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Multimodal Pain Package for Post-Spinal Surgery Pain Management
Phase 3
Waitlist Available
Led By Yiliam Yiliam, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 days
Awards & highlights
Study Summary
This trial will compare two pain relief options for people who have had spinal surgery.
Who is the study for?
This trial is for adults needing pain management after outpatient spinal surgeries like microdiscectomies. Candidates must not be pregnant, have severe liver or moderate to severe kidney disease, impaired lung function, allergies to specific drugs (sulfonamides, NSAIDs, aspirin), or conditions preventing same-day discharge.Check my eligibility
What is being tested?
The study compares a multimodal pain package including Decadron, Gabapentin, Famotidine, Oxycodone and Celebrex with regular formulations for managing post-surgical pain in patients who've had certain spinal procedures.See study design
What are the potential side effects?
Potential side effects may include stomach issues from NSAIDs like Celebrex; drowsiness and dizziness from Gabapentin; increased infection risk from steroids like Decadron; and constipation or addiction risks associated with opioids like Oxycodone.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence measured by the self-report medication nonadherence scale
Ease of use as measured by Likert Scale
Satisfaction measured by Satisfaction Likert Scale
Secondary outcome measures
Number of pain pills
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Multi-Modal regimen GroupExperimental Treatment6 Interventions
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.
Group II: Bottled pain formulations GroupActive Control6 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Famotidine
2005
Completed Phase 4
~1700
Gabapentin
2013
Completed Phase 4
~1550
Oxycodone
2014
Completed Phase 4
~2210
Acetaminophen
2017
Completed Phase 4
~2030
Decadron
1998
Completed Phase 3
~460
Celebrex
2018
Completed Phase 4
~2700
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
899 Previous Clinical Trials
409,632 Total Patients Enrolled
Yiliam Yiliam, MDPrincipal InvestigatorProfessor of Clinical
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have COPD with reduced lung function.I cannot swallow pills.I have myasthenia gravis.I am allergic to certain stomach acid medications.I cannot go home the same day I have surgery.I have had stomach ulcers or bleeding in the past.I am on long-term steroids.I am currently taking gabapentin for a medical condition.I have a severe liver condition.I am an adult and not pregnant.I am having a minor spine surgery and need medication for pain relief.My kidney function is moderately to severely reduced.
Research Study Groups:
This trial has the following groups:- Group 1: Multi-Modal regimen Group
- Group 2: Bottled pain formulations Group
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for subjects to participate in this experiment?
"The available data on clinicaltrials.gov suggests that sign-ups for this trial are temporarily suspended. Initially posted on September 1st 2023, the last edit to its information was made July 27th of the same year. Nevertheless, there are 32 other active trials in search of participants presently."
Answered by AI
What is the safety profile of Multi-Modal regimen Group for patients?
"Our team at Power has determined that the Multi-Modal regimen Group is a safe option, as it has earned a score of 3. This rating was given due to there being multiple rounds of data confirming its efficacy and safety in clinical trials."
Answered by AI
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