Identification of Predictive Factors of Postoperative Pain After Oral Surgery From Phenotypic Parameters Easily Accessible Preoperatively (PHEDOPO)

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Identification of Predictive Factors of Postoperative Pain After Oral Surgery From Phenotypic Parameters Easily Accessible Preoperatively

Conditions
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Pain, Postoperative, Anxiety, Dental

Intervention / Treatment
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* Other: Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Open-label cohort, with short follow-up<br>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. | Other: Questionnaires<br>* Pain Sensitive Questionnaire (PSQ) Corah's Dental Anxiety Scale (CDAS) Pain Catastrophizing Scale (PCS) Gender Eye color Hair color Blood group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain 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 | Information gathering on the morning of day 1 | 
| Postoperative pain 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 | Information gathering on the evening of day 1 | 
| Postoperative pain 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 | Information gathering on the morning of day 2 | 
| Postoperative pain 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 | Information gathering on the evening of day 2 | 
| Postoperative pain 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 | Information gathering on the morning of day 3 | 
| Postoperative pain 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 | Information gathering on the evening of day 3 | 
| Postoperative pain 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 | Information gathering on the morning of day 4 | 
| Postoperative pain 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 | Information gathering on the evening of day 4 | 
| Postoperative pain 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 | Information gathering on the morning of day 5 | 
| Postoperative pain 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 | Information gathering on the evening of day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Explanatory variable 1: Pain Sensitive Questionnaire | The Pain Sensitivity Questionnaire (PSQ) is a self-administered questionnaire comprising 17 items, each rated from 0 to 10. items n° 3-6-7-10-11-12-14 evoke moderately painful situations (and their sum makes it possible to calculate a minor PSQ score), and items n° 1-2-4-8- 15-16-17 evoke clearly painful situations (and their sum makes it possible to calculate a moderate PSQ score). The sum of these two scores is the total PSQ score. As each response to each item ranges from 0 to 10, the minimum value for all scores is 0, and the maximal ones for the minor, the moderate and the total PSQ scores are respectively 7, 7 and 14. The higher the scores, the higher the sensitivity to pain. | 1 time only before surgery | 
| Explanatory variable 2: Corah's Dental Anxiety Scale (CDAS) | Corah's Dental Anxiety Scale is based on 4 main questions and calculates a score from 5 to 20 (0-8: no anxiety; 9-12: moderate anxiety; 13-14: high anxiety; 15-20: severe anxiety) | 1 time only before surgery | 
| Explanatory variable 3: Pain Catastrophizing Scale (PCS) | Pain Catastrophizing Scale is based on 13 questions that cover 3 representative domains of dramatization: exaggeration of the pain felt (magnification), the tendency to constantly meditate on the pain (rumination) and the feeling of abandonment or lack of associated support (helplessness). As each response to each of the 13 responses items ranges from 0 to 4, the minimum value for the PCS score is 0, and the maximal is 52. The higher the score, the higher the level of pain catastrophizing. | 1 time only before surgery | 
| Explanatory variable 4: Gender | Gender will be determined between male or female subject | 1 time only before surgery | 
| Explanatory variable 5: Eye color | The color of the iris will be determined by the scale of Martine and Schultz: Light tones: 1-2: Blue 3: Blue gray 4: Gray 5: Blue-gray with yellow/brown spots 6: Grey-green with yellow/brown spots 7: Green 8: Green with yellow/brown spots 9-10-11: Light brown or hazelnut brown Dark tones: 12-13: Brown 14-15: Dark brown to black | 1 time only before surgery | 
| Explanatory variable 6: Hair color | Hair color will be determined by color: Black Brown Blond Red | 1 time only before surgery | 
| Explanatory variable 7: Blood group | The blood group will be determined by the groups: O HAS B AB as well as Rhesus + or - | 1 time only before surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Oral surgery, Postoperative, Gender, Eye color, Blood group, Hair color