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This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 120 subjects undergoing lower extremity surgeries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EXPAREL arm | Experimental | Subjects randomized to this treatment arm will receive 20 mL (266 mg)EXPAREL mixed with 20 mL saline |
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| EXPAREL admix arm | Experimental | subjects randomized to this treatment arm will receive 20 mL (266 mg)EXPAREL admixed with 20 mL (50 mg) 0.25% bupivacaine HCl. |
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| Bupivacaine HCl Arm | Active Comparator | subjects randomized to this treatment arm will receive 40 mL (100 mg)0.25% bupivacaine HCl. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exparel | Drug | EXPAREL (bupivacaine liposome injectable suspension) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Consumption | Total Opioid Consumption in oral morphine equivalents | 0 hours to 96 hours |
| Time to First Opioid | Time to First Opioid following a single dose of EXPAREL vs. Bupivacain HCl |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Research Center | Phoenix | Arizona | 85053 | United States | ||
| Lotus Clinical Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | EXPAREL Arm | Subjects randomized to this treatment arm will receive 20 mL (266 mg) EXPAREL mixed with 20 mL saline EXPAREL (bupivacaine liposome injectable suspension) |
| FG001 | EXPAREL Admix Arm |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 6, 2020 | Mar 7, 2022 |
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| Bupivacaine Hydrochloride | Drug | 0.25% bupivacaine |
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| Post Surgery through Day 14 |
| Pasadena |
| California |
| 91105 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Chestnut Hill | Massachusetts | 02467 | United States |
| HD Research, Corp | Bellaire | Texas | 77401 | United States |
subjects randomized to this treatment arm will receive 20 mL (266 mg) EXPAREL admixed with 20 mL (50 mg) 0.25% bupivacaine HCl.
EXPAREL (bupivacaine liposome injectable suspension)
Bupivacaine Hydrochloride: 0.25% bupivacaine
| FG002 | Bupivacaine HCl Arm | subjects randomized to this treatment arm will receive 40 mL (100 mg) 0.25% bupivacaine HCl. Bupivacaine Hydrochloride: 0.25% bupivacaine |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | EXPAREL Arm | Subjects randomized to this treatment arm will receive 20 mL (266 mg) EXPAREL mixed with 20 mL saline EXPAREL (bupivacaine liposome injectable suspension) |
| BG001 | EXPAREL Admix Arm | subjects randomized to this treatment arm will receive 20 mL (266 mg) EXPAREL admixed with 20 mL (50 mg) 0.25% bupivacaine HCl. EXPAREL (bupivacaine liposome injectable suspension) Bupivacaine Hydrochloride: 0.25% bupivacaine |
| BG002 | Bupivacaine HCl Arm | subjects randomized to this treatment arm will receive 40 mL (100 mg) 0.25% bupivacaine HCl. Bupivacaine Hydrochloride: 0.25% bupivacaine |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| American Society of Anesthesiologists (ASA) Classification | ASA I normal, healthy pt. ASA II mild systemic disease ASA III severe systemic disease ASA IV severe systemic disease that is a constant threat to life | Count of Participants | Participants |
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| Height | Number | participants |
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| Weight | Mean | Full Range | kg |
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| Body Mass Index (BMI) kg/m2 | Number | participants |
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| Average and worst pain intensity score (NRS) in the last 30 days | Numerical Rating Scale: an 11 point scale 0=no pain, 10= the worst pain imaginable | Mean | Standard Deviation | score on a scale |
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| Pain Catastrophizing Scale Total Score | Each question on the Pain Catastrophizing Scale (PCS) is rated from 0 (not at all) to 4 (all the time) total score is from 0-52, with subscale scores assessing rumination, magnification and helplessness. | Mean | Standard Deviation | score on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | score on a scale*hours | Post surgery - 96 hours |
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| Secondary | Total Opioid Consumption | Total Opioid Consumption in oral morphine equivalents | Posted | Least Squares Mean | 95% Confidence Interval | OMED mg | 0 hours to 96 hours |
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| Secondary | Time to First Opioid | Time to First Opioid following a single dose of EXPAREL vs. Bupivacain HCl | Posted | Mean | 95% Confidence Interval | hours | Post Surgery through Day 14 |
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Adverse events (AEs) and SAEs were recorded from the time of informed consent through POD 14.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EXPAREL Arm | Subjects randomized to this treatment arm will receive 20 mL (266 mg) EXPAREL mixed with 20 mL saline EXPAREL (bupivacaine liposome injectable suspension) | 0 | 39 | 0 | 39 | 28 | 39 |
| EG001 | EXPAREL Admix Arm | subjects randomized to this treatment arm will receive 20 mL (266 mg) EXPAREL admixed with 20 mL (50 mg) 0.25% bupivacaine HCl. EXPAREL (bupivacaine liposome injectable suspension) Bupivacaine Hydrochloride: 0.25% bupivacaine | 0 | 41 | 0 | 41 | 29 | 41 |
| EG002 | Bupivacaine HCl Arm | subjects randomized to this treatment arm will receive 40 mL (100 mg) 0.25% bupivacaine HCl. Bupivacaine Hydrochloride: 0.25% bupivacaine | 0 | 39 | 0 | 39 | 31 | 39 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Blood Pressure Increased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Motor dysfuction | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Pruritis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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Results conducted at Site shall not be published before 1st multicenter publication by Sponsor but can proceed if there is no such publication \
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pacira Medical Information | Pacira Pharmaceuticals, Inc. | 1-855-793-9729 | MedInfo@Pacira.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 27, 2021 | Mar 22, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000071378 | Bunion |
| ID | Term |
|---|---|
| D005531 | Foot Deformities, Acquired |
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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| >/=45 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| ASA 2 |
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| ASA 3 |
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| ASA >/= 4 |
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| >/= 165 cm |
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| 25- <30kg/m2 |
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| >/= 30 kg/m2 |
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| worst NRS |
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