Clinical trial NCT06655454: Supplemental Postoperative Bupivacaine Following Non-Surgical Endodontic Treatment
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pain Assessment
Quality of Life (QOL)
Analgesic Use
Keywords: bupivacaine
nonsurgical endodontic treatment
root canal therapy
irreversible pulpitis
pain management
anesthetic use
Lead sponsor: New York University
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three types of additional treatment after standard nonsurgical endodontic procedures may be given. These include an additional injection of bupivacaine, an additional mock or placebo injection, and no additional injection.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Quality of life
timeFrame: Day of operation and daily for four days immediately following endodontic treatment
Secondary outcomes:
measure: Postoperative pain level
timeFrame: Day of operation and daily for four days immediately following endodontic treatment
measure: Analgesic use
timeFrame: Day of operation and daily for four days immediately following endodontic treatment
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University College of Dentistry
state: New York
Study officials:
References: