Post-operative Pain
Conditions
Keywords
Lumbar Fusion, Post-operative Opioid Consumption, Post-operative Pain
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.
Interventions
DRUGDronabinol 2.5mg Cap
2.5mg of oral Dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery
DRUGPlacebo
Placebo capsule daily starting with pre-op cocktail and continued twice daily for three days after surgery
Sponsors
Jeffrey L Gum MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Placebo, randomization and blinding will be maintained by the Hospital Pharmacy
Intervention model description
Double-blind Placebo controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Morphine Milligrams at 72 hours post-operative | 72 hours post-operative | Cumulative Morphine Milligrams consumed in-hospital 72 hours after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Morphine Milligrams at 24 hours post-operative | 24 hours post-operative | Cumulative Morphine Milligrams consumed in-hospital 24 hours after surgery |
| Cumulative Morphine Milligrams at 48 hours post-operative | 48 hours post-operative | Cumulative Morphine Milligrams consumed in-hospital 48 hours after surgery |
| Worst pain in past 24 hours post-operative | 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 | 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 | 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 |
Countries
United States
Outcome results
None listed