Bunion Clinical Trial
— STRIDEOfficial 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
Verified date | July 2022 |
Source | Pacira Pharmaceuticals, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 120 subjects undergoing lower extremity surgeries.
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) |
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 |
Lead Sponsor | Collaborator |
---|---|
Pacira Pharmaceuticals, Inc |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01435577 -
Intravenous Tapentadol in Post-Bunionectomy Pain
|
Phase 2 | |
Terminated |
NCT05082012 -
Early Weight-Bearing After the Lapiplasty Mini-Incision Procedure (Mini3D)
|
N/A | |
Terminated |
NCT03257540 -
Early Weight-Bearing After Lapidus Arthrodesis
|
||
Completed |
NCT04084262 -
Multi-Plane Hallux Valgus Correction With the Phantom® Nail
|
||
Active, not recruiting |
NCT03740282 -
Early Weight-Bearing After the Lapiplasty Procedure
|
N/A | |
Completed |
NCT01743625 -
Safety and Efficacy Study of COV155 for Post-operative Bunionectomy Pain
|
Phase 3 | |
Completed |
NCT01484652 -
Safety and Efficacy of COV795 in Moderate to Severe Post-Operative Bunionectomy Pain With an Open-label Extension
|
Phase 3 | |
Recruiting |
NCT05831449 -
CPL-01 in the Management of Postoperative Pain After Bunionectomy
|
Phase 3 | |
Terminated |
NCT01133639 -
Ketorolac Effects on Post-operative Pain and Bone Healing
|
N/A | |
Completed |
NCT04826328 -
Study to Evaluate the Safety and Tolerability of FX301 in Patients Undergoing Bunionectomy
|
Phase 1 | |
Recruiting |
NCT05773846 -
A Study to Evaluate Analgesic Efficacy and Safety of PRF-110 for Post-surgical Pain
|
Phase 3 | |
Completed |
NCT03653429 -
Efficacy of Tranexamic Acid in Foot and Ankle Surgeries
|
Phase 4 | |
Recruiting |
NCT04751344 -
Liposomal Bupivacaine Versus Bupivacaine Plain for Operative Pain Management of Forefoot Surgery
|
Phase 4 | |
Withdrawn |
NCT03954639 -
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
|
Phase 3 | |
Completed |
NCT04002089 -
Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety, of EXPAREL Administered as Sciatic Nerve Block (In Popliteal Fossa), for Postsurgical Analgesia in Subjects Undergoing Bunionectomy
|
Phase 1 | |
Terminated |
NCT02499575 -
Pericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures
|
N/A | |
Completed |
NCT00613938 -
A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy.
|
Phase 3 | |
Completed |
NCT03246971 -
Study of Wafermineâ„¢ for Post-bunionectomy or Abdominoplasty Pain
|
Phase 2 | |
Completed |
NCT00890682 -
Study of Postoperative Analgesia in Bunionectomy
|
Phase 3 | |
Active, not recruiting |
NCT05602844 -
Clinical Trial on Patient-Specific-Instrumentation Assisted Lapidus Fusion for Hallux Valgus
|
N/A |