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NCT Number: NCT06655454

Supplemental Postoperative Bupivacaine Following Non-Surgical Endodontic Treatment

The study will investigate the impact of an additional injection of long-acting anesthetic on pain level, quality of life, and use of pain medication after a nonsurgical endodontic treatment. The long-acting anesthetic will be compared to a mock injection group and a group with no additional anesthetic to determine any differences in effects.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

New York University College of Dentistry

New York, 10010, United States

Location status: Recruiting

Location contact

Lorel E Burns, DDS

PRINCIPAL_INVESTIGATOR

Lorel E Burns, DDS, MS

CONTACT

[email protected]

212-998-9332

About this study

The study will investigate the impact of postoperative supplemental long-acting bupivacaine on patient's pain, quality of life, and analgesic use following treatment for symptomatic irreversible pulpitis on patients with pre-operative pain levels of 5 or above (on a 0-10 analog scale). Bupivacaine will be compared to a placebo/mock injection and no injection to determine the difference in effect.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Medical ASA Class I or II
  • Patients above 18 years old
  • Patients with a blood pressure below 160/100
  • Patients who are treatment planned and have agreed to have emergency endodontic therapy or non-surgical root canal therapy with a pulpal diagnosis of symptomatic irreversible pulpitis according to the AAE Glossary of Endodontic Terms.
  • Patients must be able to comprehend and complete all study protocols, written consent, and questionnaires in English.

Exclusion criteria

  • Medical ASA III or above
  • Patients who reported the use of tobacco or nicotine-containing products such as vapes, e-cigarettes, gums, or pouches and will not in the 48 hours following treatment
  • Patients who reported the use of any marijuana products or illicit drugs in the 48 hours prior to treatment and will not in the next 48 hours.
  • Patients who have taken opioids to control pain.
  • Pregnant patients
  • Patients with a blood pressure of 160/100 or greater
  • Patients with a known hypersensitivity or allergy to any local anesthetic agent of the amide group, or any other components of the two anesthetic solutions such as epinephrine, sodium metabisulfite used in the study.
  • Patients who have more than one tooth with odontogenic pain at the time of the screening.
  • Patients who are unable to consent and do not understand or are unable to read the questionnaires.
  • Patients who have had 4 1.7 ml carpules or more of anesthetic (Lidocaine and/ or Septocaine, 1:100,000) during standard care of treatment.

Treatment and study plan

Supplemental Postoperative Bupivacaine

Drug

This is the intervention of interest. A supplemental injection of bupivacaine will be given postoperatively to patients who are assigned this intervention.

Placebo injection

Drug

This intervention will appear to give patients an additional injection, but no additional drug will be given.

Primary outcomes

  1. Quality of life (scored based on the OHIP-14 questionnaire)

    Time frame: Day of operation and daily for four days immediately following endodontic treatment

    Quality of life will be measured with a modified version of the OHIP-14 questionnaire.

    For each question, the answers correspond with a scale that runs from 0-4. A higher score corresponds with a lower quality of life, with 0 being great quality of life and 4 being very poor quality of life.

Secondary outcomes

  1. Postoperative pain level

    Time frame: Day of operation and daily for four days immediately following endodontic treatment

    Pain level as measured by the visual-analog scale (VAS) will be collected for four days following endodontic treatment.

    The scale is from 0-10, with 0 being no pain and 10 being the worst pain possible.

  2. Analgesic use

    Time frame: Day of operation and daily for four days immediately following endodontic treatment

    Use of self-administered analgesics including opioids will be measured postoperatively.

    The measure is binary- either usage of self-administered analgesics or no usage of self-administered analgesics.

Study contacts

Contact information is provided by the study sponsor or research team.

Lorel E Burns, DDS

CONTACT

[email protected]

212-998-9332

NYUSOM IRB

CONTACT

[email protected]

212-263-4110

Sponsors and collaborators

Lead sponsor

New York University

Other

Registry information

Official study title

The Effects of Supplemental Postoperative 0.5% Bupivacaine With 1:200,000 Epinephrine Following Non-Surgical Endodontic Treatment on Patients' Quality of Life, Pain, and Analgesic Consumption

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 23, 2024
Registry last updated
Apr 13, 2026

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.

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