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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-20

Study Completion Date

2021-04-05

Brief Summary

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

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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EXPAREL arm

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

Group Type EXPERIMENTAL

Exparel

Intervention Type DRUG

EXPAREL (bupivacaine liposome injectable suspension)

EXPAREL admix arm

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

Group Type EXPERIMENTAL

Exparel

Intervention Type DRUG

EXPAREL (bupivacaine liposome injectable suspension)

Bupivacaine Hydrochloride

Intervention Type DRUG

0.25% bupivacaine

Bupivacaine HCl Arm

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

Group Type ACTIVE_COMPARATOR

Bupivacaine Hydrochloride

Intervention Type DRUG

0.25% bupivacaine

Interventions

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Exparel

EXPAREL (bupivacaine liposome injectable suspension)

Intervention Type DRUG

Bupivacaine Hydrochloride

0.25% bupivacaine

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No