NCT02541851

Brief Summary

The acute pain remains unfortunately a major health problem in intensive care patients. Several factors, such as cancer, traumatic injuries, surgery, scars, diagnostic or therapeutic procedure, could contribute to an increase in the incidence or in the intensity of acute pain. The acute pain could impact on the prognosis of intensive care patients and on the patients perception of the quality of care. Moreover, the acute pain could lead to a long-term chronic pain syndrome. The chronic pain after intensive care admission could threaten the physical and psychological recovery after the stay in the intensive care unit (ICU). If many studies have been conducted to improve the management of the acute pain in the ICU, only few data exist on the incidence and the risk factors of the chronic pain after a stay in a surgical intensive care. The aim of the DOLOCHROREA study is to assess the incidence and the risk factors of 6-month chronic pain after a stay in our surgical ICU.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

August 2, 2017

Status Verified

August 1, 2017

Enrollment Period

1.6 years

First QC Date

September 3, 2015

Last Update Submit

August 1, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of chronic pain

    Pain is defined by The International Association for the Study of Pain (IASP) as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage". Pain exceeding the average period of healing of 2 to 3 months and ceasing to serve any apparent protective function is defined as chronic pain. The incidence of chronic pain will be assessed by using a validated french version of the Brief Pain Inventory during a phone call at 6 month after the end of the stay in our intensive care unit.

    6 months

Secondary Outcomes (2)

  • Incidence of anxiety and depression

    6 months

  • Incidence of neuropathic pain

    6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted in the surgical critical care unit of the Centre Hospitalier Universitaire de Besançon, France.

You may qualify if:

  • Admission in the surgical critical care unit of the University Hospital of Besançon from February 2015
  • Age over 18 yr old
  • Informed consent

You may not qualify if:

  • Age under 18 yr old
  • Death within the first 6 months after the end of the stay in the surgical intensive unit of the University Hospital of Besançon
  • Glasgow Coma Score under 8 at admission and/or at discharge
  • Planned admission after elective surgery
  • Medical history of cognitive disorder
  • Refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Besançon

Besançon, 25030, France

Location

Related Publications (1)

  • Battle CE, Lovett S, Hutchings H. Chronic pain in survivors of critical illness: a retrospective analysis of incidence and risk factors. Crit Care. 2013 May 29;17(3):R101. doi: 10.1186/cc12746.

    PMID: 23718685BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Guillaume Besch, M.D.

    Centre Hospitalier Universitaire de Besançon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

September 3, 2015

First Posted

September 4, 2015

Study Start

February 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

August 2, 2017

Record last verified: 2017-08

Locations