Immediate Post-Operative Anesthesia With Either Lidocaine or Bupivacaine

March 6, 2024 updated by: The University of Texas Health Science Center at San Antonio

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

72

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • The University of Texas Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group Xylocaine
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.
Drug: Xylocaine 2 % with 1:100,000 epinephrine
Local anesthetic used during dental procedures
Other Names:
  • Lidocaine
Experimental: Treatment group Bupivicaine
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.
Drug: Bupivicaine 0.5% with 1:200,000 epinephrine
Local anesthetic used during dental procedures
Other Names:
  • Marcaine
Placebo Comparator: Placebo control group
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.
Other: Placebo
0.9% Normal Saline solution used in place of local anesthetic
Other Names:
  • Normal Saline 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Ibuprofen administered
Time Frame: Baseline to 48 hours
Additive number of ibuprofen taken over monitoring period
Baseline to 48 hours
Number of Tylenol administered
Time Frame: Baseline to 48 hours
Additive number of acetaminophen taken over monitoring period
Baseline to 48 hours
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.
Baseline to 48 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Investigators

  • Principal Investigator: David Deas, DDS, MS, The University of Texas Health Science Center at San Antonio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2022

Primary Completion (Actual)

April 16, 2023

Study Completion (Actual)

April 16, 2023

Study Registration Dates

First Submitted

February 27, 2024

First Submitted That Met QC Criteria

February 27, 2024

First Posted (Actual)

March 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20220162HU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The PI will share all collected deidentified IPD, all deidentified IPD that underlie results in a publication with colleagues.

IPD Sharing Time Frame

Data will be shared at the time of publication in a peer reviewed journal after the study has completed.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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