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Local Anesthetic

Cohort 1: EXPAREL admix arm for Osteoarthritis

Phase 3
Waitlist Available
Research Sponsored by Pacira Pharmaceuticals, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-24hours, 0-48hours, 0-72hours, 0-96hours
Awards & highlights

Study Summary

The purpose of the study is to compare magnitude of postsurgical analgesic effect in different groups following a single dose of study drug when administered via adductor canal block in subjects undergoing primary unilateral total knee arthroplasty.

Eligible Conditions
  • Osteoarthritis
  • Pain Management

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-24hours, 0-48hours, 0-72hours, 0-96hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-24hours, 0-48hours, 0-72hours, 0-96hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
NRS scores through 96 hours post-surgery
Secondary outcome measures
NRS scores
Postsurgical Opioid Consumption through 96 hours post-surgery
Opioids

Side effects data

From 2017 Phase 3 trial • 232 Patients • NCT02713178
45%
Motor dysfunction
36%
Nausea
31%
Pyrexia
16%
Constipation
11%
Hypotension
9%
Hepatic enzyme increased
7%
Hypokalemia
7%
Muscle twitching
5%
Hiccups
5%
Postprocedural hematoma
5%
Headache
5%
Vomiting
5%
Pruritus
5%
Fall
4%
Dizziness
4%
Dysgeusia
4%
Urinary retention
3%
Dyspepsia
3%
Sensory loss
3%
Joint swelling
1%
Anemia
1%
Insomnia
1%
Confusional state
1%
Postprocedural swelling
1%
Cellulitis
1%
Hemoglobin decreased
1%
Atrial fibrillation
100%
80%
60%
40%
20%
0%
Study treatment Arm
EXPAREL 133 mg
EXPAREL 266 mg
Placebo

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Cohort 2: EXPAREL admix armExperimental Treatment1 Intervention
subjects randomized to this treatment arm will receive 10 mL (133 mg) EXPAREL admixed with 10 mL (50 mg) 0.5% bupivacaine HCl
Group II: Cohort 1: EXPAREL admix armExperimental Treatment1 Intervention
subjects randomized to this treatment arm will receive 10 mL (133 mg) EXPAREL admixed with 10 mL (50 mg) 0.5% bupivacaine HCl
Group III: Cohort 1: Bupivacaine HCl armActive Control1 Intervention
subjects randomized to this treatment arm will receive 10 mL (50 mg) 0.5% bupivacaine HCl mixed with 10 mL normal saline
Group IV: Cohort 2: Bupivacaine HCl armActive Control1 Intervention
subjects randomized to this treatment arm will receive 10 mL (50 mg) 0.5% bupivacaine HCl mixed with 10 mL normal saline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
bupivacaine liposome injectable suspension
2016
Completed Phase 4
~710

Find a Location

Who is running the clinical trial?

Pacira Pharmaceuticals, IncLead Sponsor
135 Previous Clinical Trials
13,836 Total Patients Enrolled
21 Trials studying Osteoarthritis
4,415 Patients Enrolled for Osteoarthritis
Gary NevinsStudy DirectorPacira Pharmaceuticals, Inc
1 Previous Clinical Trials
185 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Phase 3 Adductor Canal Block With EXPAREL in Subjects Undergoing Primary Unilateral Total Knee Arthroplasty
2022. "Phase 3 Adductor Canal Block With EXPAREL in Subjects Undergoing Primary Unilateral Total Knee Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05139030.
~51 spots leftby Apr 2025
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