Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL, EXPAREL Admixed With Bupivacaine HCl vs. Bupivacaine HCl Administered as Combined Sciatic and Saphenous Nerve Blocks for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries (STRIDE)

Pacira

Status and phase: Completed; Phase 3

Conditions: Hindfoot Fushion; Bunion; Midfoot Fusion; Lower Extremity Surgery; Metatarsophalangeal Fushion; Total Ankle Arthroplasty

Treatments: Drug: Exparel; Drug: Bupivacaine Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT04518462

402-C-333

Details and patient eligibility

About

This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 120 subjects undergoing lower extremity surgeries.

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 (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, nonsteroidal anti-inflammatory drugs [NSAIDs])
2. 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
3. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
4. 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
5. Previous participation in an EXPAREL study
6. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance
7. Currently pregnant, nursing, or planning to become pregnant during the study
8. 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.
9. Currently on a neuromodulating agent neuroleptic agent (e.g., gabapentin, pregabalin [Lyrica], duloxetine [Cymbalta], etc.)
10. Inadequate sensory function on the foot (monofilament test)
11. Chronic opioid use within 30 days prior to randomization (average ≥30 oral morphine equivalents/day)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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121 participants in 3 patient groups

EXPAREL arm

Experimental group

Description:

Subjects randomized to this treatment arm will receive 20 mL (266 mg)EXPAREL mixed with 20 mL saline

Treatment:

Drug: Exparel

EXPAREL admix arm

Experimental group

Description:

subjects randomized to this treatment arm will receive 20 mL (266 mg)EXPAREL admixed with 20 mL (50 mg) 0.25% bupivacaine HCl.

Treatment:

Drug: Bupivacaine Hydrochloride

Drug: Exparel

Bupivacaine HCl Arm

Active Comparator group

Description:

subjects randomized to this treatment arm will receive 40 mL (100 mg)0.25% bupivacaine HCl.

Treatment:

Drug: Bupivacaine Hydrochloride