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Local Anesthetic

Pain Management for Postoperative Pain

Phase 2 & 3

Waitlist Available

Led By John Small, MD

Research Sponsored by Foundation for Orthopaedic Research and Education

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 0-72 hours with additional follow-up at 14 days (first clinic visit)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare the effectiveness of two different pain management methods for patients undergoing a specific type of back surgery. The researchers believe that using a certain type of nerve block with Exparel will be

Who is the study for?

This trial is for adults over 18 who are having a specific back surgery (1-3 level TLIF) and have a BMI between 18-35. They must not be pregnant, allergic to pain meds or local anesthetics, have had previous lumbar surgery, take high doses of opioids, or have muscle disorders like myasthenia gravis.

What is being tested?

The study compares two types of pain relief after back surgery: Exparel versus standard Bupivacaine. It aims to see if Exparel can better reduce pain, cut down on the need for narcotics, shorten hospital stays, and help patients get moving sooner.

What are the potential side effects?

Possible side effects from the drugs used in this trial include allergic reactions at the injection site, nausea, vomiting, constipation from narcotic use post-surgery and potential nerve damage though rare.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-72 hours with additional follow-up at 14 days (first clinic visit)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-72 hours with additional follow-up at 14 days (first clinic visit)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-72 hours with additional follow-up at 14 days (first clinic visit) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Compare efficacy of thoracolumbar interfacial plane block with Exparel vs. standard of care (0.25% Bupivacaine HCL) is surgical subjects undergoing 1-3 level elective transforaminal lumbar interbody fusion.

Secondary study objectives

Maximum ambulated distance

Numeric Rating Pain Scale

Numeric Rating Pain Scale (Physical Therapy)

+5 more

Awards & Highlights

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: Exparel TLIP InjectionExperimental Treatment1 Intervention

Subjects will receive 20 mL of EXPAREL 266mg mixed with 10 mL of 0.25% bupivacaine. A total of 30 mL of mixed solution is injected into the thoracolumbar interfacial plane.

Group II: Bupivicaine HCL TLIP InjectionActive Control1 Intervention

Standard of care will consist of 0.25% Bupivacaine HCl TLIP injection. Subjects will receive 30 mL of the solution, injected into the thoracolumbar interfacial plane.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exparel

2014

Completed Phase 4

~1670

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