Dronabinol for Post-operative Pain After Lumbar Fusion

Impact of Dronabinol on Post-operative Pain After Lumbar Fusion for Degenerative Disorders of the Spine

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Post-operative Pain
• Intervention / Treatment: Drug: Dronabinol 2.5mg Cap; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dronabinol; 2.5mg of oral Dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery	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; Other Names: Marinol; Syndros
PLACEBO_COMPARATOR: Placebo; Capsule with placebo 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; Other Names: Placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Morphine Milligrams at 72 hours post-operative	Cumulative Morphine Milligrams consumed in-hospital 72 hours after surgery	72 hours post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Morphine Milligrams at 24 hours post-operative	Cumulative Morphine Milligrams consumed in-hospital 24 hours after surgery	24 hours post-operative
Cumulative Morphine Milligrams at 48 hours post-operative	Cumulative Morphine Milligrams consumed in-hospital 48 hours after surgery	48 hours post-operative
Worst pain in past 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	24 hours post-operative
Worst pain in past 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	48 hours post-operative
Worst pain in past 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	72 hours post-operative

Collaborators and Investigators

• Sponsor: Jeffrey L Gum MD
• Investigators: Principal Investigator: Jeffrey L Gum, MD, Norton Healthcare

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2020
• Primary Completion (ANTICIPATED): September 1, 2023
• Study Completion (ANTICIPATED): September 1, 2023

Study Registration Dates

• First Submitted: April 10, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (ACTUAL): April 15, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Lumbar Fusion; Post-operative Pain; Post-operative Opioid Consumption
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Psychotropic Drugs; Hallucinogens; Cannabinoid Receptor Agonists; Cannabinoid Receptor Modulators; Dronabinol
• Other Study ID Numbers: 20.N0042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No