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Multimodal Pain Package for Post-Spinal Surgery Pain Management

Phase 3

Recruiting

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

Pivotal Trial

No Placebo-Only Group

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence measured by the self-report medication nonadherence scale

Ease of use as measured by Likert Scale

Satisfaction measured by Satisfaction Likert Scale

Secondary study objectives

Number of pain pills

Awards & Highlights

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.

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

~1220

Acetaminophen

2017

Completed Phase 4

~2030