±3) hours following block

  2. Pharmacokinetic 2 (Cmax)

    Maximum plasma concentration (Cmax)

    Time frame: predose (up to 15 min before block), 30 min(±5min), 45 min(±5min), and 60 min (±15min) and 30 min(±5min), 45 min(±5min), 1(±15min), 2(±30min), 12(±30min), 24(±1h), 60(±2h), 72(±2h), 84(±2h), 96(±3h), 120(±3h), 144(±3h), and 168(±3h) hours following block

  3. Pharmacokinetic 3 (half-life )

    The apparent terminal elimination half-life (t1/2el).

    Time frame: predose (up to 15 min before block), 30 min(±5min), 45 min(±5min), and 60 min (±15min) and 30 min(±5min), 45 min(±5min), 1(±15min), 2(±30min), 12(±30min), 24(±1h), 60(±2h), 72(±2h), 84(±2h), 96(±3h), 120(±3h), 144(±3h), and 168(±3h) hours following block

  4. Pharmacokinetic 4 (Apparent clearance)

    Apparent clearance (CL/F).

    Time frame: predose (up to 15 min before block), 30 min(±5min), 45 min(±5min), and 60 min (±15min) and 30 min(±5min), 45 min(±5min), 1(±15min), 2(±30min), 12(±30min), 24(±1h), 60(±2h), 72(±2h), 84(±2h), 96(±3h), 120(±3h), 144(±3h), and 168(±3h) hours following block

  5. Pharmacokinetic 5 (volume of distribution)

    Apparent volume of distribution (Vd).

    Time frame: predose (up to 15 min before block), 30 min(±5min), 45 min(±5min), and 60 min (±15min) and 30 min(±5min), 45 min(±5min), 1(±15min), 2(±30min), 12(±30min), 24(±1h), 60(±2h), 72(±2h), 84(±2h), 96(±3h), 120(±3h), 144(±3h), and 168(±3h) hours following block

  6. Pharmacokinetic 6 (Tmax)

    Time of Cmax (Tmax)

    Time frame: predose (up to 15 min before block), 30 min(±5min), 45 min(±5min), and 60 min (±15min) and 30 min(±5min), 45 min(±5min), 1(±15min), 2(±30min), 12(±30min), 24(±1h), 60(±2h), 72(±2h), 84(±2h), 96(±3h), 120(±3h), 144(±3h), and 168(±3h) hours following block

  7. Pharmacodynamic 1 (duration of sensory and motor block)

    Average duration of sensory block and motor block

    Time frame: up to 15 min before block, 15 min(±5 min), 30 min(±5min), 45 min(±5min), and 60 min (±15min) and 30 min(±5min), 45 min(±5min), 1(±15min), 2(±30min), 12(±30min), 24(±1), 60(±2), 72(±2), 84(±2), 96(±3), 120(±3), 144(±3), and 168(±3) hours following block

  8. Pharmacodynamic 2 (duration of sensory and motor block)

    Average duration of sensory block and motor block

    Time frame: up to 15 min before block, 15 min(±5min), 30 min(±5min), 45 min(±5min), and 60 min (±15min) and 30 min(±5min), 45 min(±5min), 1(±15min), 2(±30min), 12(±30min), 24(±1), 60(±2), 72(±2), 84(±2), 96(±3), 120(±3), 144(±3), and 168(±3) hours following block

06

Study locations

1 site
  • First Surgical Hospital
    Bellaire, Texas 77401, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04002089
Lead sponsor
Pacira Pharmaceuticals, Inc
Responsible party
Sponsor
First posted
Jun 28, 2019
Start date
Jul 26, 2019
Primary completion
Dec 2, 2019
Completion
Dec 2, 2019
Last update
Jan 11, 2021

Study contacts

Nayana Nagaraj
study director · Medical Director

Oversight

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

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