Multimodal Pain Package vs. Regular Formulation for Pain Management in Ambulatory Spinal Surgery
NCT ID: NCT05965492
Last Updated: 2025-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2024-06-01
2025-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bottled pain formulations Group
Participants in this group will use the standard-of-care medication treatment for ambulatory spinal surgery prescribed to them in different bottles for 7 days.
Acetaminophen
Day 1 and Day 2: 1000 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 3000 mg.
Day 3 and Day 4: 825 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 2475 mg.
Day 5: 500 mg two times a day and 325 mg once a day administered via tablet by mouth for a total cumulative daily dose of 1325 mg.
Day 6: 500 mg once a day and 325mg twice a day administered via tablet by mouth for a total cumulative daily dose of 1150 mg.
Day 7: 500 mg twice a day administered via tablet by mouth for a total cumulative daily dose of 1000 mg.
Celebrex
Day 1: 200 mg twice a day administered via tablet by mouth for a total cumulative daily dose of 400 mg.
Day 2 and Day 3: 100 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 300 mg.
Day 4: 100 mg twice a day administered via tablet by mouth for a total cumulative daily dose of 200 mg.
Day 5: 50 mg twice a day administered via tablet by mouth for a total cumulative daily dose of 100 mg.
Not prescribed on Days 6 and 7.
Gabapentin
Day 1 and Day 2: 300 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 900 mg.
Day 3: 200 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 600 mg.
Day 4: 200 mg two times a day and 100mg once a day administered via tablet by mouth for a total cumulative daily dose of 500 mg.
Day 5: 100 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 300 mg.
Day 6: 100 mg two times a day administered via tablet by mouth for a total cumulative daily dose of 200 mg.
Day 7: 100 mg once a day administered via tablet by mouth for a total cumulative daily dose of 100 mg.
Famotidine
Day 1- Day 7: 20 mg once a day administered via tablet by mouth for a total cumulative daily dose of 20 mg.
Decadron
Day 1: 4 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 12 mg.
Day 2: 4 mg two times a day administered via tablet by mouth for a total cumulative daily dose of 8 mg.
Day 3: 2 mg two times a day administered via tablet by mouth for a total cumulative daily dose of 4 mg.
Not prescribed on Days 4 through 7.
Oxycodone
A prescription of oxycodone as per standard of care will be provided to participants in case of breakthrough pain.
Multi-Modal regimen Group
Participants in this group will receive the same drugs used during the standard-of-care treatment for ambulatory spinal surgery. However, the drugs will be prescribed using a simple multimodal medication pre-formulated package for 7 days.
Acetaminophen
Day 1 and Day 2: 1000 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 3000 mg.
Day 3 and Day 4: 825 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 2475 mg.
Day 5: 500 mg two times a day and 325 mg once a day administered via tablet by mouth for a total cumulative daily dose of 1325 mg.
Day 6: 500 mg once a day and 325mg twice a day administered via tablet by mouth for a total cumulative daily dose of 1150 mg.
Day 7: 500 mg twice a day administered via tablet by mouth for a total cumulative daily dose of 1000 mg.
Celebrex
Day 1: 200 mg twice a day administered via tablet by mouth for a total cumulative daily dose of 400 mg.
Day 2 and Day 3: 100 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 300 mg.
Day 4: 100 mg twice a day administered via tablet by mouth for a total cumulative daily dose of 200 mg.
Day 5: 50 mg twice a day administered via tablet by mouth for a total cumulative daily dose of 100 mg.
Not prescribed on Days 6 and 7.
Gabapentin
Day 1 and Day 2: 300 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 900 mg.
Day 3: 200 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 600 mg.
Day 4: 200 mg two times a day and 100mg once a day administered via tablet by mouth for a total cumulative daily dose of 500 mg.
Day 5: 100 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 300 mg.
Day 6: 100 mg two times a day administered via tablet by mouth for a total cumulative daily dose of 200 mg.
Day 7: 100 mg once a day administered via tablet by mouth for a total cumulative daily dose of 100 mg.
Famotidine
Day 1- Day 7: 20 mg once a day administered via tablet by mouth for a total cumulative daily dose of 20 mg.
Decadron
Day 1: 4 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 12 mg.
Day 2: 4 mg two times a day administered via tablet by mouth for a total cumulative daily dose of 8 mg.
Day 3: 2 mg two times a day administered via tablet by mouth for a total cumulative daily dose of 4 mg.
Not prescribed on Days 4 through 7.
Oxycodone
A prescription of oxycodone as per standard of care will be provided to participants in case of breakthrough pain.
Interventions
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Acetaminophen
Day 1 and Day 2: 1000 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 3000 mg.
Day 3 and Day 4: 825 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 2475 mg.
Day 5: 500 mg two times a day and 325 mg once a day administered via tablet by mouth for a total cumulative daily dose of 1325 mg.
Day 6: 500 mg once a day and 325mg twice a day administered via tablet by mouth for a total cumulative daily dose of 1150 mg.
Day 7: 500 mg twice a day administered via tablet by mouth for a total cumulative daily dose of 1000 mg.
Celebrex
Day 1: 200 mg twice a day administered via tablet by mouth for a total cumulative daily dose of 400 mg.
Day 2 and Day 3: 100 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 300 mg.
Day 4: 100 mg twice a day administered via tablet by mouth for a total cumulative daily dose of 200 mg.
Day 5: 50 mg twice a day administered via tablet by mouth for a total cumulative daily dose of 100 mg.
Not prescribed on Days 6 and 7.
Gabapentin
Day 1 and Day 2: 300 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 900 mg.
Day 3: 200 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 600 mg.
Day 4: 200 mg two times a day and 100mg once a day administered via tablet by mouth for a total cumulative daily dose of 500 mg.
Day 5: 100 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 300 mg.
Day 6: 100 mg two times a day administered via tablet by mouth for a total cumulative daily dose of 200 mg.
Day 7: 100 mg once a day administered via tablet by mouth for a total cumulative daily dose of 100 mg.
Famotidine
Day 1- Day 7: 20 mg once a day administered via tablet by mouth for a total cumulative daily dose of 20 mg.
Decadron
Day 1: 4 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 12 mg.
Day 2: 4 mg two times a day administered via tablet by mouth for a total cumulative daily dose of 8 mg.
Day 3: 2 mg two times a day administered via tablet by mouth for a total cumulative daily dose of 4 mg.
Not prescribed on Days 4 through 7.
Oxycodone
A prescription of oxycodone as per standard of care will be provided to participants in case of breakthrough pain.
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing ambulatory microdiscectomies, foraminotomies, and spinal cord decompressions requiring pain control analgesics.
Exclusion Criteria
* Active severe liver disease
* Chronic kidney disease 3a-5 (moderate to severe)
* Chronic obstructive pulmonary disease with impaired pulmonary function
* Chronic steroid use
* Chronic opioid use
* Current use of narcotics
* Allergy to sulfonamides
* Allergy to NSAIDs
* Allergy to Aspirin
* Allergy to Tylenol
* Allergy to Gabapentins
* Allergy to H2 blockers (cimetidine, famotidine)
* Allergy to steroid
* Current use of gabapentins for any medical condition
* Inability to be discharged home on the day of surgery
* Inability to swallow pills
* Myasthenia gravis
* History of gastrointestinal ulcers or stomach bleeding
* Have any condition that, in the investigator's opinion, will compromise the well-being of the patient or the study, or prevent the patient from meeting or performing study requirements.
18 Years
ALL
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Yiliam Rodriguez
Professor of Clinical
Principal Investigators
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Yiliam Yiliam, MD
Role: PRINCIPAL_INVESTIGATOR
Professor of Clinical
Other Identifiers
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20230423
Identifier Type: -
Identifier Source: org_study_id
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