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临床试验/NCT06903624
NCT06903624已完成不适用

Exploring the Impact of Cannabis on Postoperative Pain Management and Analgesic Consumption

Assuta Medical Center0 个研究点目标入组 70,000 人开始时间: 2016年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
70,000
主要终点
Pain Intensity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Pain Intensity

时间窗: 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-)

次要结局

  • Analgesic Consumption(7 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sergio Gabriel Susmallian

Medicine Doctor

Assuta Medical Center

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