Clinical trial NCT05338671: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: 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
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two different arms each receiving an inferior alveolar nerve block with two different local anesthetics
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Post-operative Pain Level 6 Hours on a Visual Analog Scale
timeFrame: Patients will be asked to track pain levels at 6 post-operatively on a visual analog scale
measure: Post-operative Pain Level 12 Hours on a Visual Analog Scale
timeFrame: Patients will be asked to track pain level at 12 hours post-operatively on a visual analog scale
measure: Post-operative Pain Level 24 Hours on a Visual Analog Scale
timeFrame: Patients will be asked to track pain level at 24 hours post-operatively on a visual analog scale
measure: Post-operative Pain Level 48 Hours on a Visual Analog Scale
timeFrame: Patients will be asked to track pain level at 48 hours post-operatively on a visual analog scale
measure: Post-operative Pain Level 72 Hours on a Visual Analog Scale
timeFrame: Patients will be asked to track pain level at 72 hours post-operatively on a visual analog scale
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington- School of Dentistry
state: Washington
Study officials:
affiliation: University of Washington
name: Avina Paranjpe
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.