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 (STRIDE)
Primary Purpose
Lower Extremity Surgery, Bunion, Metatarsophalangeal Fushion
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Exparel
Bupivacaine Hydrochloride
Sponsored by

About this trial
This is an interventional treatment trial for Lower Extremity Surgery
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
- Arizona Research Center
- Lotus Clinical Research
- Massachusetts General Hospital
- Brigham and Women's Hospital
- HD Research, Corp
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
EXPAREL arm
EXPAREL admix arm
Bupivacaine HCl Arm
Arm Description
Subjects randomized to this treatment arm will receive 20 mL (266 mg)EXPAREL mixed with 20 mL saline
subjects randomized to this treatment arm will receive 20 mL (266 mg)EXPAREL admixed with 20 mL (50 mg) 0.25% bupivacaine HCl.
subjects randomized to this treatment arm will receive 40 mL (100 mg)0.25% bupivacaine HCl.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Total Opioid Consumption
Total Opioid Consumption in oral morphine equivalents
Time to First Opioid
Time to First Opioid following a single dose of EXPAREL vs. Bupivacain HCl
Full Information
NCT ID
NCT04518462
First Posted
August 4, 2020
Last Updated
July 15, 2022
Sponsor
Pacira Pharmaceuticals, Inc
1. Study Identification
Unique Protocol Identification Number
NCT04518462
Brief Title
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
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
April 5, 2021 (Actual)
Study Completion Date
April 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pacira Pharmaceuticals, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 120 subjects undergoing lower extremity surgeries.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Extremity Surgery, Bunion, Metatarsophalangeal Fushion, Midfoot Fusion, Hindfoot Fushion, Total Ankle Arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EXPAREL arm
Arm Type
Experimental
Arm Description
Subjects randomized to this treatment arm will receive 20 mL (266 mg)EXPAREL mixed with 20 mL saline
Arm Title
EXPAREL admix arm
Arm Type
Experimental
Arm Description
subjects randomized to this treatment arm will receive 20 mL (266 mg)EXPAREL admixed with 20 mL (50 mg) 0.25% bupivacaine HCl.
Arm Title
Bupivacaine HCl Arm
Arm Type
Active Comparator
Arm Description
subjects randomized to this treatment arm will receive 40 mL (100 mg)0.25% bupivacaine HCl.
Intervention Type
Drug
Intervention Name(s)
Exparel
Intervention Description
EXPAREL (bupivacaine liposome injectable suspension)
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride
Intervention Description
0.25% bupivacaine
Primary Outcome Measure Information:
Title
Magnitude of the Analgesic Effect (NRS Pain Intensity) (AUC)
Description
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
Time Frame
Post surgery - 96 hours
Secondary Outcome Measure Information:
Title
Total Opioid Consumption
Description
Total Opioid Consumption in oral morphine equivalents
Time Frame
0 hours to 96 hours
Title
Time to First Opioid
Description
Time to First Opioid following a single dose of EXPAREL vs. Bupivacain HCl
Time Frame
Post Surgery through Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Facility Information:
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
Lotus Clinical Research
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States
Facility Name
HD Research, Corp
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
We'll reach out to this number within 24 hrs