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
Organization
University of WashingtonProduct
Local anestheticIndication
Endodontic DiseaseIndication
Postoperative PainIndication
Irreversible Pulpitis