RECRUITING

Multimodal Pain Package vs. Regular Formulation for Pain Management in Ambulatory Spinal Surgery

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Conditions

Spinal Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this research is to compare two outpatient pain management strategies in patients undergoing spinal surgeries such as microdiscectomies, foraminotomies, and spinal decompressions.

Official Title

Optimal Multimodal Pain Management Package Versus Regular Bottled Pain Formulation for Outpatient Use Following Microdiscectomies , Foraminotomies, and Spinal Decompressions: A Randomized Control Trial Comparing Two Strategies

Quick Facts

Study Start:2024-06-01
Study Completion:2025-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05965492

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults: males or non-pregnant females.
  2. * Patients undergoing ambulatory microdiscectomies, foraminotomies, and spinal cord decompressions requiring pain control analgesics.
  1. * Pregnancy
  2. * Active severe liver disease
  3. * Chronic kidney disease 3a-5 (moderate to severe)
  4. * Chronic obstructive pulmonary disease with impaired pulmonary function
  5. * Chronic steroid use
  6. * Chronic opioid use
  7. * Current use of narcotics
  8. * Allergy to sulfonamides
  9. * Allergy to NSAIDs
  10. * Allergy to Aspirin
  11. * Allergy to Tylenol
  12. * Allergy to Gabapentins
  13. * Allergy to H2 blockers (cimetidine, famotidine)
  14. * Allergy to steroid
  15. * Current use of gabapentins for any medical condition
  16. * Inability to be discharged home on the day of surgery
  17. * Inability to swallow pills
  18. * Myasthenia gravis
  19. * History of gastrointestinal ulcers or stomach bleeding
  20. * 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.

Contacts and Locations

Study Contact

Yiliam Rodriguez, MD
CONTACT
(305) 5855456
yrodriguez4@miami.edu

Principal Investigator

Yiliam Yiliam, MD
PRINCIPAL_INVESTIGATOR
Professor of Clinical

Study Locations (Sites)

University of Miami
Miami, Florida, 33136
United States
university of Miami
Miami, Florida, 33136
United States

Collaborators and Investigators

Sponsor: University of Miami

  • Yiliam Yiliam, MD, PRINCIPAL_INVESTIGATOR, Professor of Clinical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-01
Study Completion Date2025-06-01

Study Record Updates

Study Start Date2024-06-01
Study Completion Date2025-06-01

Terms related to this study

Additional Relevant MeSH Terms

  • Spinal Disorder