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

Phase 3

Completed

• Conditions: Metatarsophalangeal Fushion; Lower Extremity Surgery; Midfoot Fusion; Total Ankle Arthroplasty; Bunion; Hindfoot Fushion
• Interventions: Drug: Exparel; Drug: Bupivacaine Hydrochloride

• Registration Number: NCT04518462
• Lead Sponsor: Pacira Pharmaceuticals, Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-04
• Study First Submitted QC: 2020-08-14
• Study First Posted: 2020-08-19
• Study Start: 2020-10-20
• Primary Completion: 2021-04-05
• Study Completion: 2021-04-05
• Results First Submitted: 2022-03-22
• Status Verified: 2022-07
• Results First Submitted QC: 2022-07-15
• Last Update Submitted: 2022-07-15
• Results First Posted: 2022-07-18
• Last Update Posted: 2022-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EXPAREL arm	Exparel	Subjects randomized to this treatment arm will receive 20 mL (266 mg)EXPAREL mixed with 20 mL saline
EXPAREL admix arm	Bupivacaine Hydrochloride	subjects randomized to this treatment arm will receive 20 mL (266 mg)EXPAREL admixed with 20 mL (50 mg) 0.25% bupivacaine HCl.
EXPAREL admix arm	Exparel	subjects randomized to this treatment arm will receive 20 mL (266 mg)EXPAREL admixed with 20 mL (50 mg) 0.25% bupivacaine HCl.
Bupivacaine HCl Arm	Bupivacaine Hydrochloride	subjects randomized to this treatment arm will receive 40 mL (100 mg)0.25% bupivacaine HCl.

Primary Outcome Measures

Name	Time	Method
Magnitude of the Analgesic Effect (NRS Pain Intensity) (AUC)	Post surgery - 96 hours	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

Secondary Outcome Measures

Name	Time	Method
Total Opioid Consumption	0 hours to 96 hours	Total Opioid Consumption in oral morphine equivalents
Time to First Opioid	Post Surgery through Day 14	Time to First Opioid following a single dose of EXPAREL vs. Bupivacain HCl

Trial Locations

Locations (5)

Lotus Clinical Research; 🇺🇸 Pasadena, California, United States

HD Research, Corp; 🇺🇸 Bellaire, Texas, United States

Arizona Research Center; 🇺🇸 Phoenix, Arizona, United States

Brigham and Women's Hospital; 🇺🇸 Chestnut Hill, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States