Immediate Post-Operative Anesthesia With Either Lidocaine or Bupivacaine

Periodontal Diseases Clinical Trial

Official title:

Immediate Post-Operative Anesthesia With Either Lidocaine or Bupivacaine: A Short-term Clinical Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06293807
• Other study ID #: 20220162HU
• Status: Completed
• Phase: Early Phase 1
• Start date: June 6, 2022
• Est. completion date: April 16, 2023

Study information

• Verified date: March 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 16, 2023
• Est. primary completion date: April 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

Drug:
• Xylocaine 2 % with 1:100,000 epinephrine
Local anesthetic used during dental procedures
• Bupivicaine 0.5% with 1:200,000 epinephrine
Local anesthetic used during dental procedures

Other:
• Placebo
0.9% Normal Saline solution used in place of local anesthetic

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain using Visual Analog Scale (VAS)	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.	Baseline to 48 hours
Primary	Number of Ibuprofen administered	Additive number of ibuprofen taken over monitoring period	Baseline to 48 hours
Primary	Number of Tylenol administered	Additive number of acetaminophen taken over monitoring period	Baseline to 48 hours
Secondary	Arch Response	Difference in pain response based upon arch	Baseline to 48 hours
Secondary	Number of teeth	Difference in pain response based upon number of teeth per surgical site	Baseline to 48 hours
Secondary	Type of procedure	Difference in pain response based upon type of procedure	Baseline to 48 hours
Secondary	Gender of patient	Difference in pain response based upon gender of participant	Baseline to 48 hours
Secondary	Age of patient	Difference in pain response based upon age of participant	Baseline to 48 hours