What side effects are associated with this type of intervention?

Common side effects of local anesthetics, including those with prolonged action like Liposomal Bupivacaine, can include localized pain at the injection site, swelling, and redness. Systemic side effects, though rare, may involve dizziness, headache, and in severe cases, central nervous system toxicity leading to seizures or cardiovascular issues such as hypotension and arrhythmias. Liposomal formulations are designed to reduce the frequency of dosing and potentially minimize systemic side effects, but localized reactions can still occur.

What prior FDA approvals exist?

Liposomal bupivacaine, designed for prolonged local anesthetic action via liposomal encapsulation, has shown reduced nervous and cardiac toxicity compared to plain bupivacaine solutions. This encapsulation method allows for a safer profile in terms of systemic toxicity. While specific FDA approvals for liposomal bupivacaine in healthy subjects are not detailed, the drug's development aligns with the broader trend of enhancing the safety and efficacy of local anesthetics through advanced delivery systems.

What other types of research exist?

Promising alternatives to Liposomal Bupivacaine for prolonged local anesthetic action include: 1) Continuous intravenous lidocaine infusion, which has shown efficacy in reducing postoperative pain and opioid consumption. 2) Intravesical botulinum toxin A injections, which have demonstrated pain reduction in refractory bladder pain syndrome. 3) Novel formulations of hyaluronic acid fillers with lidocaine, which have been effective in reducing pain during cosmetic procedures. These alternatives have shown potential in clinical trials and may offer effective pain management options in 2024.

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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

Awards & highlights

Study Summary

This trial is testing a new pain medication given as a single injection into the spinal fluid. The goal is to see if it is safe and tolerated by healthy volunteers, and to understand how it works in the body.

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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7-8 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Apparent clearance (CL/F)

Apparent volume of distribution (Vd)

Area under the plasma concentration-versus-time curve (AUC0-last and AUC0- ∞)

+3 more

Secondary outcome measures

Average duration of sensory block and motor block

Average time to onset of sensory block and motor block

Other outcome measures

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.

Do I qualify?Apply below to find out

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.