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

January 14, 2026 updated by: Pias Malaker, University of Missouri-Columbia
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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. To test this hypothesis, the investigators propose the following specific aims: Specific aim 1: Assess cannabis use parameters of individual use patterns in relation to anesthetic and analgesic requirements during elective spine surgeries. The investigators will conduct a prospective study in patients undergoing ambulatory or short-stay lumbar spine surgery asking them to fill out a survey detailing their individual cannabis use patterns (e.g., frequency, duration, and method of use) and attach pictures of their products (to obtain variations in THC:CBD ratios and product type). The investigators will compare intraoperative anesthetic dosing (e.g., propofol and opioid anesthetics) and evaluate hemodynamic parameters (e.g., blood pressure fluctuations and vasopressor requirements), and assess postoperative pain intensity and analgesic needs between cannabis users and non-users. This aim will provide direct clinical evidence linking specific chronic cannabis exposure parameters to intraoperative anesthetic and analgesic requirements, thereby laying the groundwork for tailored anesthetic protocols to reduce complications during surgery. Specific aim 2: Determine the inflammatory mechanisms by which chronic cannabis use alters pain processing and wound repair. The investigators will measure serum biomarkers of inflammation, including IL-6, TNF-α, IL-2, and CRP before and after surgery, and again at 2- and 6-week follow-up, to assess how chronic cannabis exposure modulates immune responses and wound healing in elective spine surgeries. In parallel, the investigators will obtain subjective pain assessments using validated scales and correlate these with intraoperative anesthetic dosing and inflammatory biomarker levels, thereby elucidating the interplay between cannabis-induced immune modulation in altering pain processing and wound healing. Impact: If successful, these studies will fill critical gaps in our understanding by: • Precisely characterizing how individual cannabis exposure parameters affect perioperative anesthetic and analgesic needs, thereby enabling personalized dosing protocols that reduce the risk of intraoperative awareness, cardiovascular instability, and prolonged recovery. • Defining the immunologic alterations associated with chronic cannabis use and their relationship to wound healing and postoperative pain, which may pave the way for novel interventions to optimize surgical outcomes. This integrative approach will advance the fields of anesthesiology, and surgical perioperative patient care and addiction research.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
210

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
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University Hospital
      • Columbia, Missouri, United States, 65211
        • Missouri Orthopaedic Institute

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Ambulatory and short-stay lumbar spine surgery patients

Description

Inclusion Criteria for both cannabis users and non-users:

  • 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).

Inclusion criteria for cannabis users:

• Any lifetime use of cannabis products irrespective of the strain, CBD/THC content, or frequency of use.

Exclusion Criteria:

  • 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.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intraoperative Propofol dose (mg/kg/hr)
Time Frame: Duration of surgery
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)
Time Frame: From enrollment to 6 week post-surgery
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)
Time Frame: From enrollment to 6 week post-surgery
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)
Time Frame: From enrollment to 6 week post-surgery
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)
Time Frame: From enrollment to 6 week post-surgery
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intraoperative opioid dose (MME)
Time Frame: Duration of surgery
Intraoperative opioid dose (MME) will be extracted from anesthesia records and entered into each patient's individual REDCap record by the study personnel.
Duration of surgery
Wound healing (cm^2)
Time Frame: From end of surgery to 6 week post-surgery
Wound healing will be assessed with the aid of the surgical team using the elliptical method, estimating area as (π × length × width)/4 from standardized incision measurements. The investigators will obtain these with the help of the surgical team in the operating room, and then remeasure at follow-up visits.
From end of surgery to 6 week post-surgery
Postoperative pain scores (0-10)
Time Frame: Post-operative day 0
Postoperative pain scores will be assessed with the participant using a visual analog scale 0-10, with 0 as no pain and 10 as the greatest amount of pain imaginable. The pain score will be obtained by nurses at 6 hour intervals after surgery till discharge. The data will be extracted from patient health records and entered into their respective records on REDCap.
Post-operative day 0
Mean arterial pressure (MAP) variability minutes
Time Frame: Duration of surgery
Intraoperative mean arterial pressure (MAP) variability will be measured as the number of minutes the MAP falls under 65 mmHg (i.e., hypotensive) during the surgery. The data will be extracted from patient electronic records and entered into their respective records on REDCap.
Duration of surgery
Heart rate (HR) variability in minutes
Time Frame: During surgery
Intraoperative heart rate (HR) variability will be measured as the number of minutes the HR falls under 65 bpm (i.e., bradycardia) or goes above 110 bpm (i.e., tachycardia) during the surgery. The data will be extracted from patient electronic records and entered into their respective records on REDCap.
During surgery
Total intraoperative vasopressor use (microgram/kg/min)
Time Frame: During surgery
Intraoperative vasopressor can be administered using multiple different drugs, so the investigators will sum all amounts used into a unified total amount adjusted to micrograms/kg/min. The information will be extracted from anesthesia records and entered into each patient's individual REDCap record by the study personnel.
During surgery
Postoperative opioid consumption (MME) during hospital stay
Time Frame: Post-operative day 0
Postoperative opioid consumption (MME) will be extracted patient electronic records and entered into their respective records on REDCap by study personnel.
Post-operative day 0
Pain assessment following discharge
Time Frame: Post-operative day 0 to 6 week post-surgery
The investigators will use ecological momentary assessments (EMAs) to administered questions remotely in two phases: phase 1 will have EMAs sent once daily for the 1st week following discharge from surgery, and phase 2 will have EMAs sent once weekly between the 2-week and 6-week follow-up sessions. The EMAs will ask patients about pain assessment using the same visual analog scale of 0-10, with 0 as no pain and 10 as the greatest amount of pain imaginable.
Post-operative day 0 to 6 week post-surgery
Opioid consumption (MME) following discharge
Time Frame: Post-operative day 0 to 6 week post-surgery
The investigators will use ecological momentary assessments (EMAs) to administered questions remotely in two phases: phase 1 will have EMAs sent once daily for the 1st week following discharge from surgery, and phase 2 will have EMAs sent once weekly between the 2-week and 6-week follow-up sessions. The EMAs will ask patients about medication adherence, patients will be asked to indicate if they took more than their prescribed amount of discharge opiate/analgesic medications and how much (measured in MME).
Post-operative day 0 to 6 week post-surgery
Cannabis use following discharge
Time Frame: Post-operative day 0 to 6 week post-surgery
The investigators will use ecological momentary assessments (EMAs) to administered questions remotely in two phases: phase 1 will have EMAs sent once daily for the 1st week following discharge from surgery, and phase 2 will have EMAs sent once weekly between the 2-week and 6-week follow-up sessions. The EMAs will ask participants about if and how much cannabis the participant used (measured in mg) going back 24 hours for phase 1, and 1 week for phase 2.
Post-operative day 0 to 6 week post-surgery
Cannabis cravings following discharge
Time Frame: Post-operative day 0 to 6 week post-surgery
The investigators will use ecological momentary assessments (EMAs) to administered questions remotely in two phases: phase 1 will have EMAs sent once daily for the 1st week following discharge from surgery, and phase 2 will have EMAs sent once weekly between the 2-week and 6-week follow-up sessions. The EMAs will ask participants about cannabis cravings with a 4-item Craving Questionnaire going back 24 hours for phase 1, and 1 week for phase 2. The craving questionnaire will ask the participants about intensity, frequency, and length of time of cravings on a scale of 0-4 (0 = None at all; 1= Slight; 2 = Moderate; 3 = Considerable; 4 = Extreme). The fourth question will ask about the total number of times the participants had cravings in the last 24 hours.
Post-operative day 0 to 6 week post-surgery

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Missouri-Columbia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Antoinette Burger, PhD, University of Missouri-Columbia
  • Study Director: Randi Foraker, PhD, University of Missouri-Columbia

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 11, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2128606

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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