Phase 3, Sciatic Nerve Block With EXPAREL for Subjects Undergoing Bunionectomy

• Status: Not yet recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is conducted sequentially in two parts.

Part A: The purpose is to obtain information on PK profile, pharmacodynamics (PD), efficacy, safety, and to assess the performance of 266 mg EXPAREL vs 133 mg EXPAREL.

Part B: The purpose is to evaluate the efficacy and safety of the preferred dosage of EXPAREL from Part A compared with bupivacaine HCl.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pacira Pharmaceuticals, Inc
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

1. Male or female, ages 18 or older at screening

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. Primary surgical indication is related to a bunion deformity (i.e., hallux valgus)

5. Indicated to undergo elective (i.e., not emergency) bunionectomy

6. Body Mass Index (BMI) ≥18 and <40 kg/m2

Exclusion Criteria:

1. 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, NSAIDs)

2. 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 foot surgery and which, in the Investigator's opinion, may confound the post dosing assessments

3. Inadequate sensory function of the foot/ankle as assessed by the Investigator

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 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

6. Previous participation in an 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. 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

10. Currently on a neuromodulating agent (e.g., gabapentin, pregabalin [Lyrica], duloxetine [Cymbalta], etc.)

11. Current use of systemic glucocorticoids within 30 days of randomization in this study

12. Use of dexmedetomidine HCl (Precedex®) or clonidine within 3 days of study drug administration

13. Any use of marijuana (including tetrahydrocannabinol (THC) and cannabidiol (CBD)) within 30 days prior to randomization, or planned use during the course of the study

14. Chronic opioid use within 30 days prior to randomization (average ≥30 oral morphine equivalents/day)