Dronabinol for Post-operative Pain After Lumbar Fusion

Status unconfirmed · Phase 4 · Has a placebo group

Conditions studied: Post-operative Pain

In brief

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

Key facts

Study ID

NCT04346407

Run by

Jeffrey L Gum MD

People needed

90

Starts

2020-09-01

Expected to finish

2023-09-01

Last updated by the study team

2021-02-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Norton Healthcare — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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