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CompletedNCT05157841Updated Jun 26, 2025Results posted

Phase 3, Sciatic Nerve Block With EXPAREL for Subjects Undergoing Bunionectomy

A Phase 3 interventional study of Bupivacaine liposome injectable suspension 266 mg and Bupivacaine HCl in Bunionectomy and Hallux Valgus, sponsored by Pacira Pharmaceuticals, Inc. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-26.

Sponsored by Pacira Pharmaceuticals, Inc · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
185
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The study is conducted sequentially in two parts.

Part A: The purpose is to obtain information on pharmacokinetic (PK) profile, pharmacodynamics (PD), efficacy, safety, and to assess the performance of 266 mg EXPAREL vs 133 mg EXPAREL.

Part B: The purpose is to evaluate the efficacy and safety of the preferred dosage of EXPAREL from Part A compared with bupivacaine HCl.

Read the detailed description

This is a Phase 3, multicenter, randomized, double-blind, active controlled study in approximately 180 subjects undergoing bunionectomy. The study will be conducted in two parts (Part A and Part B). Part A will be completed and analyzed before enrollment in Part B is initiated.

Subjects may be screened up to 45 days prior to the day of surgery but eligibility must be re-confirmed on the day of surgery prior to randomization.

The following screening procedures will be performed after the informed consent form (ICF) is signed (if not standard of care): assess eligibility, record medical/surgical history, record prior and concomitant medications, record demographics and baseline characteristics, record subject height and weight for body mass index (BMI) calculation, assess chronic opioid use in the past 30 days, conduct urine pregnancy test for women of childbearing potential, perform 12-lead EKG, record serious adverse events (SAEs) starting when the ICF is signed, and record medications for treatment of SAEs.

On Day 1, prior to sciatic nerve block, study staff will review Pain Rating Guide with the subject and record their responses to:

  • Numeric rating scale (NRS) score on the worst pain of their operative foot in the last 30 days.
  • NRS score on the average pain of their operative foot in the last 30 days.

Part A will enroll approximately 60 subjects undergoing bunionectomy into 1 of 3 arms. They will be randomized 1:1:1 to either EXPAREL 266 mg, EXPAREL 133 mg, or 0.25% bupivacaine HCl (50mg). Part A subjects will be asked to perform sensory function assessments, perform motor function assessments and obtain PK samples. Based on the findings of the interim analysis after completion of Part A, the study may stop for futility or proceed to Part B. Part B is a 2-arm study with 120 subjects being randomized 1:1 to either the better performing dosage of EXPAREL from Part A (266mg or 133mg) or 0.25% bupivacaine HCl (50mg).

All eligible subjects will receive Celecoxib 200 mg, orally (PO) pre-operatively within four hours prior to surgery.

Part A: On Day 1, Subjects will be randomized (1:1:1) to receive a sciatic (in the popliteal fossa) nerve block with a single dose of either: EXPAREL 266 mg, EXPAREL 133 mg, or 0.25% bupivacaine HCl (50 mg).

Part B: will continue enrolling with one of the EXPAREL arms (EXPAREL 266 mg arm or EXPAREL 133 mg arm) and the bupivacaine HCl arm. Therefore, the EXPAREL study arm that fails to show efficacy (conditional power less than 30% in the Part A analysis) will be dropped and the study will continue with two study arms. The final analysis will include subjects from both Part A and Part B.

  1. If the conditional power of one EXPAREL arm is less than 30% and the other EXPAREL arm is greater than or equal to 30%:

    • The EXPAREL arm with conditional power less than 30% will be dropped in Part B.

  2. If both EXPAREL arms have a conditional power greater than or equal to 30%:

    • If the conditional power of the 266 mg EXPAREL arm is more than 10% greater than the conditional power of the 133 mg EXPAREL arm, then the 266 mg EXPAREL arm will be kept and the 133 mg EXPAREL arm will be dropped. Otherwise, the 133 mg EXPAREL arm will be kept and the 266 mg EXPAREL arm will be dropped in Part B.

  3. If the conditional power of both treatment arms is less than 30%:

    • The study will stop for futility

All subjects will receive a dose of 1000 mg of intravenous (IV) acetaminophen at the time of surgical incision. All subjects will receive one post-operative dose of 1000 mg IV acetaminophen, administered approximately 8 hours after the first dose (approximately 8 hours after incision). The maximum total dose will not exceed 2000 mg. No additional acetaminophen is permitted after the second IV acetaminophen dose.

Medications will be administered on an as needed (PRN) basis; opioids should not be given on a predetermined schedule.

After 96 hours, the analgesic regimen may be adjusted for each subject individually as deemed appropriate by the physician responsible for postsurgical care.

NRS Pain intensity scores (for pain experiencing in operative foot right now, for the worst pain experienced in the operative foot in the last 24 hours, and for the average pain in the operative foot in the last 24 hours) will be asked from the end of surgery to 96 hours post-surgery at designated timepoints.

Subjects in Part A and Part B will be discharged after the completion of the 168h and 96h assessments, respectively.

For the assessment of adverse events (AEs), SAEs, and concomitant medication use, a follow-up phone call will be made on Post Surgery Day (POD) 14 (±3 days).

02

Conditions studied

  • Bunionectomy
  • Hallux Valgus

Keywords

  • EXPAREL
  • Bupivacaine
  • Analgesia
03

In context

Hallux Valgus

144 studies on the registry are indexed under Hallux Valgus; 31 are open to participants now.

This study's enrollment of 185 is above the median of 56 across 106 interventional studies indexed under Hallux Valgus.

Browse Hallux Valgus studies →

Lead sponsor

Pacira Pharmaceuticals, Inc is the lead sponsor of 100 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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female, ages 18 or older at screening
  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. Primary surgical indication is related to a bunion deformity (i.e., hallux valgus) and subject is scheduled to undergo a distal metaphyseal osteotomy procedure (e.g., Austin procedure as opposed to Lapiplasty, Lapidus bunionectomies or base wedge bunionectomies)
  5. Indicated to undergo elective (i.e., not emergency) bunionectomy
  6. Body Mass Index (BMI) ≥18 and \<40 kg/m2

Exclusion criteria

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, NSAIDs)
  2. Concurrent painful physical condition (e.g. arthritis, fibromyalgia, cancer) that may require analgesic treatment with NSAIDs or opioids in the post dosing period for pain that is not strictly related to the foot surgery and which, in the Investigator's opinion, may confound the post dosing assessments
  3. Inadequate sensory function of the foot/ankle as assessed by the Investigator
  4. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
  5. 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
  6. Previous participation in an EXPAREL study
  7. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, could interfere with study assessments or compliance
  8. Currently pregnant, nursing, or planning to become pregnant during the study
  9. 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
  10. Currently on a neuromodulating agent (e.g., gabapentin, pregabalin [Lyrica], duloxetine [Cymbalta], etc.)
  11. Current use of systemic glucocorticoids within 30 days of randomization in this study
  12. Use of dexmedetomidine HCl (Precedex®) or clonidine within 3 days of study drug administration
  13. Any use of marijuana (including tetrahydrocannabinol (THC) and cannabidiol (CBD)) within 30 days prior to randomization, or planned use during the course of the study
  14. Chronic opioid use within 30 days prior to randomization (average ≥30 oral morphine equivalents/day)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
185 participants (actual)

Study arms

  • Experimental
    Part A: EXPAREL 266 mg arm

    subjects randomized to this treatment arm will receive 20 mL (266 mg) EXPAREL mixed with 10 mL saline

    Drug: Bupivacaine liposome injectable suspension 266 mg

  • Experimental
    Part A: EXPAREL 133 mg arm

    subjects randomized to this treatment arm will receive 10 mL (133 mg) EXPAREL mixed with 20 mL saline

    Drug: Bupivacaine liposome injectable suspension 133 mg

  • Active comparator
    Part A: Bupivacaine HCl arm

    Subjects randomized to this treatment arm will receive 20 mL (50 mg) 0.25% bupivacaine HCl mixed with 10 mL saline

    Drug: Bupivacaine HCl

  • Experimental
    Part B: EXPAREL 133 mg arm OR EXPAREL 266 mg arm

    Subjects randomized to this treatment arm will receive 20 mL (266 mg) EXPAREL mixed with 10 mL saline OR 10 mL (133 mg) EXPAREL mixed with 20 mL saline. Dose will be determined following interim analysis of Part A.

    Drug: Bupivacaine liposome injectable suspension 133 mg

  • Active comparator
    Part B: Bupivacaine HCl arm

    subjects randomized to this treatment arm will receive 20 mL (50 mg) 0.25% bupivacaine HCl mixed with 10 mL saline

    Drug: Bupivacaine HCl

Interventions

  • DrugBupivacaine liposome injectable suspension 266 mg

    Sciatic nerve block in the popliteal fossa with EXPAREL 266 mg

    Also known as: EXPAREL

  • DrugBupivacaine HCl

    Sciatic nerve block in the popliteal fossa with Bupivacaine HCl

  • DrugBupivacaine liposome injectable suspension 133 mg

    Sciatic nerve block in the popliteal fossa with EXPAREL 133 mg

    Also known as: EXPAREL

06

What researchers measure

Primary outcomes

  1. NRS Pain Scores Through 96 Hours Post-surgery

    The numeric rating scale pain intensity scores ranging from 0 to 10, where 0 equals no pain and 10 equals the worst possible pain, from 0 to 96 hours post-surgery. For each subject, the area under the curve was derived using the trapezoidal rule on the pain scores adjusted for opioid pain medication using the observed and imputed values. Area under the curve started with the first pain assessment obtained after surgery and use all subsequent pain assessments up to 96 hours post-surgery. Pain scores were taken at 5 interval point 0 hours, 24 hours, 48 hours, 72 hours, and 96 hours. There were also unscheduled pain scores measured before opioid consumption also included in the area under the curve calculation. The area under the curve ranged from 0 to 960. Higher scores represent a worse outcome.

    Time frame: 0- 96 hours post-surgery

Secondary outcomes

  1. Postsurgical Opioid Consumption Through 96 Hours Post-surgery

    Total postsurgical opioid consumption in oral morphine equivalents (OMED) from 0 to 96 hours post-surgery

    Time frame: 0 to 96 hours post-surgery

  2. Opioid-free Subjects Through 96 Hours Post-surgery

    Percentage of opioid-free subjects through 96 hours

    Time frame: 0 to 96 hours post-surgery

  3. First Opioid Consumption Post-surgery

    Time to first opioid consumption post-surgery

    Time frame: 0 to 96 hours post-surgery

  4. NRS Pain Scores Post-surgery

    Worst and average NRS pain intensity scores at 24h, 48h, 72h, and 96h from the end of surgery Worst and average pain intensity scores on a numeric rating scale ranging from 0 to 10, where 0 equals no pain and 10 equals the worst possible pain, from 0 to 24 hours, 24 to 48 hours, 48 to 72 hours, and 72 to 96 hours. Mean scores at each timepoint are provided. The total range is 0 (no pain) to 10 (worst possible pain). Higher values on the scale represent worse outcome.

    Time frame: 0-24 hours, 24-48 hours, 48-72 hours, and 72-96 hours post-surgery

07

Results

Posted Jun 26, 2025

Participant flow

Participants were recruited based on physician referral at 6 sites between February 2022 and April 2022 for Part A and between April 2022 and July 2022 for Part B. The first participant was enrolled on February 15, 2022 and the last participant was enrolled on July 18, 2022.

Part A (14 Days)
Participant flow — Part A (14 Days)
MilestoneEXPAREL 266 mg ArmEXPAREL 133 mg ArmBupivacaine HCl Arm
Started222222
Completed212119
Not completed113
Withdrew: Withdrawal by subject012
Withdrew: Adverse event100
Withdrew: Failure to meet continuation criteria001
Part B (14 Days)
Participant flow — Part B (14 Days)
MilestoneEXPAREL 266 mg ArmEXPAREL 133 mg ArmBupivacaine HCl Arm
Started05960
Completed05960
Not completed000

Outcome measures

PrimaryNRS Pain Scores Through 96 Hours Post-surgery

The numeric rating scale pain intensity scores ranging from 0 to 10, where 0 equals no pain and 10 equals the worst possible pain, from 0 to 96 hours post-surgery. For each subject, the area under the curve was derived using the trapezoidal rule on the pain scores adjusted for opioid pain medication using the observed and imputed values. Area under the curve started with the first pain assessment obtained after surgery and use all subsequent pain assessments up to 96 hours post-surgery. Pain scores were taken at 5 interval point 0 hours, 24 hours, 48 hours, 72 hours, and 96 hours. There were also unscheduled pain scores measured before opioid consumption also included in the area under the curve calculation. The area under the curve ranged from 0 to 960. Higher scores represent a worse outcome.

Time frame:
0- 96 hours post-surgery
Reported as:
Mean · units on a scale*hours
NRS Pain Scores Through 96 Hours Post-surgery
units on a scale*hoursPart A: EXPAREL 266 mg ArmPart A + B: EXPAREL 133 mg ArmPart A + B: Bupivacaine HCl Arm
NRS Pain Scores Through 96 Hours Post-surgery342.3 ± 265.35201.3 ± 180.05377.4 ± 188.60
Statistical analysis
  • Part A + B: EXPAREL 133 mg Arm vs Part A + B: Bupivacaine HCl Arm · ANCOVA · p = <0.00001 · Mean difference (final values): -164.0 · 95% CI -218.3 to -109.6Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age
SecondaryPostsurgical Opioid Consumption Through 96 Hours Post-surgery

Total postsurgical opioid consumption in oral morphine equivalents (OMED) from 0 to 96 hours post-surgery

Time frame:
0 to 96 hours post-surgery
Reported as:
Geometric mean · milligrams oral morphine equivalents
Postsurgical Opioid Consumption Through 96 Hours Post-surgery
milligrams oral morphine equivalentsPart A: EXPAREL 266 mg ArmPart A + B: EXPAREL 133 mg ArmPart A + B: Bupivacaine HCl Arm
Postsurgical Opioid Consumption Through 96 Hours Post-surgery32.68 ± 96.76815.41 ± 126.78141.62 ± 83.925
Statistical analysis
  • Part A + B: EXPAREL 133 mg Arm vs Part A + B: Bupivacaine HCl Arm · ANCOVA · p = <0.00001 · Least square mean difference: 0.39 · 95% CI 0.28 to 0.55
SecondaryOpioid-free Subjects Through 96 Hours Post-surgery

Percentage of opioid-free subjects through 96 hours

Time frame:
0 to 96 hours post-surgery
Reported as:
Number · percentage of participants
Opioid-free Subjects Through 96 Hours Post-surgery
percentage of participantsPart A: EXPAREL 266 mg ArmPart A + B: EXPAREL 133 mg ArmPart A + B: Bupivacaine HCl Arm
Opioid-free Subjects Through 96 Hours Post-surgery4.533.39.8
Statistical analysis
  • Part A + B: EXPAREL 133 mg Arm vs Part A + B: Bupivacaine HCl Arm · ANCOVA · p = 0.0003 · Odds ratio (or): 5.04 · 95% CI 2.01 to 12.62
SecondaryFirst Opioid Consumption Post-surgery

Time to first opioid consumption post-surgery

Time frame:
0 to 96 hours post-surgery
Reported as:
Median · hours
First Opioid Consumption Post-surgery
hoursPart A: EXPAREL 266 mg ArmPart A + B: EXPAREL 133 mg ArmPart A + B: Bupivacaine HCl Arm
First Opioid Consumption Post-surgery16.06 (12.32 to 20.57)20.27 (17.13 to 29.98)20.68 (19.28 to 24.40)
Statistical analysis
  • Part A + B: EXPAREL 133 mg Arm vs Part A + B: Bupivacaine HCl Arm · Cox proportional hazards model · p = 0.0089 · Hazard ratio (hr): 0.65 · 95% CI 0.45 to 0.93Cox proportional hazards model with treatment as main effect and site as categorical and age as continuous covariates.
SecondaryNRS Pain Scores Post-surgery

Worst and average NRS pain intensity scores at 24h, 48h, 72h, and 96h from the end of surgery Worst and average pain intensity scores on a numeric rating scale ranging from 0 to 10, where 0 equals no pain and 10 equals the worst possible pain, from 0 to 24 hours, 24 to 48 hours, 48 to 72 hours, and 72 to 96 hours. Mean scores at each timepoint are provided. The total range is 0 (no pain) to 10 (worst possible pain). Higher values on the scale represent worse outcome.

Time frame:
0-24 hours, 24-48 hours, 48-72 hours, and 72-96 hours post-surgery
Reported as:
Mean · units on a scale
NRS Pain Scores Post-surgery
units on a scalePart A: EXPAREL 266 mg ArmPart A + B: EXPAREL 133 mg ArmPart A + B: Bupivacaine HCl Arm
Worst pain at 24 hours6.0 ± 3.184.4 ± 3.135.3 ± 3.06
Worst pain at 48 hours6.1 ± 2.494.4 ± 3.147.3 ± 2.22
Worst pain at 72 hours4.3 ± 3.552.7 ± 2.876.1 ± 2.69
Worst pain at 96 hours4.4 ± 3.682.8 ± 2.845.1 ± 2.81
Average pain at 24 hours4.7 ± 2.602.8 ± 2.323.0 ± 2.58
Average pain at 48 hours3.9 ± 2.742.9 ± 2.334.8 ± 2.01
Average pain at 72 hours3.5 ± 3.191.8 ± 2.054.1 ± 2.19
Average pain at 96 hours3.2 ± 3.141.7 ± 2.033.3 ± 2.10
Statistical analysis
  • Part A + B: EXPAREL 133 mg Arm vs Part A + B: Bupivacaine HCl Arm · ANCOVA · p = 0.0296 (Worst pain 0-24 hours) · Least square mean difference: -0.8 · 95% CI -1.7 to 0.0Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariate of age.
  • Part A + B: EXPAREL 133 mg Arm vs Part A + B: Bupivacaine HCl Arm · ANCOVA · p = <0.00001 (Worst pain 24-48 hours) · Least square mean difference: -2.9 · 95% CI -3.6 to -2.1Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age
  • Part A + B: EXPAREL 133 mg Arm vs Part A + B: Bupivacaine HCl Arm · ANCOVA · p = <0.00001 (Worst pain 48-72 hours) · Least square mean difference: -3.3 · 95% CI -4.1 to -2.5Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age
  • Part A + B: EXPAREL 133 mg Arm vs Part A + B: Bupivacaine HCl Arm · ANCOVA · p = <0.00001 (Worst pain 72-96 hours) · Least square mean difference: -2.1 · 95% CI -3.0 to -1.3Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age
  • Part A + B: EXPAREL 133 mg Arm vs Part A + B: Bupivacaine HCl Arm · ANCOVA · p = 0.3419 (Average pain 0-24 hours) · Least square mean difference: -0.1 · 95% CI -0.9 to 0.6Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age
  • Part A + B: EXPAREL 133 mg Arm vs Part A + B: Bupivacaine HCl Arm · ANCOVA · p = <0.00001 (Average pain 24-48 hours) · Least square mean difference: -1.9 · 95% CI -2.5 to -1.3Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age
  • Part A + B: EXPAREL 133 mg Arm vs Part A + B: Bupivacaine HCl Arm · ANCOVA · p = <0.00001 (Average pain 48-72 hours) · Least square mean difference: -2.2 · 95% CI -2.8 to -1.6Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age
  • Part A + B: EXPAREL 133 mg Arm vs Part A + B: Bupivacaine HCl Arm · ANCOVA · p = <0.00001 (Average pain 72-96 hours) · Least square mean difference: -1.5 · 95% CI -2.1 to -0.9Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age

Adverse events

Collected over Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14. Non-serious events are listed at a 4% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Part A: EXPAREL 266 mg Arm0/22 (0%)1/22 (4.5%)13/22 (59.1%)
Part A + B: EXPAREL 133 mg Arm0/81 (0%)0/81 (0%)42/81 (51.9%)
Part A + B: Bupivacaine HCl Arm0/82 (0%)1/82 (1.2%)45/82 (54.9%)
Most frequent serious events
Most frequent serious events
EventPart A: EXPAREL 266 mg ArmPart A + B: EXPAREL 133 mg ArmPart A + B: Bupivacaine HCl Arm
PyrexiaGeneral disorders1/220/810/82
HypertensionVascular disorders1/220/810/82
Atrioventricular block second degreeCardiac disorders0/220/811/82
Most frequent other events
Most frequent other events
EventPart A: EXPAREL 266 mg ArmPart A + B: EXPAREL 133 mg ArmPart A + B: Bupivacaine HCl Arm
NauseaGastrointestinal disorders9/2213/8119/82
VomitingGastrointestinal disorders5/224/817/82
ConstipationGastrointestinal disorders3/2210/8116/82
HeadacheNervous system disorders1/228/814/82
PruritusSkin and subcutaneous tissue disorders1/226/815/82
DyspepsiaGastrointestinal disorders1/222/810/82
HypoaesthesiaNervous system disorders1/220/810/82

Baseline characteristics

Number of all participants for whom baseline characteristics were measured

Age, Continuous
Age, Continuous(years)Part A: EXPAREL 266 mg ArmPart A + B: EXPAREL 133 mg ArmPart A + B: Bupivacaine HCl ArmTotal
Mean48.36 ± 10.89650.15 ± 12.82347.24 ± 11.95048.65 ± 12.239
Age, Customized
Age, Customized(Participants)Part A: EXPAREL 266 mg ArmPart A + B: EXPAREL 133 mg ArmPart A + B: Bupivacaine HCl ArmTotal
<45 Years6283064
Between 45 and 65 years164547108
>=65 years08513
Sex: Female, Male
Sex: Female, Male(Participants)Part A: EXPAREL 266 mg ArmPart A + B: EXPAREL 133 mg ArmPart A + B: Bupivacaine HCl ArmTotal
Female217468163
Male171422
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Part A: EXPAREL 266 mg ArmPart A + B: EXPAREL 133 mg ArmPart A + B: Bupivacaine HCl ArmTotal
Hispanic or Latino10263268
Not Hispanic or Latino125550117
Unknown or Not Reported0000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Part A: EXPAREL 266 mg ArmPart A + B: EXPAREL 133 mg ArmPart A + B: Bupivacaine HCl ArmTotal
White164749112
Black/African American4252857
Other29516
Region of Enrollment
Region of Enrollment(participants)Part A: EXPAREL 266 mg ArmPart A + B: EXPAREL 133 mg ArmPart A + B: Bupivacaine HCl ArmTotal
United States228182185
ASA classification
ASA classification(Participants)Part A: EXPAREL 266 mg ArmPart A + B: EXPAREL 133 mg ArmPart A + B: Bupivacaine HCl ArmTotal
ASA 1143954107
ASA 28422878
Body Mass Index
Body Mass Index(Participants)Part A: EXPAREL 266 mg ArmPart A + B: EXPAREL 133 mg ArmPart A + B: Bupivacaine HCl ArmTotal
<25 kg/m^28212453
25 to <30 kg/m^210273269
≥30 kg/m^24332663

2 further baseline measures are reported on the registry.

08

Study locations

7 sites
  • Arkansas Surgical Hospital
    North Little Rock, Arkansas 72118, United States
  • Lotus Clinical Research
    Pasadena, California 91105, United States
  • Midwest Clinical Research Center
    Dayton, Ohio 45417, United States
  • HD Research- First Surgical Hospital
    Bellaire, Texas 77401, United States
  • HD Research-Legent Orthopedic Hospital
    Carrollton, Texas 75006, United States
  • Houston Heights Hospital
    Houston, Texas 77008, United States
  • Endeavor Clinical Trials
    San Antonio, Texas 78240, United States
09

References and documents

Publications

  • Schwartz G, Gadsden JC, Gonzales J, Hutchins J, Song J, Brady O, DiGiorgi M, Winston R. A phase 3 active-controlled trial of liposomal bupivacaine via sciatic nerve block in the popliteal fossa after bunionectomy. J Clin Anesth. 2024 Jun;94:111402. doi: 10.1016/j.jclinane.2024.111402. Epub 2024 Feb 9. PubMed 38340677 ↗

Study documents

  • Study protocol · Feb 24, 2022
  • Statistical analysis plan · Dec 8, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05157841
Lead sponsor
Pacira Pharmaceuticals, Inc
Responsible party
Sponsor
First posted
Dec 15, 2021
Start date
Feb 15, 2022
Primary completion
Aug 17, 2022
Completion
Aug 17, 2022
Results posted
Jun 26, 2025
Last update
Jun 26, 2025

Study contacts

Gary Nevins
study director · Pacira Pharmaceuticals, Inc

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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