Supplemental Postoperative Bupivacaine Following Non-Surgical Endodontic Treatment

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Quality of life (scored based on the OHIP-14 questionnaire) [Срок оценки: Day of operation and daily for four days immediately following endodontic treatment]

Вторичные конечные точки (2)

• Postoperative pain level [Срок оценки: Day of operation and daily for four days immediately following endodontic treatment]
• Analgesic use [Срок оценки: Day of operation and daily for four days immediately following endodontic treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• New York University College of Dentistry — New York

Идентификаторы

NCT: NCT06655454 · i24-01018

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗