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

Phase 4

Completed

• Conditions: Endodontic Disease; Post Operative Pain; Symptomatic Irreversible Pulpitis
• Interventions: Drug: Local anesthetic

• Registration Number: NCT05338671
• Lead Sponsor: University of Washington

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-06-19
• Study Start: 2021-09-29
• Study First Submitted QC: 2022-04-15
• Study First Posted: 2022-04-21
• Status Verified: 2024-02
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Diagnosis of symptomatic irreversible pulpitis on mandibular, posterior tooth
• ASA I or II
• >18 years old

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2% Lidocaine 1:100,000 epinephrine	Local anesthetic	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.
0.5% bupivicaine 1:200,000 epinephrine	Local anesthetic	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.

Primary Outcome Measures

Name	Time	Method
Post-operative pain level 6 hours on a visual analog scale	Patients will be asked to track pain levels at 6 post-operatively 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.
Post-operative pain level 12 hours on a visual analog scale	Patients will be asked to track pain level at 12 hours post-operatively 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.
Post-operative pain level 24 hours on a visual analog scale	Patients will be asked to track pain level at 24 hours post-operatively 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.
Post-operative pain level 48 hours on a visual analog scale	Patients will be asked to track pain level at 48 hours post-operatively 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.
Post-operative pain level 72 hours on a visual analog scale	Patients will be asked to track pain level at 72 hours post-operatively 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.

Secondary Outcome Measures

Name	Time	Method
Over the counter analgesic use	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.	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.

Trial Locations

Locations (1)

University of Washington- School of Dentistry; 🇺🇸 Seattle, Washington, United States