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 (STRIDE)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Bunion; Metatarsophalangeal Fusion; Midfoot Fusion; Hindfoot Fusion; Total Ankle Arthroplasty; Forefoot Surgery
• Intervention / Treatment: Drug: EXPAREL 13.3Mg/mL Suspension for Injection; Drug: Bupivacaine Hydrochloride

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 ≥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 (eg, amide-type local anesthetics, opioids, bupivacaine, NSAIDs)
2. 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
3. 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
4. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
5. 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
6. Previous participation in EXPAREL study
7. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance
8. Currently pregnant, nursing, or planning to become pregnant during the study
9. 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
10. Currently on neuroleptic agent [e.g., gabapentin, pregabalin (Lyrica), duloxetine (Cymbalta) etc.]
11. Inadequate sensory function on the foot (monofilament test)

12. 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:

13. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1, Group 1; 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; Combined Sciatic and Adductor Canal Nerve Block with EXPAREL mixed with Bupivacaine (Single Dose)
Active Comparator: Cohort 1, Group 2; 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; Combined Sciatic and Adductor Canal Nerve Block with Bupivacaine HCL
Experimental: Cohort 2, Group 1; 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; Combined Sciatic and Adductor Canal Nerve Block with EXPAREL mixed with Bupivacaine (Single Dose)
Active Comparator: Cohort 2, Group 2; 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; Combined Sciatic and Adductor Canal Nerve Block with Bupivacaine HCL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Postsurgical Opioid Consumption	Total Postsurgical opioid consumption from 0 hours to 96 hours post-surgery	0 hours to 96 hours

Collaborators and Investigators

• Sponsor: Pacira Pharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start (Anticipated): June 15, 2020
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: May 15, 2019
• First Submitted That Met QC Criteria: May 16, 2019
• First Posted (Actual): May 17, 2019

Study Record Updates

• Last Update Posted (Actual): August 13, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired; Bunion; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 402-C-332

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No