Effect of Post-Operative Anesthetics on Post-Operative Pain in Patients Receiving Endodontic Treatment

Study Overview
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Brief Summary
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This study will assess the efficacy of two local anesthetics (2% lidocaine 1:100,000 epinephrine and 0.5% bupivicaine 1:200,000 epinephrine) in reducing post-operative pain in patients receiving endodontic treatment.

Detailed Description
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The goal of this study is to assess the efficacy of 2% lidocaine 1:100,000 epinephrine and 0.5% bupivicaine 1:200,000 epinephrine in reducing post-operative pain in patients with symptomatic irreversible pulpitis on a mandibular tooth that receive endodontic treatment. Participants of this study will include patients that present to the University of Washington Endodontic clinic and fit the inclusion criteria of being >18 years old, healthy (ASA I or II) and having a diagnosis of symptomatic irreversible pulpitis on a mandibular tooth, that is willing to undergo endodontic treatment in two visits. Upon diagnosis, and informed consent, patients will be asked to participate in this study. If enrolled in the study, participants will receive standard endodontic treatment with temporary placement of Calcium Hydroxide medicament within the canals of the tooth and placement of a temporary filling. They will then be randomized to receive an inferior alveolar nerve block with 1 cartridge (1.8mL) of either 2% lidocaine 1:100,000 epinephrine or 0.5% bupivicaine 1:200,000 epinephrine. Patients will be given a form to track their pain levels for the next 72 hours, that they will return at a follow up visit. This form will use the Heft-Parker visual analog pain scale to track pain levels as well as ask participants to track their use of over the counter analgesics, in particular, Advil/ibuprofen. The pain tracking form will be returned to the clinic and root canal will be completed also at this follow up visit.

Official Title
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Effect of Post-Operative Anesthetics on Post-Operative Pain in Patients Receiving Endodontic Treatment

Conditions
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Endodontic Disease, Post Operative Pain, Symptomatic Irreversible Pulpitis

Intervention / Treatment
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* Drug: Local anesthetic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of symptomatic irreversible pulpitis on mandibular, posterior tooth ASA I or II >18 years old Exclusion Criteria: Maxillary or mandibular anterior tooth Diagnosis of pulp necrosis or reversible pulpitis Tooth deemed non-restorable <18 years old ASA III, IV, or V Patients who are contraindicated to take ibuprofen Patients with allergies to any medications being assessed in this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two different arms each receiving an inferior alveolar nerve block with two different local anesthetics
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2% Lidocaine 1:100,000 epinephrine<br>Participants in this arm will receive an inferior alveolar nerve block with 1 cartridge (1.8 mL) of 2% Lidocaine 1:100,000 epinephrine following endodontic treatment. | Drug: Local anesthetic<br>* Patients will receive inferior alveolar nerve block injection following endodontic treatment.<br>|
| Active Comparator: 0.5% bupivicaine 1:200,000 epinephrine<br>Participants in this arm will receive an inferior alveolar nerve block with 1 cartridge (1.8 mL) of 0.5% bupivicaine 1:200,000 epinephrine following endodontic treatment. | Drug: Local anesthetic<br>* Patients will receive inferior alveolar nerve block injection following endodontic treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain level 6 hours on a visual analog scale | Participants will be asked to track the amount of pain they have following their endodontic treatment using the Heft-Parker visual analog scale with scores ranging from 0-170 with higher scores signifying more pain. | Patients will be asked to track pain levels at 6 post-operatively on a visual analog scale | 
| Post-operative pain level 12 hours on a visual analog scale | Participants will be asked to track the amount of pain they have following their endodontic treatment using the Heft-Parker visual analog scale with scores ranging from 0-170 with higher scores signifying more pain. | Patients will be asked to track pain level at 12 hours post-operatively on a visual analog scale | 
| Post-operative pain level 24 hours on a visual analog scale | Participants will be asked to track the amount of pain they have following their endodontic treatment using the Heft-Parker visual analog scale with scores ranging from 0-170 with higher scores signifying more pain. | Patients will be asked to track pain level at 24 hours post-operatively on a visual analog scale | 
| Post-operative pain level 48 hours on a visual analog scale | Participants will be asked to track the amount of pain they have following their endodontic treatment using the Heft-Parker visual analog scale with scores ranging from 0-170 with higher scores signifying more pain. | Patients will be asked to track pain level at 48 hours post-operatively on a visual analog scale | 
| Post-operative pain level 72 hours on a visual analog scale | Participants will be asked to track the amount of pain they have following their endodontic treatment using the Heft-Parker visual analog scale with scores ranging from 0-170 with higher scores signifying more pain. | Patients will be asked to track pain level at 72 hours post-operatively on a visual analog scale | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Over the counter analgesic use | Patients will be asked to track the amount of ibuprofen or other over the counter analgesics they use to help manage their post-operative pain levels. | Patients will be asked to track total analgesic use 72 hours post-operatively, and to record times and amounts of use during the 72 hour window in which they are recording their pain levels. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endodontics, root canal, lidocaine, bupivicaine, ibuprofen, symptomatic irreversible pulpitis, post operative pain, heft parker visual analog scale