- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06555107
Acute Preoperative Pain and Chronic Post-surgical Pain in Emergency Surgery (POCSE)
Studies evaluating postoperative pain as a risk factor for CPSP are almost exclusively carried out in the context of scheduled surgery. As a result, the preoperative pain studied as a risk factor for chronicity is essentially a state of pain that has persisted for several weeks or even several months.
In emergency surgeries, patients are subject to acute preoperative pain of varying intensity and the duration of which may vary by a few days. A few studies have highlighted the intensity of acute preoperative pain as a factor favouring moderate to severe postoperative pain. At this point, no study has addressed the long-term consequences of this intense preoperative pain the emergency context.
An evaluation in the field of emergency surgery, where the preoperative pain is often intense and limited in time, would enable us to identify more precisely the impact of acute pain on the incidence of CPSP.
The investigators are hypothesising that the occurrence of CPSP at 3 months in patients undergoing emergency orthopaedic or abdominal surgery is associated with acute preoperative pain.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Paul TARPIN, Dr
- Phone Number: 0322087980
- Email: Tarpin.Paul@chu-amiens.fr
Study Locations
-
-
-
Amiens, France, 80054
- Recruiting
- CHU Amiens-Picardie
-
Contact:
- Paul TARPIN, MD
- Phone Number: 0322087980
- Email: Tarpin.Paul@chu-amiens.fr
-
Sub-Investigator:
- Ottilie Fumery, MD
-
Sub-Investigator:
- Stephane BAR, Pr
-
Sub-Investigator:
- Benjamin Mestan, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥18 years old.
- Emergency orthopaedic and/or abdominal surgery.
- Informed consent.
- Affiliation to a social security scheme
Exclusion Criteria:
- Intraoperative complications that are life-threatening or require the surgical procedure to be discontinued.
- Post-operative intensive care unit admission.
- Ambulatory surgery.
- Endoscopic surgery.
- Repeat surgery at the same site in less that 3months.
- Pregnant or breast-feeding patients.
- Patients under guardianship or deprived of liberty.
- Patients suffering from psychiatric pathologies.
- Patients suffering from neurodegenerative pathologies.
- Patients for whom self-assessment of pain using a numerical scale (0-10) cannot be carried out (non-communicative patients, non-French-speaking patients, and so on).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Frequency of CPSP
Time Frame: at 3 months
|
at 3 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Postoperative Complications
- Pathologic Processes
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Acute Pain
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Surveys and Questionnaires
Other Study ID Numbers
- PI2024_843_0038
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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