Extra pain relief after root canal 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
This study tests if an extra pain relief injection after a root canal can help people feel less pain and recover better compared to those who get a placebo or no extra anesthetic.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | New York University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06655454 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of an additional injection of long-acting bupivacaine on pain levels, quality of life, and analgesic use following nonsurgical endodontic treatment for symptomatic irreversible pulpitis. Participants will be divided into three groups: one receiving bupivacaine, one receiving a placebo injection, and one receiving no additional anesthetic. The study aims to determine if the supplemental anesthetic significantly reduces pain and improves recovery outcomes compared to the other groups.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with symptomatic irreversible pulpitis and pre-operative pain levels of 5 or above on a 0-10 scale.
Not a fit: Patients with severe medical conditions (ASA Class III or above), those using tobacco or illicit drugs, or pregnant individuals may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved pain management and quality of life for patients undergoing root canal therapy.
How similar studies have performed: Other studies have shown positive outcomes with similar approaches to postoperative pain management, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
New York, New York
- New York University College of Dentistry — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Lorel E Burns, DDS
- Email: leb409@nyu.edu
- Phone: 212-998-9332
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.