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Local Anesthetic

Exparel TLIP Injection for Back 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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Maximum ambulated distance
Numeric Rating Pain Scale
Numeric Rating Pain Scale (Physical Therapy)
+5 more

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
~1620

Find a Location

Who is running the clinical trial?

Pacira Pharmaceuticals, IncIndustry Sponsor
136 Previous Clinical Trials
13,957 Total Patients Enrolled
1 Trials studying Back Pain
30 Patients Enrolled for Back Pain
Foundation for Orthopaedic Research and EducationLead Sponsor
13 Previous Clinical Trials
1,006 Total Patients Enrolled
John Small, MDPrincipal InvestigatorFlorida Orthopaedic Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for patients to enroll in this ongoing clinical trial?

"The current status on clinicaltrials.gov shows that recruitment for this trial is closed. The trial listing was initially posted on April 1, 2024, with the latest update occurring on April 3, 2024. Despite this specific study no longer accepting participants, there are currently active searches for candidates in a total of 764 other trials."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Analgesic Requirement for Post-Operative Pain Control in TLIP Interbody Fusion
2024. "Analgesic Requirement for Post-Operative Pain Control in TLIP Interbody Fusion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06350981.
All > Chronic Back Pain > Back Pain
~51 spots leftby Jan 2025
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