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Completed

NCT Number: NCT04002089

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

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.

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Key information

Conditions

Bunion Foot Deformities Foot Deformities, Acquired Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

First Surgical Hospital

Bellaire, Texas, 77401, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)
  • Documented history of long-term diabetes or severe peripheral vascular disease
  • 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).
  • 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
  • History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
  • 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
  • Previous participation in an EXPAREL study
  • 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 any psychiatric or other conditions that would constitute a contraindication to participation in the study
  • Currently on neuroleptic agent [e.g., gabapentin, pregabalin (Lyrica), duloxetine (Cymbalta) etc.]
  • Inadequate sensory function on the foot (monofilament test)
  • 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:

  • 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

Treatment and study plan

Exparel Injectable Product

Drug

bupivacaine liposome injectable suspension

Bupivacaine

Drug

1.3%, 13.3 mg/mL

Primary outcomes

  1. Pharmacokinetic 1 (Area under the plasma concentration)

    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

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

  2. Pharmacokinetic 2 (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

    Maximum plasma concentration (Cmax)

  3. Pharmacokinetic 3 (half-life )

    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

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

  4. Pharmacokinetic 4 (Apparent clearance)

    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

    Apparent clearance (CL/F).

  5. Pharmacokinetic 5 (volume of distribution)

    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

    Apparent volume of distribution (Vd).

  6. Pharmacokinetic 6 (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

    Time of Cmax (Tmax)

  7. Pharmacodynamic 1 (duration of sensory 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

    Average duration of sensory block and motor block

  8. Pharmacodynamic 2 (duration of sensory 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

    Average duration of sensory block and motor block

Sponsors and collaborators

Lead sponsor

Pacira Pharmaceuticals, Inc

Industry

Registry information

Official study title

A Phase 1, Pilot, Open Label, Dose Escalation 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 28, 2019
Registry last updated
Jan 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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