Dronabinol for Post-operative Pain After Lumbar Fusion

Post-operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04346407
• Other study ID #: 20.N0042
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: September 1, 2020
• Est. completion date: September 1, 2023

Study information

• Verified date: February 2021
• Source: Norton Leatherman Spine Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain

Intervention

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
• Placebo
Placebo capsule daily starting with pre-op cocktail and continued twice daily for three days after surgery

Locations

Country	Name	City	State
United States	Norton Healthcare	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Jeffrey L Gum MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Morphine Milligrams at 72 hours post-operative	Cumulative Morphine Milligrams consumed in-hospital 72 hours after surgery	72 hours post-operative
Secondary	Cumulative Morphine Milligrams at 24 hours post-operative	Cumulative Morphine Milligrams consumed in-hospital 24 hours after surgery	24 hours post-operative
Secondary	Cumulative Morphine Milligrams at 48 hours post-operative	Cumulative Morphine Milligrams consumed in-hospital 48 hours after surgery	48 hours post-operative
Secondary	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
Secondary	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
Secondary	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