Supplemental Postoperative Bupivacaine Following Non-Surgical Endodontic Treatment

Phase 2

Recruiting

• Conditions: Pain Assessment; Quality of Life (QOL); Analgesic Use
• Interventions: Drug: Placebo Injection; Drug: Supplemental Postoperative Bupivacaine

• Registration Number: NCT06655454
• Lead Sponsor: New York University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-10-21
• Study First Submitted QC: 2024-10-21
• Study First Posted: 2024-10-23
• Status Verified: 2024-11
• Study Start: 2024-11-01
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mock/Placebo Injection	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.
Supplemental Postoperative Bupivacaine	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.

Primary Outcome Measures

Name	Time	Method
Quality of life	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 Outcome Measures

Name	Time	Method
Postoperative pain level	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.
Analgesic use	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.

Trial Locations

Locations (1)

New York University College of Dentistry; 🇺🇸 New York, New York, United States