Nabilone Use For Acute Pain in Inflammatory Bowel Disease Patients
Status:
Not yet recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
N/A
Details
Lead Sponsor:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital