Comparing pain management methods for spinal surgery patients
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
This study is testing a new combination of pain relief methods to see if they work better than standard treatments for patients recovering from outpatient spinal surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Trial ID | NCT05965492 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a multimodal pain management package compared to a regular formulation in patients undergoing outpatient spinal surgeries, such as microdiscectomies and spinal decompressions. The study will involve administering a combination of medications, including acetaminophen, Celebrex, Gabapentin, Famotidine, and Decadron, to assess pain control and recovery outcomes. By comparing these two approaches, the trial seeks to identify the most effective strategy for managing postoperative pain in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults undergoing ambulatory spinal surgeries who require pain control.
Not a fit: Patients with severe liver disease, chronic kidney disease, or those currently using narcotics or certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing spinal surgery, enhancing their recovery experience.
How similar studies have performed: Other studies have shown promise in multimodal pain management approaches, suggesting potential success for this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults: males or non-pregnant females. * Patients undergoing ambulatory microdiscectomies, foraminotomies, and spinal cord decompressions requiring pain control analgesics. Exclusion Criteria: * 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.
Where this trial is running
Miami, Florida and 1 other locations
- University of Miami — Miami, Florida, United States (Not_yet_recruiting)
- university of Miami — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Yiliam Yiliam, MD — Professor of Clinical
- Study coordinator: Yiliam Rodriguez, MD
- Email: yrodriguez4@miami.edu
- Phone: (305) 5855456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.