Post-Surgical PainNCT04988490
Quantification of Cannabinoids and Comparison to Post-Surgical Pain Medication Requirements and Surgical Outcomes
An observational study of Post-Surgical Pain and Post-Surgical Complication, run by University of Colorado, Denver at 1 site in United States.
Trial summary
To determine how daily cannabis use affects surgical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Surgical Pain, Post-Surgical Complication, Cancer
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2021to 14 Jun 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: Cancer patients over the age of 18 undergoing inpatient abdominal surgery for the treatment of cancer who use cannabis daily prior to surgery or who are non-users of cannabis.
Who may be able to join
- Patients > 18 years old
- Undergoing abdominal surgery for the treatment of cancer
- Report no cannabis use in the last year or chronic cannabis use (defined as at least weekly use for 3 months or more)
Who cannot join
- patients with chronic pain, chronic pain syndrome on opioids
- female patients who are pregnant or lactating
- patients who report use of illicit substances
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Denver, Colorado, 80045
About this study
Official title: Quantification of Endo- and Phytocannabinoids With Comparison to Pain Medication Requirements and Surgical Outcomes for Patients Undergoing Abdominal Surgery for Cancer
To determine how daily cannabis use affects surgical outcomes.
Read the detailed description
To determine if patients who are daily cannabis users that are undergoing inpatient abdominal surgery for the treatment of cancer are different from non-cannabis users regarding phytocannabinoid and endocannabinoid levels, pain scores, pain medication requirements, and surgical complications.
- Conditions
- Post-Surgical Pain, Post-Surgical Complication, Cancer, Cannabis Use
- Keywords
- Cannabis, Post-Surgical Complications, Post-Surgical Pain, Abdominal Surgery
- Medical subject headings
- Pain, Postoperative, Neoplasms, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Daily cannabis users | Patients undergoing inpatient abdominal surgery for the treatment of cancer who self-report daily cannabis use | |
| Cannabis non-users | Patients undergoing inpatient abdominal surgery for the treatment of cancer who self-report no cannabis use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption
Postoperative opioid consumption among daily cannabis using and non-cannabis using patients undergoing abdominal surgery for cancer
Measured: 30 days
Correlation of postoperative opioid consumption
Correlation between serum phytocannabinoid and endocannabinoid levels, pain scores, and postoperative opioid consumption
Measured: 30 days
Correlation of postoperative complications
Correlation between 30-day post-operative complications, preoperative, and postoperative phytocannabinoid and endocannabinoid levels
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start11 Oct 2021
- Primary completion2 May 2024
- Study completion14 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Surgical PainStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Institute of Cannabis Research
- Responsible party
- Sponsor
- Investigators
- Ana Gleisner, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988490
- Sponsor's protocol ID
- 21-3544.cc
- Other IDs
- P30CA046934, NCI-2021-08865
- Status last verified
- Mar 2025
- First submitted
- 26 Jul 2021
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Endo- and Phytocannabinoids With Comparison to Pain Medication Requirements and Surgical Outcomes for Patients Undergoing Abdominal Surgery for Cancer
- ClinicalTrials.gov ID
- NCT04988490
- Acronym / sponsor ID
- 21-3544.cc
- Conditions
- Post-Surgical Pain, Post-Surgical Complication, Cancer, Cannabis Use
- Keywords
- Cannabis, Post-Surgical Complications, Post-Surgical Pain, Abdominal Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Institute of Cannabis Research
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 14 Jun 2024 (actual)
- First posted
- 3 Aug 2021 (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.
To determine how daily cannabis use affects surgical outcomes.
Detailed description
To determine if patients who are daily cannabis users that are undergoing inpatient abdominal surgery for the treatment of cancer are different from non-cannabis users regarding phytocannabinoid and endocannabinoid levels, pain scores, pain medication requirements, and surgical complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily cannabis users | – | –Patients undergoing inpatient abdominal surgery for the treatment of cancer who self-report daily cannabis use |
| Cannabis non-users | – | –Patients undergoing inpatient abdominal surgery for the treatment of cancer who self-report no cannabis use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients over the age of 18 undergoing inpatient abdominal surgery for the treatment of cancer who use cannabis daily prior to surgery or who are non-users of cannabis.
Key inclusion criteria (3 listed)
- Patients > 18 years old
- Undergoing abdominal surgery for the treatment of cancer
- Report no cannabis use in the last year or chronic cannabis use (defined as at least weekly use for 3 months or more)
Key exclusion criteria (3 listed)
- patients with chronic pain, chronic pain syndrome on opioids
- female patients who are pregnant or lactating
- patients who report use of illicit substances
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative opioid consumption
Time frame: 30 days
Postoperative opioid consumption among daily cannabis using and non-cannabis using patients undergoing abdominal surgery for cancer
Correlation of postoperative opioid consumption
Time frame: 30 days
Correlation between serum phytocannabinoid and endocannabinoid levels, pain scores, and postoperative opioid consumption
Correlation of postoperative complications
Time frame: 30 days
Correlation between 30-day post-operative complications, preoperative, and postoperative phytocannabinoid and endocannabinoid levels
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 10 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Ana Gleisner principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Surgical Pain and Post-Surgical Complication, run by University of Colorado, Denver at 1 site in United States.
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 3 inclusion and 3 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 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Postoperative opioid consumption (time frame: 30 days). The study lists 3 primary outcomes in all. 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 10 Mar 2025.