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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04346407
Other study ID # 20.N0042
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received
Last updated
Start date September 1, 2020
Est. completion date September 1, 2023

Study information

Verified date February 2021
Source Norton Leatherman Spine Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 90
Est. completion date September 1, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Norton Healthcare Louisville Kentucky

Sponsors (1)

Lead Sponsor Collaborator
Jeffrey L Gum MD

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cumulative Morphine Milligrams at 72 hours post-operative Cumulative Morphine Milligrams consumed in-hospital 72 hours after surgery 72 hours post-operative
Secondary Cumulative Morphine Milligrams at 24 hours post-operative Cumulative Morphine Milligrams consumed in-hospital 24 hours after surgery 24 hours post-operative
Secondary Cumulative Morphine Milligrams at 48 hours post-operative Cumulative Morphine Milligrams consumed in-hospital 48 hours after surgery 48 hours post-operative
Secondary 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 24 hours post-operative
Secondary 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 48 hours post-operative
Secondary 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 72 hours post-operative
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