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

NCT04207411 | Unknown Phase 2

• 2 other identifiers: RBHP 2018 MELIN (BADDAP)2018-002825-49
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Keywords

Persistent dentoalveolar pain; bupivacaine; lidocaine; clinical trial; randomization

Outcome Measures

Primary Outcomes (1)

• Proportion of patients (with persistent dentoalveolar pain). with at least 30% pain reduction

  Mean numerical scale on journal of pain (last 7 days)

  difference compared to the basal value at day 0 (visit 1) to value at Month 2 (visit 6)

Secondary Outcomes (3)

• Brief Pain Inventory

  The questionnaire will be completed at day-7, and month 2 for all patients and then "month 3 and month 6" for patient of experimental group or visit month 4, month 5, month 8 for control group.

• Patient's Global Impression of Change (PGIC)

  The questionnaire will be completed at month 2 for all patients and then "month 3 and month 6" for patient of experimental group or visit month 4, month 5, month 8 for control group.

• Neuropathic Pain Assessment Questionnaire (QEDN)

  The questionnaire will be completed at day-7, and month 2 for all patients and then "month 3 and month 6" for patient of experimental group or visit month 4, month 5, month 8 for control group.

Study Arms (2)

Bupivacaine

EXPERIMENTAL

The dose received at each injection will be 5 mg. One injection per week will be carried out over 4 consecutive weeks

Drug: Bupivacaine

Lidocaine

SHAM COMPARATOR

The dose received at each injection will be 1.25mg. An injection unique per week will be carried out over 4 consecutive weeks.

Drug: Bupivacaine; Drug: Lidocaine

Interventions

Bupivacaine DRUG

Injection of anesthetics blocks once a week during 4 weeks.

Bupivacaine; Lidocaine

Lidocaine DRUG

Injection of anesthetics blocks once a week during 4 weeks.

Lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient, male or female, over 18, with persistent dentoalveolar pain defined according to the criteria:
• daily presence (\> 2 hours / day and for more than 3 months) and continues pain;
• located at one or more teeth or at the level of the alveolar bone;
• not following a nervous path;
• clinical, radiological and neurological examinations showing no cause organic visible;
• dental causes excluded by appropriate tests;
• local or systemic pathologies related to pain apart.
• Pain intensity greater than or equal to 4/10 on numerical scale
• Patient informed of the constraints of the study and having given his written consent. Benefiting of a social security scheme.
• Mastering correctly French.

You may not qualify if:

• Pregnant women, breastfeeding, or likely to be pregnant.
• Oral pain of known origin (cancerous, infectious, traumatic).
• Patient having modified (stopped, started or modified dosage) in the last 2 month local or systemic medication that may interfere with the study results (for example, patients taking long-range psychotropic drugs will not be excluded).
• All medical pathology judged by the investigator as not compatible with the study.
• Known hypersensitivity to local amide-bound anesthetics or to any of the excipients
• Treatment anticoagulant or known disorder of blood
• Porphyria.
• Atrioventricular conduction requiring training permanent electrosystol not yet realized.
• Epilepsy not controlled by a treatment.
• Patient non-cooperating, not speaking or not reading fluently French or in the impossibility of understanding the principle of a pain scale or understanding the study or to sign an informed consent.
• Patient under guardianship, curatorship, or deprived of liberties.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Bupivacaine; Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides

Study Officials

• Céline Melin, BDS, PhD

  CHU de Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre, Pharm D

CONTACT

04 73 75 11 95; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The dentist will prepare the product in another room, so the patient will not know the type of product used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: bupivacaine or lidocaine randomized treatment.

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 20, 2019
• Study Start: August 25, 2020
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2023
• Last Updated: August 31, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)