Post-operative PainPhase 4NCT04346407
Dronabinol for Post-operative Pain After Lumbar Fusion
A Phase 4 study testing Dronabinol 2.5mg Cap in people with Post-operative Pain, run by Jeffrey L Gum MD at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- Dronabinol 2.5mg Cap
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 1 Sep 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Dronabinol on Post-operative Pain After Lumbar Fusion for Degenerative Disorders of the Spine
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
Read the 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.
- Conditions
- Post-operative Pain
- Being tested
- Dronabinol 2.5mg Cap, Placebo
- Keywords
- Lumbar Fusion, Post-operative Opioid Consumption, Post-operative Pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dronabinol 2.5mg CapDrug
Also called Marinol, Syndros
2.5mg of oral Dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery
PlaceboDrug
Also called Placebo capsule
Placebo capsule daily starting with pre-op cocktail and continued twice daily for three days after surgery
| Study group | Role | What they receive |
|---|---|---|
| Dronabinol | Experimental | 2.5mg of oral Dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Morphine Milligrams at 72 hours post-operative
Cumulative Morphine Milligrams consumed in-hospital 72 hours after surgery
Measured: 72 hours post-operative
Secondary outcomes (5)
Cumulative Morphine Milligrams at 24 hours post-operative
Cumulative Morphine Milligrams consumed in-hospital 24 hours after surgery
Measured: 24 hours post-operative
Cumulative Morphine Milligrams at 48 hours post-operative
Cumulative Morphine Milligrams consumed in-hospital 48 hours after surgery
Measured: 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
Measured: 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
Measured: 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
Measured: 72 hours post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start1 Sep 2020
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind Placebo controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeffrey L Gum MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jeffrey L Gum MD, Norton Leatherman Spine Center
- Investigators
- Jeffrey L Gum, MD, Principal investigator, Norton Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346407
- Sponsor's protocol ID
- 20.N0042
- Status last verified
- Feb 2021
- First submitted
- 10 Apr 2020
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dronabinol on Post-operative Pain After Lumbar Fusion for Degenerative Disorders of the Spine
- ClinicalTrials.gov ID
- NCT04346407
- Acronym / sponsor ID
- 20.N0042
- Conditions
- Post-operative Pain
- Keywords
- Lumbar Fusion, Post-operative Opioid Consumption, Post-operative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Jeffrey L Gum MDUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind Placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Dronabinol | Experimental | Drug: Dronabinol 2.5mg Cap2.5mg of oral Dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery |
| Placebo | Placebo comparator | Drug: PlaceboCapsule with placebo daily starting with pre-op cocktail and continued twice daily for three days after surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dronabinol 2.5mg CapAlso: Marinol, Syndros2.5mg of oral Dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery | Drug | Dronabinol |
| PlaceboAlso: Placebo capsulePlacebo capsule daily starting with pre-op cocktail and continued twice daily for three days after surgery | Drug | Placebo |
Primary outcome
Cumulative Morphine Milligrams at 72 hours post-operative
Time frame: 72 hours post-operative
Cumulative Morphine Milligrams consumed in-hospital 72 hours after surgery
5 secondary outcomes
Cumulative Morphine Milligrams at 24 hours post-operative
Time frame: 24 hours post-operative
Cumulative Morphine Milligrams at 48 hours post-operative
Time frame: 48 hours post-operative
Worst pain in past 24 hours post-operative
Time frame: 24 hours post-operative
Worst pain in past 48 hours post-operative
Time frame: 48 hours post-operative
Worst pain in past 72 hours post-operative
Time frame: 72 hours post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey L Gum, MD principal investigator
Norton Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dronabinol 2.5mg Cap in people with Post-operative Pain, run by Jeffrey L Gum MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Morphine Milligrams at 72 hours post-operative (time frame: 72 hours post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.