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Local Anesthetic
Bupivacaine and Liposomal Bupivacaine for Postoperative Pain
Phase 4
Waitlist Available
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 96 hours post-operatively
Awards & highlights
Study Summary
This trial will study a new painkiller (Exparel) to reduce pain after third molar extractions and lower the need for extra painkillers.
Eligible Conditions
- Postoperative Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 96 hours post-operatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~96 hours post-operatively
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Post-operative pain
Secondary outcome measures
Adverse effects
Anti-Inflammatory Agents, Non-Steroidal
Oxycodone Use
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Liposomal bupivacaineExperimental Treatment1 Intervention
A double-blinded randomization process will be used to preoperatively assign patient's left or right side to receive either Exparel (Liposomal bupivacaine) (39.9 mg/3 mL) or standard bupivacaine (5 mg/mL). At the end of the mandibular third molar extraction surgical procedure and at least twenty minutes following the most recent administration of 2% lidocaine with 1:100,000 epinephrine (routine for this procedure), all patients will receive one side of their mandibular infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel).
Group II: 0.5% bupivacaine with 1:200,000 epinephrineActive Control1 Intervention
A double-blinded randomization process will be used to preoperatively assign patient's left or right side to receive either Exparel (Liposomal bupivacaine) (39.9 mg/3 mL) or standard bupivacaine (5 mg/mL). At the end of the procedure and at least twenty minutes following the most recent administration of 2% lidocaine with 1:100,000 epinephrine (routine for this procedure), all patients will receive one side of their mandibular infiltrations with 3mL of diluted 0.5% bupivacaine with 1:200,000 epinephrine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liposomal bupivacaine
2016
Completed Phase 4
~1970
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
905 Previous Clinical Trials
1,596,278 Total Patients Enrolled
1 Trials studying Postoperative Pain
80 Patients Enrolled for Postoperative Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious liver disease.You have taken antibiotics in the last 30 days.You have used certain pain medications in the 3 days before the screening.You are having other teeth removed from your lower jaw.You are having surgery to remove both of your back wisdom teeth at a specific dental school.You have had a bad reaction to certain pain medications in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Liposomal bupivacaine
- Group 2: 0.5% bupivacaine with 1:200,000 epinephrine
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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 have been the reported side effects of Liposomal bupivacaine?
"Based on the Phase 4 trial data, Liposomal bupivacaine has been deemed safe enough to be approved and is thus awarded a score of 3."
Answered by AI
Are there any openings in this research endeavor at the moment?
"As per the clinicaltrials.gov data, this trial is not in need of applicants at present - it was posted on September 1st 2022 and last updated on May 5th 2023. However, there are presently 497 other studies actively enlisting patients."
Answered by AI
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