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

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05338671
• Other study ID #: STUDY00013406
• Status: Recruiting
• Phase: Phase 4
• Start date: September 29, 2021
• Est. completion date: May 2024

Study information

• Verified date: February 2024
• Source: University of Washington
• Contact: Courtey Lang, BS, DDS
• Phone: 971-708-1098
• Email: clang19[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Pulp Diseases
• Endodontic Disease
• Pain, Postoperative
• Post Operative Pain
• Pulpitis
• Symptomatic Irreversible Pulpitis

Intervention

Drug:
• Local anesthetic
Patients will receive inferior alveolar nerve block injection following endodontic treatment.

Locations

Country	Name	City	State
United States	University of Washington- School of Dentistry	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.