Back to resultsDronabinol for Post-operative Pain After Lumbar Fusion
Primary Purpose
Post-operative Pain
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dronabinol 2.5mg Cap
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Post-operative Pain focused on measuring Lumbar Fusion, Post-operative Opioid Consumption, Post-operative Pain
Eligibility 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)
Sites / Locations
- Norton Healthcare
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dronabinol
Placebo
Arm Description
2.5mg of oral Dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery
Capsule with placebo daily starting with pre-op cocktail and continued twice daily for three days after surgery
Outcomes
Primary Outcome Measures
Cumulative Morphine Milligrams at 72 hours post-operative
Cumulative Morphine Milligrams consumed in-hospital 72 hours after surgery
Secondary Outcome Measures
Cumulative Morphine Milligrams at 24 hours post-operative
Cumulative Morphine Milligrams consumed in-hospital 24 hours after surgery
Cumulative Morphine Milligrams at 48 hours post-operative
Cumulative Morphine Milligrams consumed in-hospital 48 hours after surgery
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04346407
Brief Title
Dronabinol for Post-operative Pain After Lumbar Fusion
Official Title
Impact of Dronabinol on Post-operative Pain After Lumbar Fusion for Degenerative Disorders of the Spine
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jeffrey L Gum MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain
Keywords
Lumbar Fusion, Post-operative Opioid Consumption, Post-operative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Double-blind Placebo controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Placebo, randomization and blinding will be maintained by the Hospital Pharmacy
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dronabinol
Arm Type
Experimental
Arm Description
2.5mg of oral Dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Capsule with placebo daily starting with pre-op cocktail and continued twice daily for three days after surgery
Intervention Type
Drug
Intervention Name(s)
Dronabinol 2.5mg Cap
Other Intervention Name(s)
Marinol, Syndros
Intervention Description
2.5mg of oral Dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo capsule
Intervention Description
Placebo capsule daily starting with pre-op cocktail and continued twice daily for three days after surgery
Primary Outcome Measure Information:
Title
Cumulative Morphine Milligrams at 72 hours post-operative
Description
Cumulative Morphine Milligrams consumed in-hospital 72 hours after surgery
Time Frame
72 hours post-operative
Secondary Outcome Measure Information:
Title
Cumulative Morphine Milligrams at 24 hours post-operative
Description
Cumulative Morphine Milligrams consumed in-hospital 24 hours after surgery
Time Frame
24 hours post-operative
Title
Cumulative Morphine Milligrams at 48 hours post-operative
Description
Cumulative Morphine Milligrams consumed in-hospital 48 hours after surgery
Time Frame
48 hours post-operative
Title
Worst pain in past 24 hours post-operative
Description
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
Title
Worst pain in past 48 hours post-operative
Description
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
Title
Worst pain in past 72 hours post-operative
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey L Gum, MD
Organizational Affiliation
Norton Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norton Healthcare
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dronabinol for Post-operative Pain After Lumbar Fusion
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