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

StatusEnrolling by Invitation
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jan 1, 2026 → Jan 1, 2027
See other at-risk trials from Foundation for Orthopaedic Research and Education

Record History

  1. Notable Primary completion pushed from Jan 1, 2026 to Jan 1, 2027
    • Study completion pushed from Mar 1, 2026 to Mar 1, 2027
    v4
  2. Notable Primary completion date: Jan 1, 2025 to Jan 1, 2026
    • Study completion date: Mar 1, 2025 to Mar 1, 2026
    v3
  3. Notable Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Apr 1, 2024 to Apr 30, 2024
    • Site contact updated
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06350981
Lead Sponsor Foundation for Orthopaedic Research and Education
Collaborators: Pacira Pharmaceuticals, Inc
Conditions
(from sponsor)
Back Pain, Surgery-Complications, Narcotic Use, Physical Stress, Post Operative Pain
Related terms Back Pain, Postoperative Pain
Enrollment 76 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov