Immediate Post-Operative Anesthesia With Either Lidocaine or Bupivacaine

The University of Texas System (UT)

Status and phase: Completed; Early Phase 1

Conditions: Periodontal Diseases

Treatments: Drug: Xylocaine 2 % with 1:100,000 epinephrine; Other: Placebo; Drug: Bupivicaine 0.5% with 1:200,000 epinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT06293807

20220162HU

Details and patient eligibility

About

Immediate post-suturing administration of either one of two dental anesthetic solutions or a placebo prior to dismissal.

Full description

This study seeks to evaluate the pain response following the administration of two anesthetic solutions just prior to patient dismissal from a surgical procedure: 2% Xylocaine with 1:100,000 epi and 0.5% Bupivicaine with 1:200,000 epi in comparison with 0.9% Normal Saline as a placebo. the study team will monitor pain response following these interventions at 4, 8, 12, 24, and 48 hours.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

-Patients who have undergone a comprehensive periodontal evaluation and treatment plan not related to participation in this study and...

1. require flap surgery of 2 to 5 teeth in a continuous site (including flap debridement, flap osseous, extractions, and Guided Tissue Regeneration (GTR) procedures), and...
2. require IV sedation and local anesthesia or local anesthesia only...
3. in either the maxillary or mandibular arch.

Exclusion criteria

1. Pregnancy, or those planning to become pregnant
2. allergy or any medical issue using Lidocaine or Bupivacaine
3. inability to take non-steroidal anti-inflammatory drugs (NSAIDS) or acetaminophen
4. non-English speaking
5. not possessing an I-phone or Android device
6. patients requiring narcotic for IV sedation
7. patients requiring either IV or oral steroids during the perioperative period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

72 participants in 3 patient groups, including a placebo group

Treatment group Xylocaine

Experimental group

Description:

Participants have been scheduled to receive an area of gum surgery to treat periodontal (gum) disease in their mouth while under intravenous (IV) conscious sedation. The study drug is administered after surgery.

Treatment:

Drug: Xylocaine 2 % with 1:100,000 epinephrine

Treatment group Bupivicaine

Experimental group

Description:

Participants have been scheduled to receive an area of gum surgery to treat periodontal (gum) disease in their mouth while under intravenous (IV) conscious sedation. The study drug is administered after surgery.

Treatment:

Drug: Bupivicaine 0.5% with 1:200,000 epinephrine

Placebo control group

Placebo Comparator group

Description:

Participants have been scheduled to receive an area of gum surgery to treat periodontal (gum) disease in their mouth while under intravenous (IV) conscious sedation. The study drug is administered after surgery.

Treatment:

Other: Placebo