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NCT04988490 Clinical Trial

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

Cancer Clinical Trial

Official title:
Quantification of Endo- and Phytocannabinoids With Comparison to Pain Medication Requirements and Surgical Outcomes for Patients Undergoing Abdominal Surgery for Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04988490
Other study ID # 21-3544.cc
Secondary ID P30CA046934
Status Recruiting
Phase
First received
Last updated
Start date September 22, 2021
Est. completion date February 2025

Study information
Verified date November 2023
Source University of Colorado, Denver
Contact Camille Stewart
Phone 2566941233
Email camille.stewart@cuanschutz.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To determine how daily cannabis use affects surgical outcomes.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date February 2025
Est. primary completion date May 18, 2024
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria: - Patients > 21 years old - Undergoing abdominal surgery for the treatment of cancer - Report no cannabis use in the last year or daily cannabis use 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Colorado Research Center Denver Colorado

Sponsors (2)
Lead Sponsor Collaborator
University of Colorado, Denver National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

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