Dronabinol for Post-operative Pain After Lumbar Fusion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2023-09-01

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Post-operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blind Placebo controlled

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Placebo, randomization and blinding will be maintained by the Hospital Pharmacy

Study Groups

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Dronabinol

2.5mg of oral Dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery

Group Type EXPERIMENTAL

Dronabinol 2.5mg Cap

Intervention Type DRUG

2.5mg of oral Dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery

Placebo

Capsule with placebo daily starting with pre-op cocktail and continued twice daily for three days after surgery

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Dronabinol 2.5mg Cap

2.5mg of oral Dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Marinol Syndros Placebo capsule

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No