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

Bunion Clinical Trial

— STRIDE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04518462
• Other study ID #: 402-C-333
• Status: Completed
• Phase: Phase 3
• Start date: October 20, 2020
• Est. completion date: April 5, 2021

Study information

• Verified date: July 2022
• Source: Pacira Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: April 5, 2021
• Est. primary completion date: April 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Drug:
• Exparel
EXPAREL (bupivacaine liposome injectable suspension)
• Bupivacaine Hydrochloride
0.25% bupivacaine

Locations

Country	Name	City	State
United States	HD Research, Corp	Bellaire	Texas
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Brigham and Women's Hospital	Chestnut Hill	Massachusetts
United States	Lotus Clinical Research	Pasadena	California
United States	Arizona Research Center	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total Opioid Consumption	Total Opioid Consumption in oral morphine equivalents	0 hours to 96 hours
Secondary	Time to First Opioid	Time to First Opioid following a single dose of EXPAREL vs. Bupivacain HCl	Post Surgery through Day 14