The Post-ICU Pain Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZealand University Hospital
About this trial
BACKGROUND: ICU survivors may experience serious psychological, physical and cognitive impairments following ICU admission, collectively termed Post Intensive Care Syndrome (PICS). Persistent pain is an underrecognized component of PICS. Previous research has shown that persistent pain is a profound clinical challenge in ICU survivors, however, research demonstrates conflicting results. Furthermore, no studies have examined the prevalence of persistent pain in ICU survivors in a contemporary Danish ICU setting.
OBJECTIVES: We aim to examine the clinical trajectory, risk factors, and pathophysiology of persistent pain in ICU survivors in Denmark.
DESIGN AND SAMPLE SIZE: The study is designed as a multicenter, prospective, inception cohort study with clinical follow-up. Based on the pre-study sample size calculation, 800 patients will be included. Patients will be contacted by telephone 90 days and 180 days after ICU discharge, and a series of questionnaires regarding pain, sleep quality, affective state and quality of life will be completed. A subgroup of patients will undergo a detailed clinical examination including quantitative sensory testing between 180-365 days after ICU discharge.
POPULATION: Patients will be recruited from 4 Danish ICU departments. Inclusion criteria include adult patients (18 years of age), acute admission to the ICU, and an ICU admission of a minimum of 48 hours.
OUTCOMES: The primary outcome is the prevalence of pain assessed by the Brief Pain Inventory (BPI) at 90 and 180 days after ICU discharge. Secondary outcomes include additional detailed descriptions of pain and daily activity, sleep quality, affective state, quality of life, treatment- and patient-related risk factors, and biomarkers associated with development of persistent pain.
Substudies:
\- QST substudy: 80 participants (40 with pain and 40 without pain) recruited from the main cohort will undergo Quantative Somatosensory Testing (QST). The objectives are first, to delineate somatosensory profiles of ICU survivors with and without pain, and second, to examine the presence of neuropathic pain in ICU survivors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult ICU patients ≥18 years of age
Acute admission to the ICU
ICU length of stay of at least 48 hours
Disqualifiers
Patients transferred from a non-participating ICU
Patients with pre-planned admission to the ICU e.g., following elective surgery
Patients unable to complete questionnaires, including those who are unable to understand or speak Danish, or patients with severe cognitive deficits.
Trial population
Patients admitted to the ICU
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Prevalence of pain
Patients are defined as having pain if they answer "yes" to question number 1 in the Brief Pain Inventory - Short Form
Time frame
180 day follow-upSecondary outcomes
1
Brief Pain Inventory - Short Form (BPI-SF)
Additional components of the Brief Pain Invenstory Short Form
Time frame
At follow-up at 90 and 180 days2
Incidence of new-onset persistent pain after ICU discharge
Definition of new-onset persistent pain: Individuals presenting with pain according to Brief Pain Inventory Short Form at 90 AND 180 days follow-up AND not suffering from persistent pain/using pain medication regularly before ICU admission, as reported by the individual.
Time frame
at 90 and 180 days follow-up3
Quality of life measured by EuroQol-5-domain 5-level (EQ-5D-5L)
The EQ-5D-5L comprises 5 components (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression) which can be rated at 5 levels. Furthermore, a Visual Analog Scale (VAS) documents self-rated health
Time frame
at 90 and 180 days4
The Single Item Sleep Quality Scale (SQS)
The respondent is asked to rate the overall quality of sleep over a 7-day recall period on a VAS. Respondents are instructed to consider the following components before answering the questionnaire: hours of sleep, night wakings, how easily they fall asleep, how often they wake earlier then needed, and how refreshed they feel when waking. Sleep quality is scored as follows: 0 = terrible, 1-3 = poor, 4-6 = fair, 7-9 = good, and 10 = excellent
Time frame
at 90 and 180 daysOther outcomes
1
The Short Physical Performance Battery (SPPB)
QST SUBSTUDY: This test includes a series of tasks designed to examine physical performance. The SPPB requires limited space and takes about 10 minutes to complete. It contains 3 domains (3 m gait speed, 5 times chair stands, and 3 progressive standing balance tasks). Each component is scored separately, and a total score is calculated. The maximum score is 12 indicating little to no mobility impairment
Time frame
between 180 days followup and 360 days.2
PainDETECT (PD-Q)
QST SUBSTUDY: The questionnaire assesses pain intensity (three questions), pain course patterns, the location of pain and presence of radiating pain (via a body chart), and sensory descriptors of pain (seven questions). Scores of 0-12 indicate neuropathic pain component is unlikely, scores of 12-18 indicates results are ambiguous, however a neuropathic component can pe present, and lastly scores of 19-38 indicates neuropathic pain component is likely
Time frame
between 180 days followup and 360 days3
QST outcomes
QST SUBSTUDY: \- simple reaction time (seconds)
Time frame
between 180 days followup and 360 days4
QST outcomes
QST SUBSTUDY: \- Thermal thresholds: Thresholds are determined by increasing the thermode temperature from baseline 32°C (ramp rate + 1.0 °C/s) until the subject activates the 'stop' button. WDT is defined as the point at which the patient first perceives a sensation of warmth. HPT is defined as the point at which the thermal sensation first turns into pain. The cut-off temperature is 50°C, avoiding the risk of thermal skin injuries
Time frame
between 180 days followup and 360 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Zealand University Hospital
Lead sponsor
Aalborg University Hospital
Collaborator
Source ClinicalTrials.gov