Dronabinol for Post-operative Pain After Lumbar Fusion

Phase 4

• Conditions: Post-operative Pain
• Interventions: Drug: Dronabinol 2.5mg Cap; Drug: Placebo

• Registration Number: NCT04346407
• Lead Sponsor: Jeffrey L Gum MD

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-04-10
• Study First Submitted QC: 2020-04-13
• Study First Posted: 2020-04-15
• Study Start: 2020-09-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-12
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dronabinol	Dronabinol 2.5mg Cap	2.5mg of oral Dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery
Placebo	Placebo	Capsule with placebo daily starting with pre-op cocktail and continued twice daily for three days after surgery

Primary Outcome Measures

Name	Time	Method
Cumulative Morphine Milligrams at 72 hours post-operative	72 hours post-operative	Cumulative Morphine Milligrams consumed in-hospital 72 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Cumulative Morphine Milligrams at 24 hours post-operative	24 hours post-operative	Cumulative Morphine Milligrams consumed in-hospital 24 hours after surgery
Cumulative Morphine Milligrams at 48 hours post-operative	48 hours post-operative	Cumulative Morphine Milligrams consumed in-hospital 48 hours after surgery
Worst pain in past 24 hours post-operative	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 72 hours post-operative	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
Worst pain in past 48 hours post-operative	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

Trial Locations

Locations (1)

Norton Healthcare; 🇺🇸 Louisville, Kentucky, United States