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

NCT04988490 | Completed DMC

• 3 other identifiers: 21-3544.ccP30CA046934NCI-2021-08865
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

To determine how daily cannabis use affects surgical outcomes.

Conditions

Post-Surgical Pain; Post-Surgical Complication; Cancer; Cannabis Use

Keywords

Cannabis; Post-Surgical Complications; Post-Surgical Pain; Abdominal Surgery

Outcome Measures

Primary Outcomes (3)

• Postoperative opioid consumption

  Postoperative opioid consumption among daily cannabis using and non-cannabis using patients undergoing abdominal surgery for cancer

  30 days

• Correlation of postoperative opioid consumption

  Correlation between serum phytocannabinoid and endocannabinoid levels, pain scores, and postoperative opioid consumption

  30 days

• Correlation of postoperative complications

  Correlation between 30-day post-operative complications, preoperative, and postoperative phytocannabinoid and endocannabinoid levels

  30 days

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Cancer Institute (NCI): collaborator
• Institute of Cannabis Research: collaborator

Study Sites (1)

University of Colorado Hospital

Denver, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Neoplasms; Marijuana Abuse

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Ana Gleisner

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 3, 2021
• Study Start: October 11, 2021
• Primary Completion: May 2, 2024
• Study Completion: June 14, 2024
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

US (1)