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

Pain, Postoperative Clinical Trial

— PHEDOPO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05405088
• Other study ID #: RBHP 2021 DEVOIZE 2
• Secondary ID: 2021-A02885-36
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: February 2022
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: +33473754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 73
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety, Dental
• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Explanatory variable 4: Gender	Gender will be determined between male or female subject	1 time only before surgery
Secondary	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
Secondary	Explanatory variable 6: Hair color	Hair color will be determined by color: Black Brown Blond Red	1 time only before surgery
Secondary	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