A Phase 3 interventional study of Exparel and Bupivacaine Hydrochloride in Lower Extremity Surgery, Bunion and Metatarsophalangeal Fushion, sponsored by Pacira Pharmaceuticals, Inc. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-18.
Sponsored by Pacira Pharmaceuticals, Inc · Phase 3, Interventional, and Treatment
This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 120 subjects undergoing lower extremity surgeries.
58 studies on the registry are indexed under Bunion; 5 are open to participants now.
This study's enrollment of 121 is above the median of 100 across 47 interventional studies indexed under Bunion.
Browse Bunion studies →Pacira Pharmaceuticals, Inc is the lead sponsor of 102 studies on the registry; 3 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 17 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects randomized to this treatment arm will receive 20 mL (266 mg)EXPAREL mixed with 20 mL saline
Drug: Exparel
subjects randomized to this treatment arm will receive 20 mL (266 mg)EXPAREL admixed with 20 mL (50 mg) 0.25% bupivacaine HCl.
Drug: Exparel · Drug: Bupivacaine Hydrochloride
subjects randomized to this treatment arm will receive 40 mL (100 mg)0.25% bupivacaine HCl.
Drug: Bupivacaine Hydrochloride
EXPAREL (bupivacaine liposome injectable suspension)
0.25% bupivacaine
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
Time frame: Post surgery - 96 hours
Total Opioid Consumption
Total Opioid Consumption in oral morphine equivalents
Time frame: 0 hours to 96 hours
Time to First Opioid
Time to First Opioid following a single dose of EXPAREL vs. Bupivacain HCl
Time frame: Post Surgery through Day 14
| Milestone | EXPAREL Arm | EXPAREL Admix Arm | Bupivacaine HCl Arm |
|---|---|---|---|
| Started | 40 | 41 | 40 |
| Completed | 39 | 40 | 39 |
| Not completed | 1 | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 |
| Withdrew: Physician decision | 1 | 1 | 0 |
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
| score on a scale*hours | EXPAREL Arm | EXPAREL Admix Arm | Bupivacaine HCl Arm |
|---|---|---|---|
| Magnitude of the Analgesic Effect (NRS Pain Intensity) (AUC) | 298.65 ± 173.524 | 358.10 ± 223.610 | 380.05 ± 220.878 |
Total Opioid Consumption in oral morphine equivalents
| OMED mg | EXPAREL Arm | EXPAREL Admix Arm | Bupivacaine HCl Arm |
|---|---|---|---|
| Total Opioid Consumption | 20.68 (13.51 to 31.65) | 23.56 (15.54 to 35.73) | 19.84 (12.72 to 30.96) |
Time to First Opioid following a single dose of EXPAREL vs. Bupivacain HCl
| hours | EXPAREL Arm | EXPAREL Admix Arm | Bupivacaine HCl Arm |
|---|---|---|---|
| Time to First Opioid | 5.65 (0.72 to 13.55) | 11.93 (5.15 to 16.28) | 16.67 (7.53 to 22.33) |
Collected over Adverse events (AEs) and SAEs were recorded from the time of informed consent through POD 14.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| EXPAREL Arm | 0/39 (0%) | 0/39 (0%) | 28/39 (71.8%) |
| EXPAREL Admix Arm | 0/41 (0%) | 0/41 (0%) | 29/41 (70.7%) |
| Bupivacaine HCl Arm | 0/39 (0%) | 0/39 (0%) | 31/39 (79.5%) |
| Event | EXPAREL Arm | EXPAREL Admix Arm | Bupivacaine HCl Arm |
|---|---|---|---|
| NauseaGastrointestinal disorders | 8/39 | 12/41 | 7/39 |
| ConstipationGastrointestinal disorders | 9/39 | 11/41 | 11/39 |
| ParaesthesiaNervous system disorders | 5/39 | 3/41 | 11/39 |
| HeadacheNervous system disorders | 10/39 | 4/41 | 7/39 |
| HypoaesthesiaNervous system disorders | 8/39 | 9/41 | 0/39 |
| VomitingGastrointestinal disorders | 1/39 | 6/41 | 2/39 |
| DizzinessNervous system disorders | 3/39 | 2/41 | 2/39 |
| PruritisSkin and subcutaneous tissue disorders | 3/39 | 1/41 | 1/39 |
| PyrexiaGeneral disorders | 2/39 | 0/41 | 1/39 |
| Blood Pressure IncreasedInvestigations | 2/39 | 2/41 | 1/39 |
| Age, Customized(Participants) | EXPAREL Arm | EXPAREL Admix Arm | Bupivacaine HCl Arm | Total |
|---|---|---|---|---|
| <45 years | 11 | 14 | 18 | 43 |
| >/=45 years | 28 | 26 | 22 | 76 |
| Sex: Female, Male(Participants) | EXPAREL Arm | EXPAREL Admix Arm | Bupivacaine HCl Arm | Total |
|---|---|---|---|---|
| Female | 35 | 36 | 27 | 98 |
| Male | 4 | 4 | 13 | 21 |
| Ethnicity (NIH/OMB)(Participants) | EXPAREL Arm | EXPAREL Admix Arm | Bupivacaine HCl Arm | Total |
|---|---|---|---|---|
| Hispanic or Latino | 10 | 12 | 15 | 37 |
| Not Hispanic or Latino | 28 | 26 | 25 | 79 |
| Unknown or Not Reported | 1 | 2 | 0 | 3 |
| Race (NIH/OMB)(Participants) | EXPAREL Arm | EXPAREL Admix Arm | Bupivacaine HCl Arm | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 0 | 1 |
| Asian | 1 | 0 | 3 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 5 | 11 | 7 | 23 |
| White | 32 | 26 | 30 | 88 |
| More than one race | 0 | 1 | 0 | 1 |
| Unknown or Not Reported | 1 | 1 | 0 | 2 |
| American Society of Anesthesiologists (ASA) Classification(Participants) | EXPAREL Arm | EXPAREL Admix Arm | Bupivacaine HCl Arm | Total |
|---|---|---|---|---|
| ASA 1 | 15 | 12 | 23 | 50 |
| ASA 2 | 24 | 26 | 17 | 67 |
| ASA 3 | 0 | 2 | 0 | 2 |
| ASA >/= 4 | 0 | 0 | 0 | 0 |
| Height(participants) | EXPAREL Arm | EXPAREL Admix Arm | Bupivacaine HCl Arm | Total |
|---|---|---|---|---|
| <165 cm | 20 | 21 | 20 | 61 |
| >/= 165 cm | 19 | 19 | 20 | 58 |
| Weight(kg) | EXPAREL Arm | EXPAREL Admix Arm | Bupivacaine HCl Arm | Total |
|---|---|---|---|---|
| Mean | 77.05 (43.5 to 120.2) | 83.03 (49.8 to 117.3) | 77.34 (52.9 to 136.6) | 79.16 (43.5 to 136.6) |
| Body Mass Index (BMI) kg/m2(participants) | EXPAREL Arm | EXPAREL Admix Arm | Bupivacaine HCl Arm | Total |
|---|---|---|---|---|
| <25 kg/m2 | 10 | 9 | 10 | 29 |
| 25- <30kg/m2 | 15 | 10 | 19 | 44 |
| >/= 30 kg/m2 | 14 | 21 | 11 | 46 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2020 to primary completion in Apr 2021, 5 months.
Results were first posted in Jul 2022, 1 year 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Liposomal Bupivacaine · Bupivacaine