Clinical Trials

Study Title |

A Phase-3, Randomized, Double-Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety & Pharmacokinetics of EXPAREL vs Bupivacaine Administered as Combined Sciatic and Femoral Triangle Nerve Block, For Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries

Primary Objective |

To characterize and compare the magnitude of analgesic effect following a single dose injection of EXPAREL® (bupivacaine liposome injectable suspension) vs bupivacaine HCl when administered as combined sciatic (in popliteal fossa) and femoral triangle nerve block in subjects undergoing lower extremity surgeries

Secondary Objectives |

To assess the efficacy, safety, and pharmacokinetic (PK) profile of EXPAREL when administered as combined sciatic (in popliteal fossa) and femoral triangle nerve block in subjects undergoing lower extremity surgeries

Study Summary

Study Status: Recruiting

NCT Number: NCT03954639

Study Nickname: STRIDE

Enrollment goal

goal

81

Intervention(s)

intervention

EXPAREL,
Bupivacaine HCl

Phase

phase

3

Condition

condition

Lower Extremity
Surgeries

Target Number of Sites: 10

Key Participation Criteria

Gender

both

Both

Age

18years
and older

Time Commitment

time

Maximum of 47 days

Procedures included

procedure

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

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 ≥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 (eg, amide-type local anesthetics, opioids, bupivacaine, NSAIDs)
  • Documented history of long-term diabetes, renal (serum creatinine level >2 mg/dL [176.8 μmol/L]) or hepatic dysfunction (serum alanine or aspartame transferase >3 times the upper limit of normal), coagulation or bleeding disorder, or 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® (bupivacaine liposome injectable suspension) 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 (eg, 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 (eg, excessive bleeding, acute sepsis) that, in the opinion of the investigator, renders the subject medically unstable or complicates the subject’s postsurgical course

Where to participate

Coordinates

HD Research Corp

5108 Valerie St Bellaire, TX 77401

Duke University

2301 Erwin Rd, Durham, NC 27710

Massachusetts General Hospital

55 Fruit St, Boston, MA 02114

University of Minnesota

Division of Anesthesiology, B515 Mayo Memorial Building (MMC 294), 420 Delaware St. SE, Minneapolis, MN 55455

Brigham and Women's Hospital

75 Francis Street, Boston, MA 02114

West Virginia University

One Medical Center Drive, PO Box 8255, Morgantown, WV 26506

Cleveland Clinic Foundation

9500 Euclid Avenue, Cleveland, OH 44195

The University of Texas Medical Branch at Galveston

301 University Blvd, Galveston, TX 77555

Northern California research Trials, Inc.

39810 Sharon Avenue, Davis, CA 95616

Closest Location to Participate

HD Research Corp
5108 Valerie St Bellaire, TX 77401

Not Yet Recruiting

Duke University
2301 Erwin Rd, Durham, NC 27710

Not Yet Recruiting

Massachusetts General Hospital
55 Fruit St, Boston, MA 02114

Not Yet Recruiting

University of Minnesota
Division of Anesthesiology, B515 Mayo Memorial Building (MMC 294), 420 Delaware St. SE, Minneapolis, MN 55455

Not Yet Recruiting

Brigham and Women's Hospital
75 Francis Street, Boston, MA 02114

Not Yet Recruiting

West Virginia University
One Medical Center Drive, PO Box 8255, Morgantown, WV 26506

Not Yet Recruiting

Cleveland Clinic Foundation
9500 Euclid Avenue, Cleveland, OH 44195

Not Yet Recruiting

The University of Texas Medical Branch at Galveston
301 University Blvd, Galveston, TX 77555

Not Yet Recruiting

Northern California research Trials, Inc.
39810 Sharon Avenue, Davis, CA 95616

Recruiting

If you have any questions for clinical trials, please contact clinicaltrials@pacira.com.