Efficacy of Repeated Locoregional Anesthetics Blocks With Bupivacaine in Patients Suffering of Chronic Dentoalveolar Pain. (BADDAP)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Proportion of patients (with persistent dentoalveolar pain). with at least 30% pain reduction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The dentist will prepare the product in another room, so the patient will not know the type of product used.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Bupivacaine
The dose received at each injection will be 5 mg. One injection per week will be carried out over 4 consecutive weeks
干预措施: Bupivacaine (Drug)
Lidocaine
The dose received at each injection will be 1.25mg. An injection unique per week will be carried out over 4 consecutive weeks.
干预措施: Bupivacaine (Drug)
Lidocaine
The dose received at each injection will be 1.25mg. An injection unique per week will be carried out over 4 consecutive weeks.
干预措施: Lidocaine (Drug)
结局指标
主要结局
Proportion of patients (with persistent dentoalveolar pain). with at least 30% pain reduction
时间窗: difference compared to the basal value at day 0 (visit 1) to value at Month 2 (visit 6)
Mean numerical scale on journal of pain (last 7 days)
次要结局
- 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.)