Persistent Opioid Consumption After Major Abdominal Surgery and Its Determinants
CompletedNCT05197465
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
Brief summary (from the registry)
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.
Study details
- Official title
- Persistent Opioid Consumption After Major Abdominal Surgery and Its Determinants: A Prospective Cohort Study
- Conditions
- Major Abdominal Surgery
- Chronic Pain
- Opioid Use
- Interventions
- Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Collaborators
- Maisonneuve-Rosemont Hospital
- Start date
- 2022-02-13
- Primary completion
- 2024-03-14
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Patients undergoing major open abdominal surgery during the study period (6 months) * Patients suffering from chronic pain or using opioids may be included since they are at risk of developing CPSP or POC Exclusion Criteria: * Patients who have already participated in the study will be excluded as well as patients who will undergo a second surgery after discharge from hospital and before the 90-day deadline for the primary endpoint. * Patients undergoing appendectomies, inguinal hernia repair and abdominal wall hernia repair other than incisional hernias.
Canadian sites (2)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05197465