Skip to main content
OpenTrials
Completed

NCT Number: NCT06293807

Immediate Post-Operative Anesthesia With Either Lidocaine or Bupivacaine

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Periodontal Diseases Mouth Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • 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…
  • require IV sedation and local anesthesia or local anesthesia only…
  • in either the maxillary or mandibular arch.

Exclusion criteria

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

Treatment and study plan

Xylocaine 2 % with 1:100,000 epinephrine

Drug

Local anesthetic used during dental procedures

Other names: Lidocaine

Bupivicaine 0.5% with 1:200,000 epinephrine

Drug

Local anesthetic used during dental procedures

Other names: Marcaine

Placebo

Other

0.9% Normal Saline solution used in place of local anesthetic

Other names: Normal Saline 0.9%

Primary outcomes

  1. Change in pain using Visual Analog Scale (VAS)

    Time frame: 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.

  2. Number of Ibuprofen administered

    Time frame: Baseline to 48 hours

    Additive number of ibuprofen taken over monitoring period

  3. Number of Tylenol administered

    Time frame: Baseline to 48 hours

    Additive number of acetaminophen taken over monitoring period

Secondary outcomes

  1. Arch Response

    Time frame: Baseline to 48 hours

    Difference in pain response based upon arch

  2. Number of teeth

    Time frame: Baseline to 48 hours

    Difference in pain response based upon number of teeth per surgical site

  3. Type of procedure

    Time frame: Baseline to 48 hours

    Difference in pain response based upon type of procedure

  4. Gender of patient

    Time frame: Baseline to 48 hours

    Difference in pain response based upon gender of participant

  5. Age of patient

    Time frame: Baseline to 48 hours

    Difference in pain response based upon age of participant

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 5, 2024
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.