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NCT06350981

Analgesic Requirement for Post-Operative Pain Control in TLIP Interbody Fusion

Enrolling by Invitation
PHASE2Ages 18+InterventionalTreatment
Foundation for Orthopaedic Research and Education
~76 participants
Updated 2025-02-25 on ClinicalTrials.gov
What's tested:ExparelBupivacain

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over 0-72 hours post-operatively

Conditions

Back Pain
Surgery-Complications
Narcotic Use
Physical Stress
Post Operative Pain

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Back Pain

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • John Small, MD · PRINCIPAL_INVESTIGATOR · Florida Orthopaedic Institute

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Patients 18 years or older,
Patients admitted to AHC for 1-3 level TLIF,
Patients who have given written informed consent,
BMI between 18-35 kg/m2,

Exclusion

Patients with known allergic reactions to standard of care analgesics,
Female patients who are pregnant
Patients with any previous lumbar spine instrumented surgery,
Chronic opioid use within 30 days prior to randomization that exceeds average ≥30 oral morphine equivalents/day,
Patients with known allergy to local anesthetics,
Patients with known or suspected to have neuromuscular disorders impairing neuromuscular blockade (e.g. myasthenia gravis).

What this trial 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.0-72 hours post-operatively

    Data will be analyzed by randomized treatment group to determine efficacy. Superiority of treatment with EXPAREL compared with Bupivacaine hydrochloride will be determined using linear regression adjusting for Pain Catastrophizing Scale with treatment as main effect for the primary efficacy endpoint of area under the curve of the Numerical rating scale pain intensity scores from 0 to 72 hours post-surgery.