Epidemiology of Chronic Pain as Part of the Post-intensive Care Syndrome

Chronic Pain Clinical Trial

— ALGO-REA  

Official title:

Epidemiology of Chronic Pain as Part of Post-resuscitation Syndrome. Multicenter Prospective Non-interventional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04817696
• Other study ID #: RC21_0020
• Status: Completed
• Start date: April 25, 2021
• Est. completion date: January 25, 2022

Study information

• Verified date: February 2022
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Post-intensive care syndrome is an entity of cognitive, physical and mental health disorders occurring and persisting after ICU discharge and responsible of disabilities and decrease of quality of life. Nowadays mental and cognitive health impairments appear to be well known but few data are available about chronic pain after a critical care illness. The aim of the study is to determine the incidence and the risks factors of chronic pain after ICU.

Description:

Post-intensive care syndrome is receiving growing interest because of the chronic health issues secondary to a critical care admission: neurocognitive impairment, motor sequelae, mood disturbances. These chronic health issues bear tremendous burden for patients and next-of-kin. Among these chronic health issues, chronic pain symptoms could have major consequences on the patient's quality of life. In the local single-center follow-up experience, 6 months after a patient's admission in the critical care unit, around 20% of patients displayed chronic pain symptoms. The investigators have addressed these patients to pain care specialists, with successful treatment success. However, the evaluation of pain symptoms remains simplistic; moreover, the incidence of chronic pain symptoms in patients after critical care unit admission, receives little attention in the literature although these symptoms may literally blunt out all other health issues. The incidence and type of chronic pain symptoms has been poorly described, to the best of knowledge.

The aim of this study is to perform a multi-center nationwide epidemiologic study of chronic pain symptoms after a critical care unit admission. The investigators intend to describe the incidence of chronic pain assessed with a Simple Verbal Score ≥ 3, 3 months after the ICU admission. The investigators also intend to describe the incidence of painful symptoms, at ICU discharge as well as the type of pain symptoms (ie neuropathic pain) at discharge and at 3 months using the ID-Pain scale. The evaluation at 3 months will be performed during a physical follow-up or self-assessed by the patient. The investigators intend to explore the risk factors associated with chronic pain, as an exploratory analysis.

The investigators are performing a nation-wide multicentric study. At this point 24 centers are participating to this study and the investigators expect to include 700 patients with a 3 months follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1079
• Est. completion date: January 25, 2022
• Est. primary completion date: January 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria :

• All patients admitted in ICU

• ICU length-of-stay = 48 hours

• No major cognitive impairment that could prevent pain evaluation

Exclusion Criteria :

• Patient under 18-year-old

• Patient under guardianship

• Patient unable to communicate or quantify pain with a Verbal Score and ID-Pain score

• Refusal to participate

Related Conditions & MeSH terms

• Chronic Pain
• Critical Care

Intervention

Other:
• Patients without chronic pain symptoms
Verbal score < 3 at 3 months
• Patients with chronic pain symptoms
Verbal score = 3 at 3 months

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of pain (Simple Verbal Scale =3) persisting at 3 months after ICU admission	Chronic pain is defined as a Simple Verbal Scale (ranging from 0 - no symptoms- to 10 - worst symptoms imaginable-) = 3.	3 months after the ICU admission
Secondary	Intensity of pain, and risk factors associated with pain at 3 months after ICU admission	The incidence of pain defined as a Simple Verbal Scale (ranging from 0 - no symptoms- to 10 - worst symptoms imaginable-) = 3	ICU discharge (median 7 days)
Secondary	Type of pain (ie neuropathic)	The Type of pain will be assessed with the score ID-Pain at ICU discharge, and 3 months after discharge. The ID-Pain is a 6-item scores that characterizes pain.The score ranges from 0 to 5. A score of 2-3 is predictive of a probable neuropathic pain and a score of 4-5 is highly associated with a neuropathic pain. Pain assessment tools require an auto-evaluation, performed by the patient	ICU discharge (median 7 days) and at 3 months after admission
Secondary	Pain management and risk factors in the ICU (Use of Remifentanyl)	Binary information (yes/no)	Median 7 days
Secondary	Pain management and risk factors in the ICU (Use of continuous intra-venous Morphine)	Binary information (yes/no)	Median 7 days
Secondary	Pain management and risk factors in the ICU (Use of continuous intra-venous Ketamine)	Binary information (yes/no).	Median 7 days
Secondary	Pain management and risk factors in the ICU (Use of anti-hyperalgesia medication (ie : anti-epileptique drugs, gabapentine, tricyclic anti-depressive drugs))	Binary information (yes/no).	Median 7 days
Secondary	Pain management and risk factors in the ICU (Use of locoregional anesthesia)	Binary information (yes/no).	Median 7 days
Secondary	Pain management and risk factors in the ICU (Type surgery and invasive procedures during ICU: Neurosurgery, orthopedic surgery spine surgery, abdominal surgery, thoracic surgery, thoracic drain)	Binary information (yes/no)	Median 7 days
Secondary	Pain management and risk factors in the ICU	• These outcomes and measures will be analyzed separately in the regression multivariable models of chronic pain and neuropathic pain.	Median 7 days
Secondary	Demographic data	Age; Sex; SAPS II; Type of ICU admission; Chronic Cardiovascular diseases: ischemic cardiomyopathy, hypertention; Chronic use of pain killers	Baseline
Secondary	General ICU data (Length of invasive mechanical ventilation)	Measured as the number of days between succesfull weaning of mechanical ventilation and initiation. Median duration : 7 days	ICU discharge (median 7 days)
Secondary	General ICU data	• ARDS. Defined as a PaO2/FiO2 ratio < 300mmHg, according to the Berlin definition (JAMA 2012). Binary information (yes/no). Median duration of monitoring : 7 days	ICU discharge (median 7 days)
Secondary	General ICU data ( Use of prone positionning during invasive mechanical ventilation)	Binary information (yes/no). Median duration of monitoring :7 days	ICU discharge (median 7 days)