Dronabinol for Post-operative Pain After Lumbar Fusion

Overview

Impact of 2.5mg of oral Dronabinol daily versus placebo on post-operative opioid consumption on patients aged 18 to 65 years old undergoing 1 to 3 level posterolateral fusion

Full Title of Study: “Impact of Dronabinol on Post-operative Pain After Lumbar Fusion for Degenerative Disorders of the Spine”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 1, 2023

Detailed Description

This is a randomized double-blind clinical trial comparing 2.5mg of oral Dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery versus placebo for patients aged 18 to 65 years old undergoing 1 to 3 level posterolateral fusion. The outcome of interest is post-operative opioid consumption defined as cumulative Morphine Milligram Equivalents at 72 hours after surgery.

Interventions

  • Drug: Dronabinol 2.5mg Cap
    • 2.5mg of oral Dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery
  • Drug: Placebo
    • Placebo capsule daily starting with pre-op cocktail and continued twice daily for three days after surgery

Arms, Groups and Cohorts

  • Experimental: Dronabinol
    • 2.5mg of oral Dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery
  • Placebo Comparator: Placebo
    • Capsule with placebo daily starting with pre-op cocktail and continued twice daily for three days after surgery

Clinical Trial Outcome Measures

Primary Measures

  • Cumulative Morphine Milligrams at 72 hours post-operative
    • Time Frame: 72 hours post-operative
    • Cumulative Morphine Milligrams consumed in-hospital 72 hours after surgery

Secondary Measures

  • Cumulative Morphine Milligrams at 24 hours post-operative
    • Time Frame: 24 hours post-operative
    • Cumulative Morphine Milligrams consumed in-hospital 24 hours after surgery
  • Cumulative Morphine Milligrams at 48 hours post-operative
    • Time Frame: 48 hours post-operative
    • Cumulative Morphine Milligrams consumed in-hospital 48 hours after surgery
  • Worst pain in past 24 hours post-operative
    • Time Frame: 24 hours post-operative
    • Worst pain in past 24 hours post-op on a scale of 0 to 10, with 0 as no pain and 10 as worst pain imaginable
  • Worst pain in past 48 hours post-operative
    • Time Frame: 48 hours post-operative
    • Worst pain in past 48 hours post-op on a scale of 0 to 10, with 0 as no pain and 10 as worst pain imaginable
  • Worst pain in past 72 hours post-operative
    • Time Frame: 72 hours post-operative
    • Worst pain in past 72 hours post-op on a scale of 0 to 10, with 0 as no pain and 10 as worst pain imaginable

Participating in This Clinical Trial

Inclusion Criteria

  • Age 18 to 65 years old – Patients undergoing 1 to 3 level posterolateral fusion – Opioid naïve or not – No prior spine fusion – Willing and able to sign an Informed Consent Exclusion Criteria:

  • Indication for surgery is fracture, tumor or infection – Comorbid psychiatric diagnosis requiring therapy and/or medication – Comorbid chronic pain syndrome (reflex sympathetic dystrophy, fibromyalgia) – Has hepatic disease – On workers compensation/disability/litigation – Known adverse reaction to medications to be administered – History of alcohol and drug abuse – On long-acting narcotic pain medication (including extended release narcotic pain medications and methadone)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jeffrey L Gum MD
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Jeffrey L Gum MD, Attending Spine Surgeon – Norton Leatherman Spine Center
  • Overall Official(s)
    • Jeffrey L Gum, MD, Principal Investigator, Norton Healthcare

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