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Opioid Analgesic

Spinal Morphine for Local Anesthesia

Phase 4

Recruiting

Led By Engy T Said, MD

Research Sponsored by University of California, San Diego

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 post-operative day 0, 1, 2, 3, 4, 14, 30

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial tests if adding ESP catheters to the current pain management plan improves pain relief after liver surgery. The study targets adults having liver surgery, as this procedure is very painful and current methods don't last long enough. ESP catheters provide continuous pain relief by blocking pain signals near the spine. This method has shown promise in managing both short-term and long-term pain, but further studies are needed to confirm its effectiveness and safety.

Eligible Conditions

Local Anesthesia
Acute Pain
Anesthesia
Liver Resection

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-operative day 0, 1, 2, 3, 4, 14, 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-operative day 0, 1, 2, 3, 4, 14, 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-operative day 0, 1, 2, 3, 4, 14, 30 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Total opioid requirement postoperative day (POD) 1-3

Secondary study objectives

Discharge opioids and refills.

Hospital Length Of Stay

Nausea

+4 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active TreatmentExperimental Treatment2 Interventions

This group will receive a continuous erector spinae block catheter followed by an infusion of ropivacaine 0.2% at 10ml automatic set bolus per 120 minutes with 2ml/hr continuous infusion (14mls total every 2 hours per catheter)

Group II: PlaceboPlacebo Group2 Interventions

This group will receive a superficially placed (taped to the surface) erector spinae block catheter with a ropivacaine 0.2% infusion at 0.1ml /hr

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Spinal Morphine

2023

Completed Phase 4

~170

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