Clinical trial

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

Name
STUDY00013406
Description
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.
Trial arms
Trial start
2021-09-29
Estimated PCD
2024-05-01
Trial end
2024-05-01
Status
Recruiting
Phase
Early phase I
Treatment
Local anesthetic
Patients will receive inferior alveolar nerve block injection following endodontic treatment.
Arms:
0.5% bupivicaine 1:200,000 epinephrine, 2% Lidocaine 1:100,000 epinephrine
Size
40
Primary endpoint
Post-operative pain level 6 hours on a visual analog scale
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
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
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
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
Patients will be asked to track pain level at 72 hours post-operatively on a visual analog scale
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two different arms each receiving an inferior alveolar nerve block with two different local anesthetics', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2024-02-13

1 organization

1 product

3 indications