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

Part of paid clinical trials in Tampa, Florida.

Sponsor
Foundation for Orthopaedic Research and Education
Study ID
NCT06350981
Phase
PHASE2/PHASE3
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Exparel — DRUG
    20 mL of EXPAREL 266mg mixed with 10 mL of 0.25% bupivacaine
  • Bupivacain — DRUG
    Standard of care will consist of 0.25% Bupivacaine HCl TLIP injection 30mL

Study Details

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.

Key Dates

Start date
Apr 30, 2024
Status verified
Feb 2025
Primary completion
Jan 1, 2026
Completion
Mar 1, 2026

Study Design

Enrollment
76 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Exparel TLIP Injection
    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.
  • Active Comparator: Bupivicaine HCL TLIP Injection
    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.

Primary Outcome Measure

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. [ Time Frame: 0-72 hours post-operatively ]

Locations (1)

FacilityCityStateZIPSite coordinators
Foundation for Orthopaedic Research and EducationTampaFlorida33607-

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Foundation for Orthopaedic Research and Education· Tampa, FL

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