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

NCT04518462 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 402-C-333
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Magnitude of the Analgesic Effect (NRS Pain Intensity) (AUC)

  To compare the magnitude of the analgesic effect (NRS pain intensity scores) following a single dose injection of EXPAREL vs. bupivacaine hydrochloride (HCl) when administered as combined sciatic (in the popliteal fossa) and saphenous (in the adductor canal) nerve blocks in subjects undergoing lower extremity surgeries. Numerical Rating Scale: an 11 point scale 0=no pain, 10= the worst pain imaginable. The area under the curve (AUC) of the NRS pain intensity scores from 0 to 96 hours post-surgery comparing EXPAREL to 0.25% bupivacaine HCl

  Post surgery - 96 hours

Secondary Outcomes (2)

• Total Opioid Consumption

  0 hours to 96 hours

• Time to First Opioid

  Post Surgery through Day 14

Study Arms (3)

EXPAREL arm

EXPERIMENTAL

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

Drug: Exparel

EXPAREL admix arm

EXPERIMENTAL

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

Drug: Exparel; Drug: Bupivacaine Hydrochloride

Bupivacaine HCl Arm

ACTIVE COMPARATOR

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

Drug: Bupivacaine Hydrochloride

Interventions

Exparel DRUG

EXPAREL (bupivacaine liposome injectable suspension)

EXPAREL admix arm; EXPAREL arm

Bupivacaine Hydrochloride DRUG

0.25% bupivacaine

Bupivacaine HCl Arm; EXPAREL admix arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (BMI) ≥18 and ≤40 kg/m2

You may not qualify if:

• 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 \[NSAIDs\])
• 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 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.
• Currently on a neuromodulating agent neuroleptic agent (e.g., gabapentin, pregabalin \[Lyrica\], duloxetine \[Cymbalta\], etc.)
• Inadequate sensory function on the foot (monofilament test)
• Chronic opioid use within 30 days prior to randomization (average ≥30 oral morphine equivalents/day)

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (5)

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Lotus Clinical Research

Pasadena, California, 91105, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 02467, United States

Location

HD Research, Corp

Bellaire, Texas, 77401, United States

Location

MeSH Terms

Conditions

Bunion

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Pacira Medical Information
• Organization: Pacira Pharmaceuticals, Inc.

MedInfo@Pacira.com

1-855-793-9729

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 19, 2020
• Study Start: October 20, 2020
• Primary Completion: April 5, 2021
• Study Completion: April 5, 2021
• Last Updated: July 18, 2022
• Results First Posted: July 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)