INTERVENTIONALUNKNOWNNCT04346407

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

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

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2021-02-12

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE4
Enrollment: 90 (ESTIMATED)
Start date: 2020-09-01
Sponsor: Jeffrey L Gum MD
Design: RANDOMIZED · PARALLEL · TREATMENT
Locations: 1
Results record: Not present in registry snapshot

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.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

Delta(9)-tetrahydrocannabinol

Medicines

DRONABINOL DRONABINOL DRONABINOL DRONABINOL MARINOL Marinol MARINOL SYNDROS

Interventions

What was registered

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

Marinol · Syndros

DRUG

Placebo

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

Placebo capsule

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Not accepted

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)

primary outcomes

primary measures

Cumulative Morphine Milligrams at 72 hours post-operative

Time frame: 72 hours post-operative

Cumulative Morphine Milligrams consumed in-hospital 72 hours after surgery

secondary outcomes

secondary measures

Cumulative Morphine Milligrams at 24 hours post-operative

Time frame: 24 hours post-operative

Cumulative Morphine Milligrams consumed in-hospital 24 hours after surgery

Cumulative Morphine Milligrams at 48 hours post-operative

Time frame: 48 hours post-operative

Cumulative Morphine Milligrams consumed in-hospital 48 hours after surgery

Worst pain in past 24 hours post-operative

Time frame: 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

Worst pain in past 48 hours post-operative

Time frame: 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

Worst pain in past 72 hours post-operative

Time frame: 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

Publications

Locally readable linked articles

No exact PMID-linked public article is currently readable locally.

Snapshot provenance

Snapshot: e2fd9ae9-0d65-4eb9-b355-fcc0059e5282
Retrieved: 11/09/2026, 14:54:54
SHA-256: 1f32d3075ae9c241b71229eac49dc69d8f54562363cad2760f193b8a54f58335