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Nabilone Use For Acute Pain in Inflammatory Bowel Disease Patients

NCT03422861 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-06-07

No results posted yet for this study

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.

Conditions

  • Inflammatory Bowel Diseases

Interventions

DRUG

Nabilone

Treatment regimen will involve nabilone capsule administration starting with 1mg BID orally first administered on POD #0. The patient will be continued on this medication for 72 hours

DRUG

Placebos

Treatment regimen will involve placebo capsule administration, identical in colour, shape, size, taste and smell to the nabilone capsules, starting orally first administered on POD #0. The patient will be continued on this medication for 72 hours

Sponsors & Collaborators

  • Samuel Lunenfeld Research Institute, Mount Sinai Hospital

    lead OTHER

Principal Investigators

  • Naveed Siddiqui, M.D · Mount Sinai Hospital Department of Anesthesia and Pain Management

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-31
Primary Completion
2024-09-30
Completion
2024-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03422861 on ClinicalTrials.gov