UnknownPhase 4

Dronabinol for Post-operative Pain After Lumbar Fusion

United States90 participantsStarted 2020-09-01

Plain-language 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

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Cumulative Morphine Milligrams at 72 hours post-operative

Timeframe: 72 hours post-operative

Trial details

NCT IDNCT04346407

SponsorJeffrey L Gum MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-01

View on ClinicalTrials.gov More Post-operative Pain trials