Dronabinol for Post-operative Pain After Lumbar Fusion

• Status: Enrolling by invitation
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jeffrey L Gum MD
• Treatments: Dronabinol

Criteria

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)