Persistent Opioid Consumption After Major Abdominal Surgery and Its Determinants (POCAS)

Persistent Opioid Consumption After Major Abdominal Surgery and Its Determinants: A Prospective Cohort Study

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 Overview

• Status: Active, not recruiting
• Conditions: Chronic Pain; Opioid Use; Major Abdominal Surgery
• Intervention / Treatment: Other: Questionnaires

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 700

Contacts and Locations

• Study Contact: Name: François Martin Carrier, MD, PhD; Phone Number: 12132 514-890-8000; Email: francois.martin.carrier@umontreal.ca
• Study Contact Backup: Name: Julie Desroches, PhD; Phone Number: 24542 514-890-8000; Email: anesthesie.recherche.chum@ssss.gouv.qc.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2X 3E4
      • Centre Hospitalier de l'Universite de Montreal (CHUM)
    • Montréal, Quebec, Canada, H1T 2M4
      • CIUSS-de-l'Est-de-l'Île-de-Montréal (Hôpital Maisonneuve-Rosemont)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Participants will complete pain and quality of life questionnaires. Opioid consumption will also be assessed using validated questionnaires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of chronic pain and its assessment by BPI	Presence of persistent pain in the 7 days prior to the interview or worsening of the pain at surgical site for patients who had pain at that site prior to surgery. Pain will be assessed using a modified version of the Brief Pain Inventory (BPI)-short questionnaire, which consists of questions regarding presence, duration and location of pain, pain-relief medication usage, pain intensity using Numeral Rating Scale (NRS), treatment effectiveness in percentage of pain relief ranging from 0 to 100% and impact of pain on quality of life also using NRS. NRS ranges from 0 to 10, 10 meaning the worst outcome.	3 months after surgery
Change in quality of life assessed by SF-12	Quality of life will be assessed at baseline and at 3 months following surgery using the Medical Outcomes Study Short Form Survey (SF-12) questionnaire, which results in 2 scores representing physical and mental health. Both mental and physical health scores range from 0 to 100, and a higher score means a better outcome. The results of the SF-12 completed at 3 months following surgery will be compared to the baseline results.	3 months after surgery

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborators: Maisonneuve-Rosemont Hospital
• Investigators: Principal Investigator: François Martin Carrier, MD, PhD, Centre Hospitalier de l'Universite de Montreal (CHUM)

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2022
• Primary Completion (Actual): March 11, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: January 5, 2022
• First Submitted That Met QC Criteria: January 5, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 21.314

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No