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Local Anesthetic

Liposomal Bupivacaine for Pain Management After Nose Job

Phase 3
Waitlist Available
Led By Jessyka Lighthall, MD
Research Sponsored by Jessyka Lighthall
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 6 months
Awards & highlights
Pivotal Trial

Summary

This trial compares post-op pain after nose surgery when using a long-acting anesthetic vs other anesthetics.

Who is the study for?
This trial is for adults over 18 who are having nose surgery (rhinoplasty or septorhinoplasty) and can give written consent. It's not for pregnant women, prisoners, those under 48 kg, with liver issues or high creatinine levels, morbid obesity, cognitive impairments, allergies to local anesthetics/pain meds used in the study, chronic pain medication users before surgery, or those with pre-existing painful conditions.
What is being tested?
The trial tests if liposomal bupivacaine provides better post-surgery pain relief after a nose job compared to standard local anesthesia (0.25% bupivacaine with epinephrine) or placebo (saline solution). Participants will receive one of these treatments randomly.
What are the potential side effects?
Possible side effects include reactions at the injection site like swelling and tenderness. There may also be risks associated with numbness due to nerve blockage from the anesthetic agents.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Differences in postoperative milligram morphine equivalents (MME) used between placebo and liposomal bupivacaine
Secondary study objectives
Difference in adverse events/complications between placebo and test drug
Difference in breathing outcomes between placebo and test drug
Difference in time to first dose of opioid rescue after surgery between placebo and test drug
+1 more

Side effects data

From 2023 Phase 4 trial • 105 Patients • NCT04258631
2%
Spinal headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm II (Laparotomy, Liposomal Bupivacaine, Hydromorphone)
Arm I (Laparotomy, Liposomal Bupivacaine)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Liposomal BupivacaineExperimental Treatment1 Intervention
This group will receive a one time 5 mL injection of liposomal bupivacaine post-operatively at the surgical site.
Group II: Bupivacaine with epinephrineActive Control1 Intervention
This group will receive a one-time 5 mL injection of 0.25% bupivacaine with 1:200,000 epinephrine post-operatively at the surgical site.
Group III: Saline solutionPlacebo Group1 Intervention
This group will receive a one-time 5 mL injection of saline post-operatively at the surgical site.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liposomal Bupivacaine
2016
Completed Phase 4
~1540

Find a Location

Who is running the clinical trial?

Jessyka LighthallLead Sponsor
Jessyka Lighthall, MDPrincipal InvestigatorPenn State Health
1 Previous Clinical Trials
48 Total Patients Enrolled

Media Library

0.25% bupivacaine with 1:200,000 epinephrine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT05964868 — Phase 3
Nose Job Research Study Groups: Liposomal Bupivacaine, Saline solution, Bupivacaine with epinephrine
Nose Job Clinical Trial 2023: 0.25% bupivacaine with 1:200,000 epinephrine Highlights & Side Effects. Trial Name: NCT05964868 — Phase 3
0.25% bupivacaine with 1:200,000 epinephrine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05964868 — Phase 3
~48 spots leftby Dec 2026
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