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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Differences in postoperative milligram morphine equivalents (MME) used between placebo and liposomal bupivacaine
Secondary outcome measures
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I weigh less than 48 kg.I am taking pain medication regularly before surgery.I have liver problems.I have a condition like fibromyalgia or neuropathy that causes me chronic pain.I am 18 years old or older.My BMI is over 40.I had a nose job using my own rib cartilage.I am scheduled for a nose surgery or nose and septum surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Liposomal Bupivacaine
- Group 2: Saline solution
- Group 3: Bupivacaine with epinephrine
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What criteria must prospective participants meet to join this clinical experiment?
"In order to qualify for this trial, potential patients must have undergone a rhinoplasty and be aged between 18 and 99. Currently 72 participants are being sought after."
Answered by AI
Are there any open slots available for participation in this clinical evaluation?
"The clinicaltrials.gov database reveals that this trial, which started on September 1st 2023 and was last updated on July 19th 2023, is not actively searching for patients. Nevertheless, 32 other studies are currently open to recruitment."
Answered by AI
Has the FDA sanctioned Liposomal Bupivacaine for therapeutic use?
"Liposomal Bupivacaine is considered a safe treatment based on the Phase 3 trial data, and was thus scored as a three."
Answered by AI
Is the age limit for participants in this trial above 35 years?
"The lower age limit for this medical trial is set at 18 while the upper-age boundary has been capped at 99."
Answered by AI
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