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

Sponsor
University of Washington (Other)
Overall Status
Recruiting
CT.gov ID
NCT05338671
Collaborator
(none)
40
1
2
7
5.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Local anesthetic
Phase 4

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

  1. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two different arms each receiving an inferior alveolar nerve block with two different local anestheticsTwo different arms each receiving an inferior alveolar nerve block with two different local anesthetics
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effect of Post-Operative Anesthetics on Post-Operative Pain in Patients Receiving Endodontic Treatment
Actual Study Start Date :
Sep 29, 2021
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 2% Lidocaine 1:100,000 epinephrine

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
Patients will receive inferior alveolar nerve block injection following endodontic treatment.

Active Comparator: 0.5% bupivicaine 1:200,000 epinephrine

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
Patients will receive inferior alveolar nerve block injection following endodontic treatment.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Washington- School of Dentistry Seattle Washington United States 98112

Sponsors and Collaborators

  • University of Washington

Investigators

  • Principal Investigator: Jordan Johnson, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jordan Johnson, Resident in Graduate Endodontics, University of Washington
ClinicalTrials.gov Identifier:
NCT05338671
Other Study ID Numbers:
  • STUDY00013406
First Posted:
Apr 21, 2022
Last Update Posted:
Apr 21, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Jordan Johnson, Resident in Graduate Endodontics, University of Washington
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 21, 2022