Liposomal Bupivacaine for Pain Management After Nose Job

Recruiting in Palo Alto (17 mi)

Overseen byJessyka Lighthall, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Jessyka Lighthall

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?The objective of this study is to determine if there is a difference in post-operative pain after septorhinoplasty when long-acting liposomal bupivacaine is used for local anesthesia compared to other standard local anesthetic regimens.

Eligibility Criteria

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.

Inclusion Criteria

Written informed consent must be obtained

I am 18 years old or older.

I am scheduled for a nose surgery or nose and septum surgery.

Exclusion Criteria

Patients with hypersensitivity to local anesthetics and pain medications used in the study

I weigh less than 48 kg.

I am taking pain medication regularly before surgery.

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Participant Groups

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.

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.