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

Conditions

• Periodontal Surgery

Eligibility Criteria

Sex

ALL

Age

18 Years - 89 Years

Healthy Volunteers

Not accepted

Interventions

• 0.5% Bupivacaine HCl — DRUG
  4 ml of bupivacaine 0.5% will be injected adjacent to the surgical site post-surgery
• Liposomal Bupivacaine (EXPAREL®)/Bupivacaine — DRUG
  4 ml of Liposomal bupivacaine 13.3 mg/ml is injected adjacent to the surgical site post-surgery

Study Details

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 Dates

First listed

Jul 24, 2026

Start date

Oct 2, 2024

Status verified

Jul 2026

Primary completion

Mar 15, 2026

Completion

Jun 2, 2026

Study Design

Enrollment

58 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Adjunctive long acting local anesthesia post surgery
  The experimental group will receive a longer lasting formulation of bupivacaine (liposomal bupivacaine) as an adjunctive local infiltration
• Active Comparator: Adjunctive standard of care local anesthetic
  The control group will receive a commonly used in dentistry local anesthetic (0.5% bupivacaine HCL) as an adjunctive analgesic after the end of the procedure.

Primary Outcome Measure

Post-operative pain measured with Numeric Rating Scale NRS-21 pain scale [ Time Frame: 3 to 168 hours ]

Locations (1)

Find similar trials in San Antonio, TX

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