Dronabinol for Post-operative Pain After Lumbar Fusion

NCT04346407 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: 20.N0042
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Post-operative Pain

Keywords

Lumbar Fusion; Post-operative Opioid Consumption; Post-operative Pain

Outcome Measures

Primary Outcomes (1)

• Cumulative Morphine Milligrams at 72 hours post-operative

  Cumulative Morphine Milligrams consumed in-hospital 72 hours after surgery

  72 hours post-operative

Secondary Outcomes (5)

• Cumulative Morphine Milligrams at 24 hours post-operative

  24 hours post-operative

• Cumulative Morphine Milligrams at 48 hours post-operative

  48 hours post-operative

• Worst pain in past 24 hours post-operative

  24 hours post-operative

• Worst pain in past 48 hours post-operative

  48 hours post-operative

• Worst pain in past 72 hours post-operative

  72 hours post-operative

Study Arms (2)

Dronabinol

EXPERIMENTAL

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

Drug: Dronabinol 2.5mg Cap

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Dronabinol 2.5mg Cap DRUG

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

Also known as: Marinol, Syndros

Dronabinol

Placebo DRUG

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

Also known as: Placebo capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jeffrey L Gum MD: lead

Study Sites (1)

Norton Healthcare

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dronabinol; Capsules

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Jeffrey L Gum, MD

  Norton Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo, randomization and blinding will be maintained by the Hospital Pharmacy
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Spine Surgeon

Model Details: Double-blind Placebo controlled

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 15, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: February 12, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)