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Completed

NCT Number: NCT02599233

Characterization of Post-operative Pain Trajectories Over Seven Days and Links With Chronicity

The main objective of this study is to establish the postoperative "pain pathways" observed from D1 to D7 in the context of the current management after orthopedic, digestive, obstetrics and gynecology, urology, neurosurgery, vascular and thoracicn surgeries.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

About this study

The secondary objectives of this study are:

A. To assess the incidence of Post-Surgical Chronic Pain (PSCP) Chronic 3 months post intervention.

B. To asses the incidence of neuropathic type pain (DN4 Questionnaire) at 3 months post intervention.

C. To study the potential links between pain trajectories and the presence or absence of PSCP.

D. To study the potential links between the presence or absence of PSCP and known risk factors for PSCP (patient-related data, data on the surgery, anesthesia data).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 (HADS, PCS, EN, DN4)

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

Treatment and study plan

Telephone conctact at 3 months

Other

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

In hospital pain evaluation

Other

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

In hospital questionnaires

Other

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

Primary outcomes

  1. The pain trajectory for the first 7 post-operative days.

    Time frame: Day 7 post-surgery

    The pain trajectory is the vector of 7 verbal numerical pain estimates (from 0 to 10) taken over 7 days (days 1 (or -1), 2, 3, 4, 5, 6 & 7).

    Day 0 is the day of surgery.

Secondary outcomes

  1. The DN4 questionnaire

    Time frame: month 3

  2. Since the surgery, do you have persistent pain? yes/no

    Time frame: month 3

  3. Is it the same pain before the surgery? yes/no

    Time frame: month 3

  4. Verbal numberical scale for pain (ranging from 0 to 10)

    Time frame: month 3

  5. Have you had complications from your surgery? yes/no

    Time frame: month 3

  6. Hospital Anxiety and Depression Scale (HADS)

    Time frame: day -1 or day +1

  7. Pain Catastrophizing Scale (PCS)

    Time frame: day -1 or day +1

  8. Cumulative consumption of antalgic drugs

    Time frame: day -1 or day +1

  9. Cumulative consumption of antalgic drugs

    Time frame: day 2

  10. Cumulative consumption of antalgic drugs

    Time frame: day 3

  11. Cumulative consumption of antalgic drugs

    Time frame: day 4

  12. Cumulative consumption of antalgic drugs

    Time frame: day 5

  13. Cumulative consumption of antalgic drugs

    Time frame: day 6

  14. Cumulative consumption of antalgic drugs

    Time frame: day 7

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Characterization of Post-operative Pain Trajectories Over Seven Days and Their Potential Links With Chronicity After 3 Months: a Single-center, Prospective, Pilot Cohort Study at the Nîmes University Hospital

Acronym: PATCH

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 6, 2015
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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