Immediate Post-Operative Anesthesia With Either Lidocaine or Bupivacaine

Early Phase 1

Completed

• Conditions: Periodontal Diseases
• Interventions: Other: Placebo

• Registration Number: NCT06293807
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2022-06-06
• Primary Completion: 2023-04-16
• Study Completion: 2023-04-16
• Study First Submitted: 2024-02-27
• Study First Submitted QC: 2024-02-27
• Status Verified: 2024-03
• Study First Posted: 2024-03-05
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo control group	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Number of Ibuprofen administered	Baseline to 48 hours	Additive number of ibuprofen taken over monitoring period
Change in pain using Visual Analog Scale (VAS)	Baseline to 48 hours	Pain response recorded using a 20 point visual Analog Scale. The VAS scale is a straight line scale scored from 0-20 with 0 indicating the least amount of pain and 20 the worst pain ever experienced.
Number of Tylenol administered	Baseline to 48 hours	Additive number of acetaminophen taken over monitoring period

Secondary Outcome Measures

Name	Time	Method
Type of procedure	Baseline to 48 hours	Difference in pain response based upon type of procedure
Arch Response	Baseline to 48 hours	Difference in pain response based upon arch
Number of teeth	Baseline to 48 hours	Difference in pain response based upon number of teeth per surgical site
Gender of patient	Baseline to 48 hours	Difference in pain response based upon gender of participant
Age of patient	Baseline to 48 hours	Difference in pain response based upon age of participant

Trial Locations

Locations (1)

The University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States