Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05197465 |
| Other study ID # |
21.314 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 13, 2022 |
| Est. completion date |
September 30, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Centre hospitalier de l'Université de Montréal (CHUM) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The opioid crisis is a growing problem around the world, with prescription opioids being a
major contributor to this crisis. They can be prescribed in different chronic and acute
settings, such as surgery. This is therefore an event which may mark a first exposure to
opioids in many opioid-naive patients and be associated with subsequent long-term use. This
long-term persistent opioid consumption (POC) after surgery may be due, among other things,
to chronic postsurgical pain (CPSP). Many risk factors have been identified in the
development of chronic pain. Some are related to the surgery while others are related to
patient characteristics. Of these, preoperative opioid use, pre-existing pain, and
psychological history are major factors that increase the risk of POC or CPSP.
The population having undergone major abdominal surgery remains poorly represented in studies
of postoperative POC. It can be reasonable to think that these patients may have a similar
high risk of CPSP and POC as other surgical patients. The potential harmful effects of POC
and CPSP may limit the recovery of these patients and impair their quality of life (QoL).
The risk factors for CPSP are important to consider when considering POC. While psychological
factors related to pain have been shown to be associated with postoperative pain and
analgesic use, the association between unrelieved postoperative pain and POC may have been
underestimated. Regional anesthesia is frequently used in major abdominal surgery to reduce
the risk of acute and chronic postoperative pain. However, data regarding CPSP specifically
after major abdominal surgery are lacking, and the role of neuraxial analgesia on its
prevention and on postoperative opioid use is unclear.
Since little is known about the prevalence of POC after major abdominal surgery and its
determinants, the investigators propose to conduct a major abdominal surgery cohort study by
examining POC and CPSP using information reported by patients.
Description:
Objectives
Primary objective: estimate the prevalence of POC 3 months after major abdominal surgery,
describe its distribution in both opioid-naive and chronic opioid users and across different
types of abdominal surgery, and estimate its association with persistent pain and quality of
life.
Secondary objective: estimate the effects of individual potential risk factors on POC after
major abdominal surgery.
Tertiary exploratory objective: evaluate the effect of neuraxial analgesia on POC.
Exploratory objectives: describe distribution of opioid misuse among patients with POC and
the opioid consumption trajectory among preoperative chronic opioid users.
The hypotheses of the study are that:
1. POC will be high after abdominal surgeries (close to what has been reported in thoracic
surgeries and pancreatectomies) and will be associated with a higher prevalence of
persistent pain and lower quality of life,
2. Certain surgical and individual risk factors are determinants of POC,
3. The reduction of acute pain with neuraxial analgesia will help reduce the prevalence of
postoperative POC.
4. Opioid misuse will be rare among patients with POC and most preoperative chronic opioid
users with POC will not have decreased their consumption.
Design of the study: multicenter, prospective, cohort study. After obtaining consent,
consecutive adult patients undergoing major open abdominal surgery will be included over a
6-month period.
Before surgery, data on planned surgery, demographics, socio-economic status, surgical and
medical history, including information on preoperative opioid use and preoperative pain will
be collected. For chronic opioid users, information about the reasons for opioid consumption
will be recorded. Presence of co-morbidities, frailty, anxiety or depressive symptoms,
catastrophizing tendency, and quality of life will be assessed using validated
questionnaires.
During the hospitalization associated with the index surgery, the following data will be
collected: type of anesthesia, administration of opioids or any other analgesic medication,
care required following the intervention, quality of pain control, dosage of opioid
consumption and presence of an opioid prescription upon discharge from hospital. The need to
perform any other surgery during index hospitalization and the use of the pain transition
service will be noted.
Patients will be contacted by phone three months after surgery. To quantify opioid use, a
Timeline Follow Back questionnaire will be used. This questionnaire will include questions
regarding opioids used, dose, frequency of use, mode of administration, reason for use, and
presence of other sources of opioids, if applicable (family, unused opioids from old
prescriptions). For preoperative opioid users, changes in opioid consumption will be
assessed. Pharmacy-reported information regarding served opioid will be collected. The
presence of complications related to opioid consumption as well as the risk of misuse will be
assessed by using the Opioid Compliance Checklist. Information on hospitalizations associated
with opioid-related events and on care level trajectory for up to three months after surgery
will be recorded. Postoperative pain and quality of life will be assessed using validated
questionnaires.
