← Back to Search

Local Anesthetic

Liposomal Bupivacaine for Healthy Volunteers

Phase 1
Recruiting
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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7-8 weeks

Summary

This trial tests a new slow-release pain-relief drug called Liposomal Bupivacaine 13.3 in healthy adults to ensure it is safe and well-tolerated. Liposomal bupivacaine is designed to provide extended postsurgical pain relief and reduce opioid consumption.

Who is the study for?
Healthy adults aged 18-50, with no history of severe headaches, back conditions, or chronic pain. Participants must not have allergies to study medications like bupivacaine and should not be on certain medications like corticosteroids before the trial. Women must not be pregnant or nursing.
What is being tested?
The safety and effects of Liposomal Bupivacaine 13.3 are being tested when given as a single spinal injection to healthy volunteers. The trial will also measure how the drug moves through and affects the body.
What are the potential side effects?
Possible side effects may include reactions at the injection site, headache, nausea, dizziness, back pain, numbness or weakness in legs if it affects nerves in the spine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7-8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7-8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Apparent clearance (CL/F)
Apparent volume of distribution (Vd)
Area under the plasma concentration-versus-time curve (AUC0-last and AUC0- ∞)
+3 more
Secondary study objectives
Average duration of sensory block and motor block
Average time to onset of sensory block and motor block
Other study objectives
Incidence of treatment-emergent AEs (TEAEs) through Day 9
Proportion of subjects who have any of the neurological events.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Liposomal Bupivacaine 13.3Experimental Treatment1 Intervention
Cohort 1 subjects will be dosed 2 mL (26.6 mg) of Liposomal Bupivacaine 13.3. Cohort 2 subjects randomized to the Liposomal Bupivacaine 13.3 arm will be dosed 3 mL (39.9 mg) of Liposomal Bupivacaine 13.3. Cohort 3 subjects randomized to the Liposomal Bupivacaine 13.3 arm will be dosed 4 mL (53.2 mg) of Liposomal Bupivacaine 13.3.
Group II: Bupivacaine ITActive Control1 Intervention
Cohort 1 subjects randomized to the bupivacaine arm will be dosed 2 mL (7.5 mg/ 1 mL) of 0.75% bupivacaine. Cohort 2 subjects randomized to the bupivacaine arm will be dosed 2 mL (7.5 mg/ 1 mL) of 0.75% bupivacaine mixed with 1 mL of preservative free normal saline to create a total volume of solution administered of 3 mL. Cohort 3 subjects randomized to the bupivacaine arm will be dosed 2 mL (7.5 mg / 1 mL) of 0.75% bupivacaine mixed with 2 mL of preservative free normal saline to create a total volume of solution administered of 4 mL.
Group III: PlaceboPlacebo Group1 Intervention
Cohort 1 subjects randomized to the placebo arm will be dosed 2 mL of preservative free normal saline. Cohort 2 subjects randomized to the placebo arm will be dosed 3 mL of preservative free normal saline. Cohort 3 subjects randomized to the placebo arm will be dosed 4 mL of preservative free normal saline.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Liposomal bupivacaine works by encapsulating the local anesthetic bupivacaine in liposomes, which allows for a prolonged release of the drug at the site of administration. This extended release mechanism provides longer-lasting pain relief compared to traditional formulations. For healthy subjects, this is particularly important as it can reduce the need for repeated dosing and minimize systemic side effects, thereby improving overall safety and comfort during clinical trials or minor surgical procedures.
Wound infiltration with liposomal bupivacaine prolongs analgesia in rats.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Pacira Pharmaceuticals, IncLead Sponsor
138 Previous Clinical Trials
13,987 Total Patients Enrolled
Matt Mandel, MDStudy DirectorPacira Pharmaceuticals, Inc
O'Dane BradyStudy DirectorPacira Pharmaceuticals, Inc
Sergey ZaetsStudy DirectorPacira Pharmaceuticals, Inc

Media Library

Liposomal Bupivacaine 13.3 (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT05456490 — Phase 1
Healthy Subjects Research Study Groups: Placebo, Liposomal Bupivacaine 13.3, Bupivacaine IT
Healthy Subjects Clinical Trial 2023: Liposomal Bupivacaine 13.3 Highlights & Side Effects. Trial Name: NCT05456490 — Phase 1
Liposomal Bupivacaine 13.3 (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05456490 — Phase 1
~0 spots leftby Dec 2024