Trial Outcomes & Findings for Effect of Post-Operative Anesthetics on Post-Operative Pain in Patients Receiving Endodontic Treatment (NCT NCT05338671)

NCT ID: NCT05338671

Last Updated: 2025-05-29

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 35 participants
• Primary outcome timeframe: Patients will be asked to track pain levels at 6 post-operatively on a visual analog scale
• Results posted on: 2025-05-29

Participant Flow

Participant milestones

Measure	2% Lidocaine 1:100,000 Epinephrine 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. Local anesthetic: Patients will receive inferior alveolar nerve block injection following endodontic treatment.	0.5% Bupivicaine 1:200,000 Epinephrine 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. Local anesthetic: Patients will receive inferior alveolar nerve block injection following endodontic treatment.
Overall Study STARTED	18	17
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	2% Lidocaine 1:100,000 Epinephrine 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. Local anesthetic: Patients will receive inferior alveolar nerve block injection following endodontic treatment.	0.5% Bupivicaine 1:200,000 Epinephrine 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. Local anesthetic: Patients will receive inferior alveolar nerve block injection following endodontic treatment.
Overall Study Lost to Follow-up	2	2
Overall Study Root canal completed in a single visit	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	2% Lidocaine 1:100,000 Epinephrine n=15 Participants 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. Local anesthetic: Patients will receive inferior alveolar nerve block injection following endodontic treatment.	0.5% Bupivicaine 1:200,000 Epinephrine n=15 Participants 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. Local anesthetic: Patients will receive inferior alveolar nerve block injection following endodontic treatment.	Total n=30 Participants Total of all reporting groups
Age, Continuous	39.2 years STANDARD_DEVIATION 12.1 • n=15 Participants	37.2 years STANDARD_DEVIATION 17.2 • n=15 Participants	38.2 years STANDARD_DEVIATION 14.6 • n=30 Participants
Sex: Female, Male Female	10 Participants n=15 Participants	8 Participants n=15 Participants	18 Participants n=30 Participants
Sex: Female, Male Male	5 Participants n=15 Participants	7 Participants n=15 Participants	12 Participants n=30 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Patients will be asked to track pain levels at 6 post-operatively 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.

Outcome measures

Measure	2% Lidocaine 1:100,000 Epinephrine n=15 Participants 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. Local anesthetic: Patients will receive inferior alveolar nerve block injection following endodontic treatment.	0.5% Bupivicaine 1:200,000 Epinephrine n=15 Participants 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. Local anesthetic: Patients will receive inferior alveolar nerve block injection following endodontic treatment.
Post-operative Pain Level 6 Hours on a Visual Analog Scale	64.2 units on a scale Standard Deviation 43.9	43.1 units on a scale Standard Deviation 43.1

PRIMARY outcome

Timeframe: Patients will be asked to track pain level at 12 hours post-operatively 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.

Outcome measures

Measure	2% Lidocaine 1:100,000 Epinephrine n=15 Participants 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. Local anesthetic: Patients will receive inferior alveolar nerve block injection following endodontic treatment.	0.5% Bupivicaine 1:200,000 Epinephrine n=15 Participants 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. Local anesthetic: Patients will receive inferior alveolar nerve block injection following endodontic treatment.
Post-operative Pain Level 12 Hours on a Visual Analog Scale	67.4 units on a scale Standard Deviation 44.9	45.1 units on a scale Standard Deviation 34.5

PRIMARY outcome

Timeframe: Patients will be asked to track pain level at 24 hours post-operatively 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.

Outcome measures

Measure	2% Lidocaine 1:100,000 Epinephrine n=15 Participants 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. Local anesthetic: Patients will receive inferior alveolar nerve block injection following endodontic treatment.	0.5% Bupivicaine 1:200,000 Epinephrine n=15 Participants 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. Local anesthetic: Patients will receive inferior alveolar nerve block injection following endodontic treatment.
Post-operative Pain Level 24 Hours on a Visual Analog Scale	48.9 units on a scale Standard Deviation 27.9	36.5 units on a scale Standard Deviation 32.5

PRIMARY outcome

Timeframe: Patients will be asked to track pain level at 48 hours post-operatively 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.

Outcome measures

Measure	2% Lidocaine 1:100,000 Epinephrine n=15 Participants 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. Local anesthetic: Patients will receive inferior alveolar nerve block injection following endodontic treatment.	0.5% Bupivicaine 1:200,000 Epinephrine n=15 Participants 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. Local anesthetic: Patients will receive inferior alveolar nerve block injection following endodontic treatment.
Post-operative Pain Level 48 Hours on a Visual Analog Scale	45.3 units on a scale Standard Deviation 34.1	30.1 units on a scale Standard Deviation 34.2

PRIMARY outcome

Timeframe: Patients will be asked to track pain level at 72 hours post-operatively 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.

Outcome measures

Measure	2% Lidocaine 1:100,000 Epinephrine n=15 Participants 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. Local anesthetic: Patients will receive inferior alveolar nerve block injection following endodontic treatment.	0.5% Bupivicaine 1:200,000 Epinephrine n=15 Participants 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. Local anesthetic: Patients will receive inferior alveolar nerve block injection following endodontic treatment.
Post-operative Pain Level 72 Hours on a Visual Analog Scale	35.5 units on a scale Standard Deviation 41.6	21.9 units on a scale Standard Deviation 26.7

Adverse Events

2% Lidocaine 1:100,000 Epinephrine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

0.5% Bupivicaine 1:200,000 Epinephrine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Avina Paranjpe

University of Washington

Phone: 206-543-5044

Email: avina@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place