Pain Management for Postoperative Pain

Recruiting in Palo Alto (17 mi)

John M. Small, MD | Florida Orthopaedic ...

Overseen byJohn Small, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Foundation for Orthopaedic Research and Education

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The goal of this clinical trail is to to compare the efficacy of thoracolumbar interfascial plane block with Exparel vs with standard of care 0.25% Bupivacaine HCl in patients undergoing 1-3 level elective transforaminal lumbar interbody fusion. The investigators hypothesize that thoracolumbar interfascial plane block with Exparel will outperform standard of care (supplemented with interfascial plane block of 0.25% Bupivacaine HCl) with regards to pain reduction, narcotic use, length of hospital stay, time to mobilization with physical therapy, narcotic usage in the hospital, and post operative pain scores.

Research Team

John Small, MD

Principal Investigator

Florida Orthopaedic Institute

Eligibility Criteria

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.

Inclusion Criteria

I am admitted for a 1-3 level spinal fusion surgery.

I am 18 years old or older.

Patients who have given written informed consent

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Exclusion Criteria

I am currently pregnant.

Patients with known allergy to local anesthetics

Patients with known allergic reactions to standard of care analgesics

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Treatment Details

Interventions

Bupivacaine (Local Anesthetic)
Exparel (Local Anesthetic)

Trial OverviewThe 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.

Participant Groups

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.