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

NCT05338671 | Completed Phase 4 Results FDA Drug

• 1 other identifier: STUDY00013406
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

2% Lidocaine 1:100,000 epinephrine

ACTIVE COMPARATOR

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

0.5% bupivicaine 1:200,000 epinephrine

ACTIVE COMPARATOR

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

Interventions

Local anesthetic DRUG

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

0.5% bupivicaine 1:200,000 epinephrine; 2% Lidocaine 1:100,000 epinephrine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington- School of Dentistry

Seattle, Washington, 98112, United States

Location

Related 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.

  PMID: 24493972 BACKGROUND

• 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.

  PMID: 6387029 BACKGROUND

• 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.

  PMID: 24778680 BACKGROUND

• 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.

  PMID: 22794202 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Diseases; Pain, Postoperative

Interventions

Anesthetics, Local

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Limitations and Caveats

Limitations/future direction * Sample size * Lack of a control group: Inferior alveolar nerve block with saline solution * Lack of inclusion of other pre-operative pulpal diagnoses: Pulp Necrosis, Previously Initiated Therapy, Previously Treated * Lack of inclusion of maxillary posterior teeth * We could have tracked patients for longer periods of time to examine persistent pain

Results Point of Contact

• Title: Avina Paranjpe
• Organization: University of Washington

avina@uw.edu

206-543-5044

Study Officials

• Avina Paranjpe

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor: School of Dentistry

Model Details: Two different arms each receiving an inferior alveolar nerve block with two different local anesthetics

Study Record Dates

• First Submitted: June 19, 2021
• First Posted: April 21, 2022
• Study Start: September 29, 2021
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 29, 2025
• Results First Posted: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)