Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04164342 |
| Other study ID # |
2019-A01865-52 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 27, 2019 |
| Est. completion date |
July 26, 2022 |
Study information
| Verified date |
July 2022 |
| Source |
University Hospital, Angers |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The objective of this observational, prospective study is to evaluate the incidence of
chronic pain at 3 months after ICU discharge in patients with a prolonged ICU stay (i.e. ≥3
days).
Investigators will assess the proportion of patients with chronic pain (defined according to
the Brief Pain Inventory questionnaire), by interview at 3 months after ICU discharge.
All data potentially associated with chronic pain will be collected, including the type of
surgery, the acute pain (intensity and duration) during the ICU stay, the type and dose of
opioids received, patients comorbidity...
Patients will be follow-up at 6 and 12 months to identify impact on quality of life.
Description:
Acute pain is common for ICU patients, with an incidence of 33% at rest and of 56% during
nursing care. However, there is few if any data on chronic pain after an ICU stay (ie lasting
more than 3 months after ICU discharge), while chronic pain seems to be frequent in patients,
in particular following surgeries. Indeed, several studies have shown that in postoperative
period, many patients suffer from chronic pains, with incidence from 12 to more than 50 %,
depending on surgery.
Known risk factors include:
- Female gender
- young age
- mental disorder antecedent
- pain prior to surgery
- type of anesthesia, including the type and dose of opioids used
- not correctly controlled severe pain
- prolonged pain
Chronic pain is becoming a public health problem, because of its impact on patients quality
of life, but also on the over consumption of opioids as a result, and the addiction that
arise.
Chronic pain following an ICU stay as been studied so far. Available studies in ICU are
mainly interested in the quality of life, which remains altered even many years after ICU
discharge. The most popular survey is the SF-36 which includes a section on chronic pain.
However no study, to the best of our knowledge, were interested in chronic pain prevalence
and in its risk factors after an ICU stay.
In our surgical ICU unit, there is two sedation-analgesia protocols, that use different types
of opioids (ie sufentanyl or Remifentanyl), in addition physicians may prescribe morphine for
awake patients or other oral opioids. The impact of opioid choice on chronic pain prevalence
after ICU discharge is not known today, but could be important, as it is for postoperative
chronic pain.
We hypothesis that chronic pain is frequent after a surgical ICU stay and that some factors
may be associated with it, including the type of opioids received.
The investigators will conduct a prospective observational study to evaluate this prevalence
and the risk factors associated with chronic pain following a prolonged ICU stay.
Patients with an ICU stay ≥3 days, capable to answer to questionnaires will be eligible and
will be invited to participate to the study just before their discharge from ICU.
After inclusion, patient's conditions prior to ICU stay, type od admission, all critical care
events, pain (duration and intensity), treatments (including opioids)... will be collected.
Investigators will pass the Brief Pain Inventory (BPI) questionnaire A to the patients before
discharge from ICU.
Investigators will phone the patient at 3 (primary endpoint), 6 and 12 months after ICU
discharge, in order to fill BPI questionnaire for chronic pain diagnosis, to evaluate its
impact on quality of life, to fill PHQ 2 survey and record all pain treatment. Beside those 3
phone calls, there is no change in patient care, but patients can be offered to consult their
doctor in case of chronic pain screening or presence of depressive symptoms.
This study will allow to characterise chronic pain incidence after an hospitalisation period
of at least 3 days in surgical ICU, and to better define possible risk factors. Some risk
factors of chronic pain could be modifiable, in particular the type of opioid received.
Identification of risk factors for chronic pain could help identifying patients who could
benefit from specific care or from post-ICU follow-up consultations.
