Chronic Pain After Surgical Intensive Care Admission: Incidence and Risk Factors: the DOLOCHROREA Study (DOLOCHROREA)

August 1, 2017 updated by: Guillaume BESCH, Centre Hospitalier Universitaire de Besancon

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25030
        • Centre Hospitalier Universitaire de Besançon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of chronic pain
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of anxiety and depression
Time Frame: 6 months
The incidence of anxiety and depression at 6 months after the end of the stay in our intensive care unit will be assessed by using a validated french version of the Hospital Anxiety and Depression (HAD) scale during a phone call.
6 months
Incidence of neuropathic pain
Time Frame: 6 months
The incidence of neuropathic pain at 6 months after the end of the stay in our intensive care unit will assessed by using the DN4 tool during a phone call.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Guillaume Besch, M.D., Centre Hospitalier Universitaire de Besançon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

September 3, 2015

First Submitted That Met QC Criteria

September 3, 2015

First Posted (Estimate)

September 4, 2015

Study Record Updates

Last Update Posted (Actual)

August 2, 2017

Last Update Submitted That Met QC Criteria

August 1, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15/03

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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