Supplemental Postoperative Bupivacaine Following Non-Surgical Endodontic Treatment
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNew York University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Supplemental Postoperative Bupivacaine
DrugThis is the intervention of interest. A supplemental injection of bupivacaine will be given postoperatively to patients who are assigned this intervention.
Placebo Injection
DrugThis intervention will appear to give patients an additional injection, but no additional drug will be given.
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Supplemental Postoperative BupivacaineExperimental treatment 1 intervention
Group B: Mock/Placebo InjectionPlacebo comparator 1 intervention
Group C: No Additional InjectionNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Quality of life (scored based on the OHIP-14 questionnaire)
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.
Time frame
Day of operation and daily for four days immediately following endodontic treatmentSecondary outcomes
1
Postoperative pain level
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.
Time frame
Day of operation and daily for four days immediately following endodontic treatment2
Analgesic use
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.
Time frame
Day of operation and daily for four days immediately following endodontic treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov