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Completed

NCT Number: NCT07725731

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

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.

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Key information

Conditions

Periodontal Surgery

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

About this study

A randomized, double blinded clinical trial investigating the analgesic and anesthetic effect of liposomal bupivacaine when used after periodontal surgical procedures in addition to standard of care provided local anesthesia. These parameters will be compared to a control group that will receive 0.5% bupivacaine after completion of the procedure during which standard of care local anesthesia will be used.

Primary Objective:

  • Postoperative pain as measured with a Visual Acuity Scale (VAS) (NRS-21)

Secondary Objectives:

  • Time (hours/minutes) for numbness due to local anesthetic to wear off
  • Number of tablets of ibuprofen and acetaminophen consumed

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability of subject to understand and the willingness to sign a written informed consent document.
  • Males and females; Age 18 to 89 years old
  • Require flap surgery of 2 to 5 teeth in a continuous site (including flap debridement, flap osseous, extractions, and Guided Tissue Regeneration (GTR) procedures
  • In either the maxillary or mandibular arch.

Exclusion criteria

  • Pregnancy, or those planning to become pregnant
  • Allergy or any medical issue using Bupivacaine
  • Inability to take non-steroidal anti-inflammatory drugs (NSAIDS) or acetaminophen
  • Non-English speaking
  • Patients requiring narcotic medications for IV sedation
  • Patients requiring either IV or oral steroids during the perioperative period
  • Patients with liver disease

Treatment and study plan

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

Primary outcomes

  1. Post-operative pain measured with Numeric Rating Scale NRS-21 pain scale

    Time frame: 3 to 168 hours

    Pain perceived at regular time intervals using a Visual Analogue Scale (NRS-21) rating their pain at specific time points on a scale from 0 to 10 with 0.5 points in between. A higher score indicates more pain.

Secondary outcomes

  1. Time for numbness to wear off

    Time frame: 3 to 168 hours

    Amount of time in hours/minutes for numbness due to local anesthetic to wear off

  2. Number of of anti-inflammatory tablets taken

    Time frame: Baseline to 7 days

    Number of ibuprofen/Motrin tablets taken post surgery

  3. Number of analgesic tablets taken

    Time frame: Baseline to 7 days

    Number of acetaminophen tablets taken post surgery

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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