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 your preference. If you are sedated, you will be asked to have an escort to take you home after the surgery as is the standard of care.

At this visit, after your surgery is complete, your 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. You 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 your doctor will be scheduled about 2 weeks after your surgery.

Study Overview

• Status: Completed
• Conditions: Periodontal Surgery
• Intervention / Treatment: Drug: Liposomal Bupivacaine (EXPAREL®)/Bupivacaine; Drug: 0.5% Bupivacaine HCl

Detailed Description

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:

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

   Secondary Objectives:

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

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center at San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Liposomal Bupivacaine (EXPAREL®)/Bupivacaine; 4 ml of Liposomal bupivacaine 13.3 mg/ml is injected adjacent to the surgical site post-surgery
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.	Drug: 0.5% Bupivacaine HCl; 4 ml of bupivacaine 0.5% will be injected adjacent to the surgical site post-surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain measured with Numeric Rating Scale NRS-21 pain scale	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.	3 to 168 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time for numbness to wear off	Amount of time in hours/minutes for numbness due to local anesthetic to wear off	3 to 168 hours
Number of of anti-inflammatory tablets taken	Number of ibuprofen/Motrin tablets taken post surgery	Baseline to 7 days
Number of analgesic tablets taken	Number of acetaminophen tablets taken post surgery	Baseline to 7 days

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Investigators: Principal Investigator: Angela Palaiologou-Gallis, DDS, MS, The University of Texas Health Science Center at San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2024
• Primary Completion (Actual): March 15, 2026
• Study Completion (Actual): June 2, 2026

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Local anesthetic; Pain survey
• Additional Relevant MeSH Terms: Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Bupivacaine
• Other Study ID Numbers: STUDY00000764

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The PI will ensure all mechanisms used to share data will include proper plans and safeguards for the protection of privacy, confidentiality, and security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be traceable to a specific study participant). Plans for archiving and long-term preservation of the data will be implemented, as appropriate.
• IPD Sharing Time Frame: After study completion and data analysis and acceptance by a peer review journal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No