Nabilone Use for Acute Pain in Inflammatory Bowel Disease Patients With Chronic Opioid Use Undergoing Gastrointestinal Surgery: A Single-centered Randomized Controlled Trial

NCT03422861 NA UNKNOWN

This is a clinical trial of nabilone for patients with Inflammatory Bowel Disease (IBD) who are undergoing IBD-related surgery (Any abdominal surgery lasting for more than one hour). This study would include a total of 80 patients undergoing general surgery who will have Intravenous Patient Controlled Analgesia (IVPCA) after surgery. It is the intention to randomize these patients postoperatively into 2 groups of 40 patients: 1. Patients who are chronic opioid users for chronic pain and have been exposed to cannabis or cannabinoid products, treated with IV PCA and nabilone as per protocol. 2. Patients who are chronic opioid users for chronic pain and have been exposed to cannabis or cannabinoid products, treated with IV PCA and placebo as per protocol. The goal is two-fold. One is to demonstrate that patients will benefit from post-operative nabilone administration to achieve/maintain the opioid-sparing and pain modulation effects. Second is to demonstrate patients will benefit from the anti-inflammatory and immunomodulatory effects of nabilone to alleviate IBD symptoms and enhance recovery.

Details

Lead sponsor	Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Phase	NA
Status	UNKNOWN
Enrolment	80
Start date	2023-12
Completion	2024-12

Conditions

• Inflammatory Bowel Diseases

Interventions

• Nabilone
• Placebos

Primary outcomes

• Total amount of opioid consumption postoperatively — For up to 72 hours after surgery
  All the narcotic consumption will be converted to IV morphine equivalents using standard conversation factors

Countries

Canada