Efficacy of Repeated Locoregional Anesthetics Blocks With Bupivacaine in Patients Suffering of Chronic Dentoalveolar Pain. — BADDAP  

Pain Clinical Trial

Official title: Efficacy of Repeated Locoregional Anesthetics Blocks With Bupivacaine in Patients Suffering of Chronic Dentoalveolar Pain. (BADDAP)

Status Recruiting

Clinical Trial Summary

The aim of this study is to evaluate the efficacy of anesthetic blocks repeated with bupivacaine in the management of patients with persistent dentoalveolar pain. Goals are to improve the understanding of the physiopathological mechanisms of persistent dentoalveolar pain and to highlight predictive criteria for the effectiveness of anesthetic blocks.

Clinical Trial Description

This is a proof of concept, randomized, controlled prospective pharmacological trial, single blind, with two parallel arms.

The main objective of the study is to evaluate the efficacy of repeated locoregional anesthetic blocks with bupivacaine in patient's persistent dentoalveolar pain compared to a control group receives a simulated anesthesia (local anesthesia with lidocaine).

The secondary objectives are :

• to evaluate the tolerance of repeated locoregional anesthetic blocks to bupivacaine patients with persistent dentoalveolar pain compared to control receiving simulated anesthesia (local anesthesia with lidocaine).

• to evaluate demographic and nosological predictive factors (age of symptoms, Quantitative Sensory Testing results) and psychometric (anxiety, depression, dramatization) of the effectiveness of anesthetic blocks.

After signing the informed consent, the patients participate will be randomized to anesthetic block treatment with bupivacaine or lidocaine.

During the 1st step of the study patients will participate at 6 visits (day -7, day 0, day 7, day 14, day 21 and M2) and will receive either a series of 4 locoregional anesthetic blocks with bupivacaine or a series of 4 local anesthesia with lidocaine ("simulated" control group) at day 0, day 7, day 14 and day 21. The main criterion is raised 2 months after the end of the series.

During the 2nd step

• The patients from experimental group will be followed until month 6 (2 visits: month 3 month 6).

• The patients from control group :

• will received in open (if they want) a series of 4 locoregional anesthetic blocks with bupivacaine (day56, day,63, day 70, day 77) and will be followed during 6 months after the first injection (7 visits: day 63, day 70, day 77, month 3, month 4, month 5, month 8)

• will be followed until month 6 ((2 visits: month 3 month 6). ;

Related Conditions & MeSH terms

• Pain
• Stress, Psychological

• NCT number: NCT04207411
• Study type: Interventional
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre, Pharm D
• Phone: 04 73 75 11 95
• Email: promo_interne_drci@chu-clermontferrand.fr
• Status: Recruiting
• Phase: Phase 2
• Start date: August 25, 2020
• Completion date: October 2023