Persistent Opioid Consumption After Major Abdominal Surgery and Its Determinants

NCT05197465 | Completed

• 1 other identifier: 21.314
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Major Abdominal Surgery; Chronic Pain; Opioid Use

Outcome Measures

Primary Outcomes (1)

• Patient-reported opioid use

  Any consumption of opioids as declared by patients during the 7 days prior to the 3-month interview

  3 months after surgery

Secondary Outcomes (2)

• Presence of chronic pain and its assessment by BPI

  3 months after surgery

• Change in quality of life assessed by SF-12

  3 months after surgery

Study Arms (1)

Patients undergoing major abdominal surgery

The investigators aim to conduct a prospective observational, cohort study including all patients undergoing a major open abdominal surgery.

Other: Questionnaires

Interventions

Questionnaires OTHER

Participants will complete pain and quality of life questionnaires. Opioid consumption will also be assessed using validated questionnaires.

Patients undergoing major abdominal surgery

Eligibility Criteria

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

Study Population

The investigators aim to conduct a prospective cohort study. This study will take place at the Centre Hospitalier de l'Université de Montréal (CHUM) and CIUSSS de l'Est-de-l'Île-de-Montréal (Maisonneuve-Rosemont Hospital)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Maisonneuve-Rosemont Hospital: collaborator

Study Sites (2)

CIUSS-de-l'Est-de-l'Île-de-Montréal (Hôpital Maisonneuve-Rosemont)

Montreal, Quebec, H1T 2M4, Canada

Location

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• François Martin Carrier, MD, PhD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 19, 2022
• Study Start: February 13, 2022
• Primary Completion: March 14, 2024
• Study Completion: September 30, 2024
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)