Periodontal Surgery
Conditions
Keywords
Local anesthetic, Pain survey
Brief 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.
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
Interventions
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
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Subjects will be randomized to one of the two groups with simple randomization. Prior to the beginning of the surgical procedure, the PI will request that a faculty member not involved in the case randomly select a sealed envelope with the intervention named inside and hand it to the PI. The PI will prepare the solution selected in a non-labeled syringe and hand it to the surgeon. The surgeon, patient and faculty staffing the case will be blinded as to the contents of the syringe
Intervention model description
Single site randomized controlled, 2 arm trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain measured with Numeric Rating Scale NRS-21 pain scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Time for numbness to wear off | 3 to 168 hours | Amount of time in hours/minutes for numbness due to local anesthetic to wear off |
| Number of of anti-inflammatory tablets taken | Baseline to 7 days | Number of ibuprofen/Motrin tablets taken post surgery |
| Number of analgesic tablets taken | Baseline to 7 days | Number of acetaminophen tablets taken post surgery |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAngela Palaiologou-Gallis, DDS, MS
The University of Texas Health Science Center at San Antonio
Outcome results
None listed