Status:
WITHDRAWN
Multimodal Pain Package vs. Regular Formulation for Pain Management in Ambulatory Spinal Surgery
Lead Sponsor:
University of Miami
Conditions:
Spinal Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- Adults: males or non-pregnant females.
- Patients undergoing ambulatory microdiscectomies, foraminotomies, and spinal cord decompressions requiring pain control analgesics.
Exclusion
- Pregnancy
- 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.
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05965492
Start Date
June 1 2024
End Date
June 1 2025
Last Update
June 3 2025
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