Identification of Predictive Factors of Postoperative Pain After Oral Surgery From Phenotypic Parameters Easily Accessible Preoperatively
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Postoperative pain Day 1
研究概览
简要总结
This project aims to study various predictive factors of postoperative pain after oral surgery among different parameters accessible preoperatively, in order to build a predictive model. It also aims to validate the external consistency of the Pain Sensitivity Questionnaire in an odontological context.
详细描述
This project aims to study various predictive factors of postoperative pain after oral surgery among different phenotypic parameters accessible to preoperative interrogation (anxiety about dental care, personal perception of pain sensitivity, gender, eye color, hair color, blood group) in order to build a predictive model. It also aims to validate the external consistency of the Pain Sensitivity Questionnaire (PSQ) in an odontological context, by studying the relationship between the personal perception of pain sensitivity (measured by the PSQ) and anxiety about dental care (measured by the Corah Dental Anxiety Scale), as well as dramatization in the face of pain (measured by the Pain Catastrophizing Scale).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
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
- •Adult patient, male or female, eligible for dental extraction under local anesthesia,
- •either a tooth on the arch,
- •either wisdom tooth(s) (2 homolateral wisdom teeth (maxilla + mandibular) or a mandibular wisdom tooth).
- •Fluent in speaking and reading French.
- •Able to give informed consent to research.
- •Affiliation to a Social Security scheme.
排除标准
- •Pregnant or breastfeeding women.
- •Contraindication to paracetamol, NSAIDs, tramadol, or anesthetic agents local.
- •Patient uncooperative, unlikely or unable to comply with all procedures of the protocol.
- •Chronic use of opiates, in a therapeutic or illicit context.
- •Chronic depression on long-term antidepressants.
- •Stomatological pathology that may interfere with the conduct of the intervention or modify the results: insufficient mouth opening, pathologies of the temporal mandibular joints ...
- •Active medical pathology, or any medical condition judged by the investigator to be incompatible with the study.
- •Patient under guardianship, curatorship or safeguard of justice.
- •Refusal to participate.
研究组 & 干预措施
Open-label cohort, with short follow-up
This is a collection of data from postoperative questionnaires and simple, non-invasive clinical observations. The oral surgery acts in question are performed in daily practice without any change in patient management. The intraoperative data collected come from routine care. Postoperative data (pain and analgesic intake) are collected by self-questionnaires and no visit on purpose is required.
干预措施: Questionnaires (Other)
结局指标
主要结局
Postoperative pain Day 1
时间窗: Information gathering on the evening of day 1
The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"
Postoperative pain Day 2
时间窗: Information gathering on the evening of day 2
The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"
Postoperative pain Day 3
时间窗: Information gathering on the evening of day 3
The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"
Postoperative pain Day 4
时间窗: Information gathering on the evening of day 4
The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"
Postoperative pain Day 5
时间窗: Information gathering on the evening of day 5
The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"
次要结局
- Explanatory variable 1: Pain Sensitive Questionnaire(1 time only before surgery)
- Explanatory variable 2: Corah's Dental Anxiety Scale (CDAS)(1 time only before surgery)
- Explanatory variable 3: Pain Catastrophizing Scale (PCS)(1 time only before surgery)
- Explanatory variable 4: Gender(1 time only before surgery)
- Explanatory variable 5: Eye color(1 time only before surgery)
- Explanatory variable 6: Hair color(1 time only before surgery)
- Explanatory variable 7: Blood group(1 time only before surgery)