Supplemental Postoperative Bupivacaine Following Non-Surgical Endodontic Treatment
Pain Assessment · Quality of Life (QOL) · Analgesic Use
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- Fase 2
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 150 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
Leer la descripción completa
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
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.
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento simple
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
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
No Additional Injection
After standard endodontic procedure, no additional injection will be given.
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.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Quality of life (scored based on the OHIP-14 questionnaire)
Plazo: 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.
Medidas secundarias
Postoperative pain level
Plazo: 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
Plazo: 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.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
New York University College of DentistryNew York, New York, United StatesReclutando
Equipo y fechas
- Patrocinador principal
- New York University
- Inicio del estudio
- 1 nov 2024 Real
- Finalización primaria
- 31 may 2027 Estimado
- Finalización del estudio
- 31 may 2027 Estimado
- Primera publicación
- 23 oct 2024 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
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
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026