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COMPLETED
NCT07725731
PHASE1/PHASE2

The Anesthetic and Analgesic Effect of Adjunct Liposomal Bupivacaine in Periodontal Surgical Procedures

Sponsor: The University of Texas Health Science Center at San Antonio

View on ClinicalTrials.gov

Summary

Participants are being asked to be a part of this study because they have been scheduled to receive a gum surgery to treat periodontal (gum) disease. After agreeing to participate a pain and medication log will be provided to participants and a 5 minute survey given. Standard of care gum surgery will be done using local anesthesia with or without intravenous sedation according to the participant's preference. If the participant is sedated, they will be asked to have an escort to take them home after the surgery as is the standard of care. At this visit, after the surgery is complete, the doctor will inject the area next to the area that surgery was done surgery with 4 ml (about a teaspoon) of one of two solutions decided by a random 1:1 draw. The participant will receive either liposomal bupivacaine (Exparel) which is a long-acting local anesthetic or 0.5% Bupivacaine HCl with a small amount of epinephrine, a medium-acting dental anesthetic. After surgery, as standard of care, participants will be given instructions on taking over-the-counter medications as needed for pain. Participants will be asked to fill out the pain survey and tablet log at specific times after leaving the clinic. A standard of care follow-up visit with the doctor will be scheduled about 2 weeks after the surgery.

Key Details

Gender

All

Age Range

18 Years - 89 Years

Study Type

INTERVENTIONAL

Enrollment

58

Start Date

2024-10-02

Completion Date

2026-06-02

Last Updated

2026-07-27

Healthy Volunteers

No

Interventions

DRUG

0.5% Bupivacaine HCl

4 ml of bupivacaine 0.5% will be injected adjacent to the surgical site post-surgery

DRUG

Liposomal Bupivacaine (EXPAREL®)/Bupivacaine

4 ml of Liposomal bupivacaine 13.3 mg/ml is injected adjacent to the surgical site post-surgery

Locations (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States