Quantification of Cannabinoids and Comparison to Post-Surgical Pain Medication Requirements and Surgical Outcomes

March 6, 2025 updated by: University of Colorado, Denver

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80045
        • University of Colorado Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • patients with chronic pain, chronic pain syndrome on opioids
  • female patients who are pregnant or lactating
  • patients who report use of illicit substances

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative opioid consumption
Time Frame: 30 days
Postoperative opioid consumption among daily cannabis using and non-cannabis using patients undergoing abdominal surgery for cancer
30 days
Correlation of postoperative opioid consumption
Time Frame: 30 days
Correlation between serum phytocannabinoid and endocannabinoid levels, pain scores, and postoperative opioid consumption
30 days
Correlation of postoperative complications
Time Frame: 30 days
Correlation between 30-day post-operative complications, preoperative, and postoperative phytocannabinoid and endocannabinoid levels
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Cancer Institute (NCI)
Institute of Cannabis Research

Investigators

  • Principal Investigator: Ana Gleisner, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2021

Primary Completion (Actual)

May 2, 2024

Study Completion (Actual)

June 14, 2024

Study Registration Dates

First Submitted

July 26, 2021

First Submitted That Met QC Criteria

July 26, 2021

First Posted (Actual)

August 3, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-3544.cc
  • P30CA046934 (U.S. NIH Grant/Contract)
  • NCI-2021-08865 (Other Identifier: CTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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