Effect of Post-Operative Anesthetics on Post-Operative Pain in Patients Receiving Endodontic Treatment
Primary Purpose
Endodontic Disease, Post Operative Pain, Symptomatic Irreversible Pulpitis
Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Local anesthetic
Sponsored by
About this trial
This is an interventional treatment trial for Endodontic Disease focused on measuring endodontics, root canal, lidocaine, bupivicaine, ibuprofen, symptomatic irreversible pulpitis, post operative pain, heft parker visual analog scale
Eligibility Criteria
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
Sites / Locations
- University of Washington- School of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
2% Lidocaine 1:100,000 epinephrine
0.5% bupivicaine 1:200,000 epinephrine
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05338671
First Posted
June 19, 2021
Last Updated
September 5, 2023
Sponsor
University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT05338671
Brief Title
Effect of Post-Operative Anesthetics on Post-Operative Pain in Patients Receiving Endodontic Treatment
Official Title
Effect of Post-Operative Anesthetics on Post-Operative Pain in Patients Receiving Endodontic Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 29, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontic Disease, Post Operative Pain, Symptomatic Irreversible Pulpitis
Keywords
endodontics, root canal, lidocaine, bupivicaine, ibuprofen, symptomatic irreversible pulpitis, post operative pain, heft parker visual analog scale
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Two different arms each receiving an inferior alveolar nerve block with two different local anesthetics
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
2% Lidocaine 1:100,000 epinephrine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
0.5% bupivicaine 1:200,000 epinephrine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Local anesthetic
Intervention Description
Patients will receive inferior alveolar nerve block injection following endodontic treatment.
Primary Outcome Measure Information:
Title
Post-operative pain level 6 hours on a visual analog scale
Description
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.
Time Frame
Patients will be asked to track pain levels at 6 post-operatively on a visual analog scale
Title
Post-operative pain level 12 hours on a visual analog scale
Description
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.
Time Frame
Patients will be asked to track pain level at 12 hours post-operatively on a visual analog scale
Title
Post-operative pain level 24 hours on a visual analog scale
Description
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.
Time Frame
Patients will be asked to track pain level at 24 hours post-operatively on a visual analog scale
Title
Post-operative pain level 48 hours on a visual analog scale
Description
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.
Time Frame
Patients will be asked to track pain level at 48 hours post-operatively on a visual analog scale
Title
Post-operative pain level 72 hours on a visual analog scale
Description
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.
Time Frame
Patients will be asked to track pain level at 72 hours post-operatively on a visual analog scale
Secondary Outcome Measure Information:
Title
Over the counter analgesic use
Description
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.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Courtney Lang, BS, DDS
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington- School of Dentistry
City
Seattle
State/Province
Washington
ZIP/Postal Code
98112
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24493972
Citation
Al-Kahtani A. Effect of long acting local anesthetic on postoperative pain in teeth with irreversible pulpitis: Randomized clinical trial. Saudi Pharm J. 2014 Jan;22(1):39-42. doi: 10.1016/j.jsps.2013.01.004. Epub 2013 Jan 26.
Results Reference
background
PubMed Identifier
6387029
Citation
Dunsky JL, Moore PA. Long-acting local anesthetics: a comparison of bupivacaine and etidocaine in endodontics. J Endod. 1984 Sep;10(9):457-60. doi: 10.1016/S0099-2399(84)80270-8. No abstract available.
Results Reference
background
PubMed Identifier
24778680
Citation
Moradi S, Naghavi N. Comparison of bupivacaine and lidocaine use for postoperative pain control in endodontics. Iran Endod J. 2010 Winter;5(1):31-5. Epub 2010 Feb 20.
Results Reference
background
PubMed Identifier
22794202
Citation
Parirokh M, Yosefi MH, Nakhaee N, Manochehrifar H, Abbott PV, Reza Forghani F. Effect of bupivacaine on postoperative pain for inferior alveolar nerve block anesthesia after single-visit root canal treatment in teeth with irreversible pulpitis. J Endod. 2012 Aug;38(8):1035-9. doi: 10.1016/j.joen.2012.04.012. Epub 2012 May 30.
Results Reference
background
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Effect of Post-Operative Anesthetics on Post-Operative Pain in Patients Receiving Endodontic Treatment
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