Major Abdominal SurgeryPOCASNCT05197465
Persistent Opioid Consumption After Major Abdominal Surgery and Its Determinants
An observational study of Major Abdominal Surgery and Chronic Pain, run by Centre hospitalier de l'Université de Montréal (CHUM) at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Abdominal Surgery, Chronic Pain, Opioid Use
- What is being tested?
- Questionnaires
- How many people
- 700 participants
- Where
- 2 sitesCanada
- Study dates
- 13 Feb 2022to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
CIUSS-de-l'Est-de-l'Île-de-Montréal (Hôpital Maisonneuve-Rosemont)
Montreal, Quebec, H1T 2M4
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4
About this study
Official title: 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).
Read more
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.
Read the 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:
- 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,
- Certain surgical and individual risk factors are determinants of POC,
- The reduction of acute pain with neuraxial analgesia will help reduce the prevalence of postoperative POC.
- 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.
- Conditions
- Major Abdominal Surgery, Chronic Pain, Opioid Use
- Being tested
- Questionnaires
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Participants will complete pain and quality of life questionnaires. Opioid consumption will also be assessed using validated questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing major abdominal surgery | The investigators aim to conduct a prospective observational, cohort study including all patients undergoing a major open abdominal surgery. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported opioid use
Any consumption of opioids as declared by patients during the 7 days prior to the 3-month interview
Measured: 3 months after surgery
Secondary outcomes (2)
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.
Measured: 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.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start13 Feb 2022
- Primary completion14 Mar 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Abdominal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Collaborators
- Maisonneuve-Rosemont Hospital
- Responsible party
- Sponsor
- Investigators
- François Martin Carrier, MD, PhD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197465
- Sponsor's protocol ID
- 21.314
- Acronym
- POCAS
- Status last verified
- Feb 2025
- First submitted
- 5 Jan 2022
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistent Opioid Consumption After Major Abdominal Surgery and Its Determinants: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05197465
- Acronym / sponsor ID
- POCAS / 21.314
- Conditions
- Major Abdominal Surgery, Chronic Pain, Opioid Use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Maisonneuve-Rosemont Hospital
- Study start
- 13 Feb 2022 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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,
- Certain surgical and individual risk factors are determinants of POC,
- The reduction of acute pain with neuraxial analgesia will help reduce the prevalence of postoperative POC.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing major abdominal surgery | – | Other: QuestionnairesThe investigators aim to conduct a prospective observational, cohort study including all patients undergoing a major open abdominal surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesParticipants will complete pain and quality of life questionnaires. Opioid consumption will also be assessed using validated questionnaires. | Other | Patients undergoing major abdominal surgery |
Primary outcome
Patient-reported opioid use
Time frame: 3 months after surgery
Any consumption of opioids as declared by patients during the 7 days prior to the 3-month interview
2 secondary outcomes
Presence of chronic pain and its assessment by BPI
Time frame: 3 months after surgery
Change in quality of life assessed by SF-12
Time frame: 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Martin Carrier, MD, PhD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Abdominal Surgery and Chronic Pain, run by Centre hospitalier de l'Université de Montréal (CHUM) at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported opioid use (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.