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

Pain, Chronic Clinical Trial

— DOLOCHROREA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02541851
• Other study ID #: 15/03
• Status: Terminated
• Phase: N/A
• First received: September 3, 2015
• Last updated: August 1, 2017
• Start date: February 2015
• Est. completion date: September 2016

Study information

• Verified date: August 2017
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Intensive Care, Surgical
• Pain, Chronic

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of anxiety and depression	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
Secondary	Incidence of neuropathic pain	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