NCT06903624

Brief Summary

Postoperative pain management is critical for surgical recovery, affecting patient outcomes, hospitalization duration, and quality of life. Variability in pain perception and medication needs among surgical patients poses a challenge in clinical practice. Identifying predictive factors for pain severity and analgesic use could enhance personalized pain management strategies. Cannabis, containing cannabinoids with analgesic and anti-inflammatory properties, has garnered attention as a potential pain management option for surgical patients. The effectiveness of cannabis varies, depending on surgery type, severity, and individual pain tolerance. Some studies suggest cannabis users may experience heightened pain sensitivity and require more analgesics, while others highlight its potential to reduce opioid use. Despite growing interest, the use of cannabis in surgery remains controversial due to a lack of large-scale clinical trials evaluating its safety and efficacy in this setting. Some research indicates cannabis use could lower pain levels post-surgery and reduce opioid needs. However, other studies raise safety concerns, and conflicting findings have yet to establish its role conclusively. Given these uncertainties, healthcare professionals must carefully monitor cannabis use in surgical patients. Patients should inform providers of any cannabis use before surgery to ensure appropriate pain management and minimize risks. This study aims to analyze pain intensity and analgesic usage patterns across various surgeries using real-world medical data. Machine learning models will predict high analgesic needs, focusing on cannabis users. This research seeks to optimize postoperative pain treatment and personalize clinical strategies.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2025

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 31, 2025

Completed
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

9.2 years

First QC Date

March 24, 2025

Last Update Submit

March 31, 2025

Conditions

Keywords

CannabisPostoperative painAnalgesicsOpioids

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity

    To assess the impact of cannabis use on postoperative pain intensity (measured using the To assess the impact of cannabis use on postoperative pain intensity (measured using the Visual Analog Scale, VAS in a scale from 0 -no pain- to 10 -worst pain possible-)

    7 days

Secondary Outcomes (1)

  • Analgesic Consumption

    7 days

Study Arms (2)

Non cannabis users

Patients that underwent surgical procedures

Chronic cannabis users

Patients that use cannabis due to medical conditions causing chronic pain and underwent surgical procedure.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients that underwent painfull surgical procedures will be cosidered in the study.

You may qualify if:

  • Patients aged 18 and over.
  • Patients who underwent surgery under general anesthesia.

You may not qualify if:

  • Minimally painful surgical procedures, including wrist and ankle tendon surgeries, minor rectal surgeries (e.g., fistula repair, rectal polyp removal), and minor gynecological procedures (e.g., vaginal procedures, transvaginal tape \[TVT\] insertion and transurethral procedures).
  • Surgeries associated with potential neurological complications, such as craniotomy.
  • Procedures involving percutaneous stent placement, including ureteral stent insertion.
  • Incomplete pain assessment records
  • Patients with severe cognitive impairments, affecting their ability to accurately report pain levels.
  • Patients unable to express VAS scale.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, PostoperativeMarijuana Abuse

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medicine Doctor

Study Record Dates

First Submitted

March 24, 2025

First Posted

March 31, 2025

Study Start

January 1, 2016

Primary Completion

February 25, 2025

Study Completion

March 24, 2025

Last Updated

April 3, 2025

Record last verified: 2025-03