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

NCT05405088 | Completed

• 2 other identifiers: RBHP 2021 DEVOIZE 22021-A02885-36
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Postoperative; Anxiety, Dental

Keywords

Pain; Oral surgery; Postoperative; Gender; Eye color; Blood group; Hair color

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (7)

• 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

Study Arms (1)

Open-label cohort, with short follow-up

OTHER

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

Interventions

Questionnaires OTHER

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

Open-label cohort, with short follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Pain, Postoperative; Anxiety Disorders; Pain; Coitus

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Mental Disorders; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Laurent Devoize

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: June 6, 2022
• Study Start: July 1, 2022
• Primary Completion: June 26, 2024
• Study Completion: June 26, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

FR (1)