Dronabinol for Post-operative Pain After Lumbar Fusion

Jeffrey L Gum MD

Status and phase

Unknown

Phase 4

Conditions

Post-operative Pain

Treatments

Drug: Placebo

Drug: Dronabinol 2.5mg Cap

Study type

Interventional

Funder types

Other

Identifiers

NCT04346407

20.N0042

Details and patient eligibility

About

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

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)