Supplemental Postoperative Bupivacaine Following Non-Surgical Endodontic Treatment

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain Assessment; Quality of Life (QOL); Analgesic Use
• Intervention / Treatment: Drug: Supplemental Postoperative Bupivacaine; Drug: Placebo Injection

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lorel E Burns, DDS; Phone Number: 212-998-9332; Email: leb409@nyu.edu
• Study Contact Backup: Name: NYUSOM IRB; Phone Number: 212-263-4110; Email: irb-info@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10010
      • Recruiting
      • New York University College of Dentistry
      • Contact: Lorel E Burns, DDS, MS; Phone Number: 212-998-9332; Email: leb409@nyu.edu
      • Principal Investigator: Lorel E Burns, DDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Medical ASA Class I or II
2. Patients above 18 years old
3. Patients with a blood pressure below 160/100
4. 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.
5. Patients must be able to comprehend and complete all study protocols, written consent, and questionnaires in English.

Exclusion Criteria:

1. Medical ASA III or above
2. 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
3. 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.
4. Patients who have taken opioids to control pain.
5. Pregnant patients
6. Patients with a blood pressure of 160/100 or greater
7. 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.
8. Patients who have more than one tooth with odontogenic pain at the time of the screening.
9. Patients who are unable to consent and do not understand or are unable to read the questionnaires.
10. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supplemental Postoperative Bupivacaine; An additional injection, 1 carpule (1.8 mL) of 0.5% bupivacaine with 1:200,000 epinephrine, will be given to patients in this treatment arm, after their standard endodontic procedure is complete.	Drug: Supplemental Postoperative Bupivacaine; This is the intervention of interest. A supplemental injection of bupivacaine will be given postoperatively to patients who are assigned this intervention.
Placebo Comparator: Mock/Placebo Injection; If assigned to this arm, the patient will be shown the removal of a needle cap for an anesthetic syringe. The tip will be bent and placed in the patient's mouth, but no tissue penetration will occur. No solution of anesthetic will be delivered.	Drug: Placebo Injection; This intervention will appear to give patients an additional injection, but no additional drug will be given.
No Intervention: No Additional Injection; After standard endodontic procedure, no additional injection will be given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life (scored based on the OHIP-14 questionnaire)	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.	Day of operation and daily for four days immediately following endodontic treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain level	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.	Day of operation and daily for four days immediately following endodontic treatment
Analgesic use	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.	Day of operation and daily for four days immediately following endodontic treatment

Collaborators and Investigators

• Sponsor: New York University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: bupivacaine; pain management; root canal therapy; irreversible pulpitis; nonsurgical endodontic treatment; anesthetic use
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• Other Study ID Numbers: i24-01018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No