Dronabinol for Post-operative Pain After Lumbar Fusion

Jeffrey L Gum MD90 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Post-operative Pain

Interventions

Dronabinol 2.5mg CapDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (1)

Norton Healthcare

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

Cumulative Morphine Milligrams at 72 hours post-operative

Cumulative Morphine Milligrams consumed in-hospital 72 hours after surgery

Time frame: 72 hours post-operative

Secondary Outcomes

Cumulative Morphine Milligrams at 24 hours post-operative

Cumulative Morphine Milligrams consumed in-hospital 24 hours after surgery

Time frame: 24 hours post-operative

Cumulative Morphine Milligrams at 48 hours post-operative

Cumulative Morphine Milligrams consumed in-hospital 48 hours after surgery

Time frame: 48 hours post-operative

Worst pain in past 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

Time frame: 24 hours post-operative

Worst pain in past 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

Time frame: 48 hours post-operative

Worst pain in past 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

Time frame: 72 hours post-operative

Data from ClinicalTrials.gov

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