Investigating Cannabis Use Parameters on Anesthesia and Inflammation in Lumbar Spinal Surgeries

NCT07354412 | Enrolling By Invitation

• 1 other identifier: 2128606
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 2

Brief Summary

Cannabis is the most commonly used illicit drug in the United States with reported rates of use increasing from approximately 50 million in 2020 to 61.8 million in 2023 among individuals aged 12 or older. This rise can be attributed to a combination of growing social acceptance and expanding legalization for recreational and medical use of cannabis. Consequently, this has led to increased commercially available cannabis products with heterogeneous concentrations of cannabinoids (i.e., THC:CBD ratios) and new methods of administration becoming more available (e.g., vaping and gummies). Taken together, this rapidly shifting landscape further contributes to the significant variability in individual use patterns (i.e., frequency, duration, and route of administration) resulting in diverse clinical responses, which poses significant challenges for anesthetic management. Recent systematic reviews and meta-analysis have quantitatively demonstrated that cannabis users require higher dosages during anesthesia induction, experience greater hemodynamic instability, and report higher opioid consumption and pain scores post-operatively. These findings have led to the prevailing notion that cannabis exposure adversely affect anesthetic management. Yet, key cannabis exposure parameters in individual use patterns (i.e., variations in THC:CBD ratios, route of administration, frequency, and duration of use) remain poorly characterized and could confound observed clinical effects in relation to their effects on pain modulation and anesthetic requirements. Current perioperative assessments do not account for these critical variables, creating a gap that limits the development of more accurate and personalized anesthetic protocols. Failure to account for individual cannabis exposure parameters may lead to inappropriate anesthetic dosing - where underdosing could result in intraoperative awareness, pain, or patient movement, while overdosing might cause cardiovascular depression, respiratory failure, or prolonged recovery from anesthesia. Concomitantly, researchers have discovered that cannabis consumption modulates immune function such that early life exposure to cannabis produces a long-lasting and persistent inflammatory state characterized by reduced serum levels of IL-6, TNF-α, and IL-2. In contrast, recent research demonstrates that cannabinoid exposure improves skin healing in patients with cutaneous disorders. However, the effects of altered inflammatory responses, and the diverse actions of various cannabinoids on postoperative wound healing remain largely unexplored. Our long-term goal is to elucidate the mechanistic impact of chronic cannabis use parameters on anesthetic and analgesic requirements, thereby enabling the development of personalized, evidence-based perioperative management strategies. The investigators hypothesize that chronic cannabis exposure leads to impaired endogenous pain and immune modulation, resulting in increased intraoperative anesthetic dosing, heightened hemodynamic variability, and elevated postoperative pain and inflammation.

Conditions

Cannabis Use

Keywords

cannabis; anesthesia; inflammation; cytokines

Outcome Measures

Primary Outcomes (5)

• Intraoperative Propofol dose (mg/kg/hr)

  Our primary outcome is intraoperative anesthetic dose (i.e., propofol mg/kg/hr), which will be extracted from anesthesia records and entered into each patient's individual REDCap record by the study personnel.

  Duration of surgery

• Change in serum inflammatory biomarker IL-2 (pg/mL)

  The investigators will measure serum biomarker of inflammation IL-2 (pg/mL) before and after surgery, and again at 2- and 6-week follow-ups, to assess how cannabis exposure modulates immune responses.

  From enrollment to 6 week post-surgery

• Change in serum inflammatory biomarker IL-6 (pg/mL)

  The investigators will measure serum biomarker of inflammation IL-6 (pg/mL) before and after surgery, and again at 2- and 6-week follow-ups, to assess how cannabis exposure modulates immune responses.

  From enrollment to 6 week post-surgery

• Change in serum inflammatory biomarker TNF-α (pg/mL)

  The investigators will measure serum biomarker of inflammation TNF-α (pg/mL) before and after surgery, and again at 2- and 6-week follow-ups, to assess how cannabis exposure modulates immune responses.

  From enrollment to 6 week post-surgery

• Change in serum inflammatory biomarker CRP (pg/mL)

  The investigators will measure serum biomarker of inflammation CRP (pg/mL) before and after surgery, and again at 2- and 6-week follow-ups, to assess how cannabis exposure modulates immune responses.

  From enrollment to 6 week post-surgery

Secondary Outcomes (11)

• Intraoperative opioid dose (MME)

  Duration of surgery

• Wound healing (cm^2)

  From end of surgery to 6 week post-surgery

• Postoperative pain scores (0-10)

  Post-operative day 0

• Mean arterial pressure (MAP) variability minutes

  Duration of surgery

• Heart rate (HR) variability in minutes

  During surgery

Study Arms (3)

Never users

Patients who have never used cannabis products

Current users

Individuals who have used cannabis products in the last 30 days

Past users

Individuals who have used cannabis products in the past but not in the last 30 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ambulatory and short-stay lumbar spine surgery patients

You may qualify if:

• Undergoing ambulatory or short-stay lumbar spine surgery.
• English speaking.
• Ability to consent for themselves.
• Aged 18 years and above.
• Access to a smartphone or computer/laptop (to be determined on the day of consent).
• Any lifetime use of cannabis products irrespective of the strain, CBD/THC content, or frequency of use.

You may not qualify if:

• Non-English speaking.
• Inability to consent for themselves.
• Actively pregnant (SOC) or planning to become pregnant in the next 2 months (research only). Urine testing will be done as SOC prior to undergoing surgery.
• Active or past severe psychiatric instability (e.g., active psychosis, acute suicidality)
• Active, uncontrolled use of illicit drugs use such as methamphetamine, cocaine, opioids, etc., as listed in their clinical charts.
• History of major neurological illnesses.
• Presence of an untreated illness or serious medical condition.
• Any other concern that in the investigator's opinion would impact participant safety, study instruction compliance, or confound the interpretation of the study results.
• No access to a smartphone or computer/laptop.

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (2)

Missouri Orthopaedic Institute

Columbia, Missouri, 65211, United States

Location

University Hospital

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Marijuana Abuse; Inflammation

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Antoinette Burger, PhD

  University of Missouri-Columbia

  STUDY DIRECTOR

• Randi Foraker, PhD

  University of Missouri-Columbia

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: January 21, 2026
• Study Start: December 11, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)