Bupivacaina postoperatoria supplementare dopo trattamento endodontico non chirurgico
Gli effetti della supplementazione postoperatoria di bupivacaina allo 0,5% con adrenalina 1:200.000 in seguito a trattamento endodontico non chirurgico sulla qualità di vita, sul dolore e sul consumo di analgesici dei pazienti
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 2
Contatti e Sedi
Contatto studio
- Nome: Lorel E Burns, DDS
- Numero di telefono: 212-998-9332
- Email: leb409@nyu.edu
Backup dei contatti dello studio
- Nome: NYUSOM IRB
- Numero di telefono: 212-263-4110
- Email: irb-info@nyulangone.org
Luoghi di studio
-
-
New York
-
New York, New York, Stati Uniti, 10010
- Reclutamento
- New York University College of Dentistry
-
Contatto:
- Lorel E Burns, DDS, MS
- Numero di telefono: 212-998-9332
- Email: leb409@nyu.edu
-
Investigatore principale:
- Lorel E Burns, DDS
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
This is the intervention of interest. A supplemental injection of bupivacaine will be given postoperatively to patients who are assigned this intervention. |
|
Comparatore placebo: 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. |
This intervention will appear to give patients an additional injection, but no additional drug will be given. |
|
Nessun intervento: No Additional Injection
After standard endodontic procedure, no additional injection will be given. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Quality of life (scored based on the OHIP-14 questionnaire)
Lasso di tempo: 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. |
Day of operation and daily for four days immediately following endodontic treatment
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Postoperative pain level
Lasso di tempo: 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. |
Day of operation and daily for four days immediately following endodontic treatment
|
|
Analgesic use
Lasso di tempo: 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. |
Day of operation and daily for four days immediately following endodontic treatment
|
Collaboratori e investigatori
Sponsor
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Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- i24-01018
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