NCT06655454

Supplemental Postoperative Bupivacaine Following Non-Surgical Endodontic Treatment

The Effects of Supplemental Postoperative 0.5% Bupivacaine With 1:200,000 Epinephrine Following Non-Surgical Endodontic Treatment on Patients' Quality of Life, Pain, and Analgesic Consumption

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: New York University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will investigate the impact of an additional injection of long-acting anesthetic on pain level, quality of life, and use of pain medication after a nonsurgical endodontic treatment. The long-acting anesthetic will be compared to a mock injection group and a group with no additional anesthetic to determine any differences in effects.

Detailed description

The study will investigate the impact of postoperative supplemental long-acting bupivacaine on patient's pain, quality of life, and analgesic use following treatment for symptomatic irreversible pulpitis on patients with pre-operative pain levels of 5 or above (on a 0-10 analog scale). Bupivacaine will be compared to a placebo/mock injection and no injection to determine the difference in effect.

Conditions

• Pain Assessment
• Quality of Life (QOL)
• Analgesic Use

Interventions

Type	Name	Description
DRUG	Supplemental Postoperative Bupivacaine	This is the intervention of interest. A supplemental injection of bupivacaine will be given postoperatively to patients who are assigned this intervention.
DRUG	Placebo Injection	This intervention will appear to give patients an additional injection, but no additional drug will be given.

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2024-10-23
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study