Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL Admixed With Bupi vs. Bupi Only Administered as Combined Sciatic and Adductor Canal Nerve Block for Postsurgical Analgesia in Lower Extremity Surgeries

NCT03954639 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: 402-C-332
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 81 subjects undergoing lower extremity surgeries with combined sciatic and adductor canal nerve block.

Conditions

Bunion; Metatarsophalangeal Fusion; Midfoot Fusion; Hindfoot Fusion; Total Ankle Arthroplasty; Forefoot Surgery

Outcome Measures

Primary Outcomes (1)

• Magnitude of analgesic effect

  Area under the Curve of the NRS Pain intensity scores from 0 hours to 96 hours post-surgery.

  0 hours to 96 hours

Secondary Outcomes (1)

• Total Postsurgical Opioid Consumption

  0 hours to 96 hours

Study Arms (4)

Cohort 1, Group 1

EXPERIMENTAL

Subjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with EXPAREL. EXPAREL will be mixed with Bupivacaine Subjects enrolled in Cohort 1 will provide blood samples and measures for efficacy and safety.

Drug: EXPAREL 13.3Mg/mL Suspension for Injection

Cohort 1, Group 2

ACTIVE COMPARATOR

Subjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with bupivacaine. Subjects enrolled in Cohort 1 will provide blood samples and measures for efficacy and safety.

Drug: Bupivacaine Hydrochloride

Cohort 2, Group 1

EXPERIMENTAL

Subjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with EXPAREL. EXPAREL will be mixed with Bupivacaine Subjects enrolled in Cohort 2 will provide measures for efficacy and safety.

Drug: EXPAREL 13.3Mg/mL Suspension for Injection

Cohort 2, Group 2

ACTIVE COMPARATOR

Subjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with bupivacaine. Subjects enrolled in Cohort 2 will provide measures for efficacy and safety.

Drug: Bupivacaine Hydrochloride

Interventions

EXPAREL 13.3Mg/mL Suspension for Injection DRUG

Combined Sciatic and Adductor Canal Nerve Block with EXPAREL mixed with Bupivacaine (Single Dose)

Cohort 1, Group 1; Cohort 2, Group 1

Bupivacaine Hydrochloride DRUG

Combined Sciatic and Adductor Canal Nerve Block with Bupivacaine HCL

Cohort 1, Group 2; Cohort 2, Group 2

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 ≥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 (eg, amide-type local anesthetics, opioids, bupivacaine, NSAIDs)
• Documented history of long-term diabetes, renal (serum creatinine level \>2mg/dL \[176.8 μmol/L\]) or hepatic dysfunction (serum alanine or aspartame transferase \> 3 times the upper limit of normal), coagulation or bleeding disorder and severe peripheral vascular disease
• 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 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 any psychiatric or other conditions that would constitute a contraindication to participation in the study
• Currently on neuroleptic agent \[e.g., gabapentin, pregabalin (Lyrica), duloxetine (Cymbalta) etc.\]
• Inadequate sensory function on the foot (monofilament test)
• Chronic opioid use in the last 30 days (≥30 morphine equivalents/ day)
• In addition, the subject may be withdrawn from the study if the subject meets the following criterion during or post-surgery:
• Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that, in the opinion of the investigator, renders the subject medically unstable or complicates the subject's post-operative course

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

MeSH Terms

Conditions

Bunion

Interventions

Suspensions; Injections; Bupivacaine

Condition Hierarchy (Ancestors)

Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 17, 2019
• Study Start: June 15, 2020
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: August 13, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share