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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Anxiety, Dental
• Intervention / Treatment: Other: Questionnaires

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Anticipated): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • CHU de Clermont-Ferrand
    • Principal Investigator: Laurent Devoize

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

Other: Questionnaires; Pain Sensitive Questionnaire (PSQ) Corah's Dental Anxiety Scale (CDAS) Pain Catastrophizing Scale (PCS) Gender Eye color Hair color Blood group

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Laurent Devoize, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: April 5, 2022
• First Submitted That Met QC Criteria: June 2, 2022
• First Posted (Actual): June 6, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Pain; Postoperative; Gender; Oral surgery; Eye color; Blood group; Hair color
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: RBHP 2021 DEVOIZE 2; 2021-A02885-36 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No