A Phase 1/2 interventional study of 0.5% Bupivacaine HCl and Liposomal Bupivacaine (EXPAREL®)/Bupivacaine in Periodontal Surgery, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by The University of Texas Health Science Center at San Antonio · Phase 1/2, Interventional, and Treatment
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.
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:
The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.
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Exclusion Criteria:
The experimental group will receive a longer lasting formulation of bupivacaine (liposomal bupivacaine) as an adjunctive local infiltration
Drug: Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
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
4 ml of Liposomal bupivacaine 13.3 mg/ml is injected adjacent to the surgical site post-surgery
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.
Time frame: 3 to 168 hours
Time for numbness to wear off
Amount of time in hours/minutes for numbness due to local anesthetic to wear off
Time frame: 3 to 168 hours
Number of of anti-inflammatory tablets taken
Number of ibuprofen/Motrin tablets taken post surgery
Time frame: Baseline to 7 days
Number of analgesic tablets taken
Number of acetaminophen tablets taken post surgery
Time frame: Baseline to 7 days
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center at San Antonio