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Local Anesthetic

ESP Block with Liposomal Bupivacaine for Lumbar Radiculopathy

Phase 4
Waitlist Available
Led By Christina Jeng, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who are scheduled to undergo lumbar spinal surgery (1-2 level) and willing and able to provide informed consent
Adults aged greater than or equal to 18 years old and less than or equal to 85 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours
Awards & highlights

Study Summary

This trial will compare long-term benefits of liposomal bupivacaine in an ESP block for patients undergoing lumbar spinal fusion surgery.

Who is the study for?
This trial is for adults aged 18-85 scheduled for lumbar spinal surgery (1-2 level) who can consent. It's not for those with allergies to study drugs, kidney issues, pregnancy, severe health conditions (ASA status >3), on immunosuppressants, chronic opioid users (>3 months), or with a history of substance abuse or intolerance to NSAIDs.Check my eligibility
What is being tested?
The study tests if adding liposomal bupivacaine to an Erector Spinae Plane (ESP) block benefits patients undergoing lumbar fusion surgery more than the standard ESP block with plain bupivacaine. The focus is on reducing opioid use and improving pain management post-surgery.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site like pain or swelling, potential nerve damage risks associated with spine injections, allergic reactions to bupivacaine components which could range from mild skin reactions to more serious symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for 1-2 level lumbar spinal surgery and agree to participate.
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I am between 18 and 85 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Postoperative opioid consumption during first 72 hours
Secondary outcome measures
Change in Pain score
Change in Quality of Recovery (QOR 15)
Hospital length of stay
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Liposomal Bupivacaine and BupivacaineExperimental Treatment2 Interventions
liposomal bupivacaine in addition to 0.25% bupivacaine in ESP blocks
Group II: Bupivacaine onlyActive Control1 Intervention
bupivacaine 0.25% in ESP blocks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liposomal bupivacaine
2016
Completed Phase 4
~1970
Bupivacaine
2013
Completed Phase 4
~1530

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
858 Previous Clinical Trials
524,273 Total Patients Enrolled
Christina Jeng, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
2 Previous Clinical Trials
103 Total Patients Enrolled

Media Library

Bupivacaine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT05417113 — Phase 4
Lumbar Radiculopathy Research Study Groups: Bupivacaine only, Liposomal Bupivacaine and Bupivacaine
Lumbar Radiculopathy Clinical Trial 2023: Bupivacaine Highlights & Side Effects. Trial Name: NCT05417113 — Phase 4
Bupivacaine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05417113 — Phase 4

Frequently Asked Questions

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

To what degree may Bupivacaine present risks to those who use it?

"Patient-safety is paramount and, with this being a Phase 4 trial that has already been approved, Bupivacaine received an optimal rating of 3."

Answered by AI

Are enrollees still being taken for this clinical experiment?

"Affirmative. Clinicaltrials.gov data shows that this trial, which was initially posted on August 31st 2022, is presently enrolling volunteers. In total 84 individuals between 1 centre are needed for the study."

Answered by AI

Am I able to join the experiment?

"Participants for this trial must fit within the 18-85 age range and have lumbar region pain. A total of 84 people are being accepted into the study."

Answered by AI

How many people is this experiment enrolling?

"Affirmative. According to clinicaltrials.gov, this medical experiment is still recruiting patients as of October 18th 2022. It was first made available on August 31st, and so far 84 participants have been recruited from a single site."

Answered by AI

Does this investigation involve senior citizens as participants?

"Per the rules for this medical experiment, participants must be over 18 years old and no older than 85."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Erector Spinae Block for Spine Surgery
Christina Jeng 2022. "Erector Spinae Block for Spine Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05417113.
~5 spots leftby Apr 2025
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