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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04518462
Other study ID # 402-C-333
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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)

Study Design


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
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