Postoperative PainCannabisNCT06903624
Cannabis in Postoperative Pain Management
An observational study of Postoperative Pain, run by Assuta Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- How many people
- 70,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 24 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients that underwent painfull surgical procedures will be cosidered in the study.
Who may be able to join
- Patients aged 18 and over.
- Patients who underwent surgery under general anesthesia.
Who cannot join
- 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.
About this study
Official title: Exploring the Impact of Cannabis on Postoperative Pain Management and Analgesic Consumption
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.
Read more
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.
Read the detailed description
Study Design This retrospective cohort study analyzes anonymized medical records of surgical patients who underwent surgery between January 2017 and January 2025 at the Assuta hospitals network.
Data Source Electronic health records from a hospital database, including postoperative pain scores, analgesic administration, and patient demographics. Pain levels will be assessed during hospitalization for up to one-week post-surgery. In the cannabis use research group, participants will be asked to report their daily use for at least the past six months. The study will utilize MDClone, a healthcare data analytics platform, to extract and analyze anonymized electronic health records. MDClone enables the generation of synthetic, privacy-preserving patient data, ensuring compliance with ethical and regulatory standards while allowing for robust statistical analysis.
Variables for Analysis
- Demographics: Age, sex, BMI, Hospital stay, Operation duration, type of anesthesia, region of residence, marital status.
- Medical History: Comorbidities, history of trauma, psychiatric conditions, prior surgeries.
- Surgical Data: Type of procedure, intraoperative factors, postoperative complications.
- Pain Management: Pain scores (e.g., VAS), opioid and non-opioid analgesic doses, use of regional anesthesia.
- Psychosocial Factors: psychiatric medication use (e.g., antidepressants).
- Hospital Course: Length of stay, ICU admissions
The study population The expected number of participants is 70,000 participants from the five medical canters in the Assuta network.
Statistical analysis include:
- Descriptive Analysis - Baseline characteristics will be summarized using means, medians, and proportions.
- Comparative Analysis - Pain levels and analgesic use across different surgical types, comorbidities and between cannabis users vs. non-users will be compared using t-tests, chi-square tests, or non-parametric equivalents.
- Machine Learning Models - Supervised learning algorithms (e.g., logistic regression, random forests, gradient boosting) will be employed to predict high analgesic requirements based on preoperative and intraoperative variables.
- Validation \& Model Performance - ROC-AUC, sensitivity, and specificity will be used to assess model accuracy.
- Conditions
- Postoperative Pain
- Keywords
- Cannabis, Postoperative pain, Analgesics, Opioids
- Medical subject headings
- Pain, Postoperative, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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-)
Measured: 7 days
Secondary outcomes (1)
Analgesic Consumption
total amount of analgesics required during the postoperative period including opioids
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2025
- Study start1 Jan 2016
- Primary completion25 Feb 2025
- Study completion24 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assuta Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Gabriel Susmallian, Assuta Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903624
- Sponsor's protocol ID
- 005-2025
- Other IDs
- 005-2025
- Acronym
- Cannabis
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Impact of Cannabis on Postoperative Pain Management and Analgesic Consumption
- ClinicalTrials.gov ID
- NCT06903624
- Acronym / sponsor ID
- Cannabis / 005-2025
- Conditions
- Postoperative Pain
- Keywords
- Cannabis, Postoperative pain, Analgesics, Opioids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70,000 participants (actual)
- Lead sponsor
- Assuta Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 25 Feb 2025 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 31 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Design This retrospective cohort study analyzes anonymized medical records of surgical patients who underwent surgery between January 2017 and January 2025 at the Assuta hospitals network.
Data Source Electronic health records from a hospital database, including postoperative pain scores, analgesic administration, and patient demographics. Pain levels will be assessed during hospitalization for up to one-week post-surgery. In the cannabis use research group, participants will be asked to report their daily use for at least the past six months. The study will utilize MDClone, a healthcare data analytics platform, to extract and analyze anonymized electronic health records. MDClone enables the generation of synthetic, privacy-preserving patient data, ensuring compliance with ethical and regulatory standards while allowing for robust statistical analysis.
Variables for Analysis
- Demographics: Age, sex, BMI, Hospital stay, Operation duration, type of anesthesia, region of residence, marital status.
- Medical History: Comorbidities, history of trauma, psychiatric conditions, prior surgeries.
- Surgical Data: Type of procedure, intraoperative factors, postoperative complications.
- Pain Management: Pain scores (e.g., VAS), opioid and non-opioid analgesic doses, use of regional anesthesia.
- Psychosocial Factors: psychiatric medication use (e.g., antidepressants).
- Hospital Course: Length of stay, ICU admissions
The study population The expected number of participants is 70,000 participants from the five medical canters in the Assuta network.
Statistical analysis include:
- Descriptive Analysis - Baseline characteristics will be summarized using means, medians, and proportions.
- Comparative Analysis - Pain levels and analgesic use across different surgical types, comorbidities and between cannabis users vs. non-users will be compared using t-tests, chi-square tests, or non-parametric equivalents.
- Machine Learning Models - Supervised learning algorithms (e.g., logistic regression, random forests, gradient boosting) will be employed to predict high analgesic requirements based on preoperative and intraoperative variables.
- Validation \& Model Performance - ROC-AUC, sensitivity, and specificity will be used to assess model accuracy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients that underwent painfull surgical procedures will be cosidered in the study.
Key inclusion criteria (2 listed)
- Patients aged 18 and over.
- Patients who underwent surgery under general anesthesia.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain Intensity
Time frame: 7 days
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-)
1 secondary outcome
Analgesic Consumption
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by Assuta Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025; AzTrials last refreshed its copy on 2 Nov 2026.