Immediate Post-Operative Anesthesia With Either Lidocaine or Bupivacaine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-06

Study Completion Date

2023-04-16

Brief Summary

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

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Detailed Description

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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.

Conditions

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Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized, placebo-controlled, parallel design study.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Both the surgeon and patient will be blinded as to the intervention provided by covering identifying marks of the anesthetic carpules to be administered. Randomization will be assured by random selection of a slip of paper drawn from a sealed envelope assigning the patient to one of three groups.

Study Groups

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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.

Group Type EXPERIMENTAL

Xylocaine 2 % with 1:100,000 epinephrine

Intervention Type DRUG

Local anesthetic used during dental procedures

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.

Group Type EXPERIMENTAL

Bupivicaine 0.5% with 1:200,000 epinephrine

Intervention Type DRUG

Local anesthetic used during dental procedures

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

0.9% Normal Saline solution used in place of local anesthetic

Interventions

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Xylocaine 2 % with 1:100,000 epinephrine

Local anesthetic used during dental procedures

Intervention Type DRUG

Bupivicaine 0.5% with 1:200,000 epinephrine

Local anesthetic used during dental procedures

Intervention Type DRUG

Placebo

0.9% Normal Saline solution used in place of local anesthetic

Intervention Type OTHER

Other Intervention Names

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Lidocaine Marcaine Normal Saline 0.9%

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes