Chronic Pain in COVID-19 Patients Discharged From Intensive Care Unit

NCT04940208 | Completed DMC

• 1 other identifier: 2020-A02929-30
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 3

Brief Summary

More than six million French were affected by SARS-COV2 epidemic. About 20% of infected peoples were hospitalized, and about 5% were admitted to the intensive care units (ICU) for severe SARS-COV2 acute respiratory distress syndrome (ARDS) management. A spectrum of neuropsychiatric sequelae, specific for the ICU exposure, was already described, including post-intensive care syndrome and persistent pain. A growing body of evidence suggests the impact of SARS-COV2 exposure on the occurrence of neurological disorders and chronic pain syndrome development in COVID-19 patients. Taking together, one can expect a large number of patients discharged from ICU after severe COVID-19 with high prevalence of persistent pain and psychological disorders. To date, no study has evaluated neither the incidence of persistant pains in ICU COVID-19 survivors, nor pain phenotypes. The knowledge of such data is crucial in order to anticipate the management of such patients by specialized pain team, and to quantify the possible incurred burden of care. Our study aims to evaluate the incidence of pain, pain localization and severity, associated pain-related psychological disorders, and to perform quantitative sensory testing in severe COVID-19 patients, admitted to the ICU for more than 48 hours and successfully discharged home during the first French pandemic wave.

Conditions

COVID-19 Pandemic; ICU; Pain, Chronic; Post Intensive Care Unit Syndrome; Neuropathic Pain

Keywords

SARS-COV2; Intensive care unit; critical illness survivors; chronic pain; COVID long; Neuropathic pain; Quantitative Sensory testing

Outcome Measures

Primary Outcomes (1)

• Incidence of secondary chronic pain

  Secondary chronic pain as defined by International Classification of Disease -11th revision (ICD-11). Chronic secondary pain is organized into the following six categories: 1. Chronic cancer-related pain (ICD-11 code MG30.1) 2. Chronic postsurgical or post-traumatic pain (ICD-11 code MG30.2) 3. Chronic secondary musculoskeletal pain (ICD-11 code MG30.3) 4. Chronic secondary visceral pain (ICD-11 code MG30.4) 5. Chronic neuropathic pain (ICD-11 code MG30.5) 6. Chronic secondary headache or orofacial pain (ICD-11 code MG30.6) Any pain detected in the population of interest and fitting in one of 6 categories will be accounted.

  starting 6 month after discharge

Secondary Outcomes (12)

• Frequency of different secondary chronic pain classes

  starting 6 month after discharge

• Pain sensitivity level

  starting 6 month after discharge

• Pain localization

  starting 6 month after discharge

• The severity of pain and its impact on functioning

  starting 6 month after discharge

• Neuropathic pain

  starting 6 month after discharge

Study Arms (1)

post COVID-19 ICU survivors

Patients hospitalized to the ICU in the context of severe COVID-19 and discharged alive during the first French COVID-19 pandemic wave

Other: Pain and neuropsychological questionnaires; Diagnostic Test: Quantitative Sensory testing

Interventions

Pain and neuropsychological questionnaires OTHER

Patient-reported outcomes, listed in the Secondary Outcome Measure Section

post COVID-19 ICU survivors

Quantitative Sensory testing DIAGNOSTIC_TEST

Summation pain threshold test and Heat pain threshold skin test

post COVID-19 ICU survivors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients, infected with SARS COV2 and developed severe COVID, requiring hospitalisation to the ICU during the first French wave of COVID 19, with length of stay \> 48 hours, survived and successfully discharged, and approached from 6th month post discharge.

You may qualify if:

• adults (\>=18 y.o.)
• hospitalized in the ICU for at least 48 hours
• with SARS-Cov2 infection confirmed by Polymerase Chain Reaction (PCR)/serology and/or a suggestive chest Computed Tomography scan
• during the first wave of COVID 19 from March to December 2020 at three investigator sites (2 in Paris and 1 in Lyon)
• discharged alive from the ICU
• at least 6 months after discharge

You may not qualify if:

• patient refusal
• inability to communicate or to have in-person appointment
• death in the period from ICU discharge to the first phone call for interview

Sponsors & Collaborators

• Mikhail Dziadzko, MD, PhD: lead
• Hôpital Raymond Poincaré: collaborator
• Bicetre Hospital: collaborator

Study Sites (3)

Hôpital Raymond Poincare - AP-HP

Garches, Hauts-de-Seine, 92380, France

Location

Hôpital Bicêtre AP-HP

Le Kremlin-Bicêtre, Le Kremlin-Bicêtre, France

Location

Hopital de la Croix Rousse - Hospices Civils de Lyon

Lyon, 69004, France

Location

Related Publications (5)

• Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.

  PMID: 32644129 BACKGROUND

• Needham EJ, Chou SH, Coles AJ, Menon DK. Neurological Implications of COVID-19 Infections. Neurocrit Care. 2020 Jun;32(3):667-671. doi: 10.1007/s12028-020-00978-4.

  PMID: 32346843 BACKGROUND

• Asadi-Pooya AA, Simani L. Central nervous system manifestations of COVID-19: A systematic review. J Neurol Sci. 2020 Jun 15;413:116832. doi: 10.1016/j.jns.2020.116832. Epub 2020 Apr 11.

  PMID: 32299017 BACKGROUND

• Lee AM, Wong JG, McAlonan GM, Cheung V, Cheung C, Sham PC, Chu CM, Wong PC, Tsang KW, Chua SE. Stress and psychological distress among SARS survivors 1 year after the outbreak. Can J Psychiatry. 2007 Apr;52(4):233-40. doi: 10.1177/070674370705200405.

  PMID: 17500304 BACKGROUND

• Martinez V, Dziadzko M, Tamayo J, Schitter S, Guichard L, Richeux F, Roggerone S, Branche P, Schlaefflin L, Nacto Y, Antunes T, Negre I, Annane D, Aubrun F. Chronic pain characteristics in COVID-19 survivors after an ICU stay. A cross-sectional study. Anaesth Crit Care Pain Med. 2023 Dec;42(6):101267. doi: 10.1016/j.accpm.2023.101267. Epub 2023 Jun 24.

  PMID: 37356618 DERIVED

MeSH Terms

Conditions

COVID-19; Chronic Pain; Neuralgia; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Pain Physician

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 25, 2021
• Study Start: January 11, 2021
• Primary Completion: January 1, 2022
• Study Completion: February 1, 2022
• Last Updated: February 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)