Pain AssessmentPhase 2NCT06655454
Supplemental Postoperative Bupivacaine Following Non-Surgical Endodontic Treatment
A Phase 2 study testing Supplemental Postoperative Bupivacaine in people with Pain Assessment and Quality of Life (QOL), run by New York University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Assessment, Quality of Life (QOL), Analgesic Use
- What is being tested?
- Supplemental Postoperative Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
New York University College of Dentistry
New York, New York, 10010
Lorel E Burns, DDS, MS, 212-998-9332, leb409@nyu.edu
Lorel E Burns, DDS
About this study
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
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.
Read the 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.
- Conditions
- Pain Assessment, Quality of Life (QOL), Analgesic Use
- Being tested
- Supplemental Postoperative Bupivacaine, Placebo Injection
- Keywords
- bupivacaine, nonsurgical endodontic treatment, root canal therapy, irreversible pulpitis, pain management, anesthetic use
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplemental Postoperative BupivacaineDrug
This is the intervention of interest. A supplemental injection of bupivacaine will be given postoperatively to patients who are assigned this intervention.
Placebo InjectionDrug
This intervention will appear to give patients an additional injection, but no additional drug will be given.
| Study group | Role | What they receive |
|---|---|---|
| Supplemental Postoperative Bupivacaine | Experimental | 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. Receives: Drug: Supplemental Postoperative Bupivacaine |
| Mock/Placebo Injection | Placebo comparator | 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. Receives: Drug: Placebo Injection |
| No Additional Injection | No intervention | After standard endodontic procedure, no additional injection will be given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day of operation and daily for four days immediately following endodontic treatment
Secondary outcomes (2)
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.
Measured: Day of operation and daily for four days immediately following endodontic treatment
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.
Measured: Day of operation and daily for four days immediately following endodontic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start1 Nov 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain AssessmentStudies of the same condition, open and under way.
- More trials run by New York UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655454
- Sponsor's protocol ID
- i24-01018
- Status last verified
- Apr 2026
- First submitted
- 21 Oct 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06655454
- Acronym / sponsor ID
- i24-01018
- Conditions
- Pain Assessment, Quality of Life (QOL), Analgesic Use
- Keywords
- bupivacaine, nonsurgical endodontic treatment, root canal therapy, irreversible pulpitis, pain management, anesthetic use
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Supplemental Postoperative Bupivacaine | Experimental | Drug: Supplemental Postoperative BupivacaineAn 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. |
| Mock/Placebo Injection | Placebo comparator | Drug: Placebo InjectionIf 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. |
| No Additional Injection | No intervention | –After standard endodontic procedure, no additional injection will be given. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supplemental Postoperative BupivacaineThis is the intervention of interest. A supplemental injection of bupivacaine will be given postoperatively to patients who are assigned this intervention. | Drug | Supplemental Postoperative Bupivacaine |
| Placebo InjectionThis intervention will appear to give patients an additional injection, but no additional drug will be given. | Drug | Mock/Placebo Injection |
Primary outcome
Quality of life (scored based on the OHIP-14 questionnaire)
Time frame: 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.
2 secondary outcomes
Postoperative pain level
Time frame: Day of operation and daily for four days immediately following endodontic treatment
Analgesic use
Time frame: Day of operation and daily for four days immediately following endodontic treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Supplemental Postoperative Bupivacaine in people with Pain Assessment and Quality of Life (QOL), run by New York University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorel E Burns, DDS (212-998-9332, leb409@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (scored based on the OHIP-14 questionnaire) (time frame: Day of operation and daily for four days immediately following endodontic treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.