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Evaluation of Pain Trajectories After Surgery and Their Potential Relationship With Chronicity at 3 Months

Evaluation of Pain Trajectories After Surgery and Their Potential Relationship With Chronicity at 3 Months: a Single-center Prospective Cohort Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05326737
Acronym
ETADOL
Enrollment
5000
Registered
2022-04-14
Start date
2021-02-23
Completion date
2024-05-23
Last updated
2022-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Pain, Surgical Procedures, Operative

Keywords

pain trajectory

Brief summary

The effective management of acute postoperative pain remains a daily challenge despite the organizational efforts made and the techniques put in place. Thirty percent of patients who undergo surgery suffer from chronic post-surgical pain, of which 5 to 10% are of severe intensity. Many preoperative, intraoperative, and postoperative factors, related to the patient, the surgical procedure, or the anesthetic technique, have been incriminated as risk factors for chronic post-surgical pain. The severity of acute postoperative pain is recognized as one of the risk factors for the occurrence of chronic post-surgical pain on which we can hope to interact during the peri-operative period. In this cohort study, we wish to define the typologies of postoperative pain trajectories observed from Day 0 to Day 7 and to estimate the proportion of patients with an abnormal resolution of pain in a model of organization such as that of our institution, in classic hospitalization and in ambulatory care.

Interventions

Patients will evaluate their pain levels via a verbal numerical scale on days 1(or-1), 2, 3, 4, 5, 6 & 7.

Patients are required to fill out the PCS questionnaire between on day -1 or +1.

OTHERTelephone contact at 3 months

Patients will be contacted at 3 months post-surgery for pain questionnaires DN4 and EQ5D5L.

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* The patient must be insured or beneficiary of a health insurance plan * The patient is available for 3 months of follow-up * The patient has undergone a planned surgical procedure in one of the participating departments * The patient is willing and able to respond to the study questionnaires

Exclusion criteria

* The patient is participating in another study * The patient is in an exclusion period determined by a previous study * The patient is under judicial protection, under tutorship or curatorship * It is impossible to correctly inform the patient * Patient admitted to the ICU and still intubated at day 1

Design outcomes

Primary

MeasureTime frameDescription
The pain trajectory for the first 7 post-operative days.Day 7The pain trajectory is the change in pain level evaluated by verbal numerical pain (from 0 to 10) from day 0 (surgery) to day 7.

Secondary

MeasureTime frameDescription
The EuroQuol EQ5D5L questionnairemonth 3The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Since the surgery, do you have persistent pain? yes/nomonth 3Since the surgery, do you have persistent pain? yes/no
Verbal numerical scale for pain (ranging from 0 to 10)month 3Verbal numerical scale for pain (ranging from 0 to 10)
The DN4 questionnairemonth 3The Douleur Neuropathique 4 (DN4) questionnaire was developed by the French Neuropathic Pain Group and is a simple and objective tool, with the ability to distinguish nociceptive from neuropathic pain
Pain Catastrophizing Scale (PCS)day -1 or day +1The Pain Catastrophizing Scale (PCS) is a 13-item self-report measure designed to assess catastrophic thinking related to pain among adults with or without chronic pain.
Cumulative consumption of antalgic drugsday -1 or day +1Cumulative consumption of antalgic drugs
Have you had complications from your surgery? yes/nomonth 3Have you had complications from your surgery? yes/no

Countries

France

Contacts

Primary ContactJoël L'Hermite, MD
joel.lhermite@chu-nimes.fr+33.(0)4.66.68.36.18

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026