Analgesic Requirement for Post-Operative Pain Control in TLIP Interbody Fusion
Enrolling by invitation · Phase 2/Phase 3
Conditions studied: Back Pain, Surgery-Complications, Narcotic Use, Physical Stress, Post Operative Pain
In brief
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 facts
- Study ID
- NCT06350981
- Run by
- Foundation for Orthopaedic Research and Education
- People needed
- 76
- Starts
- 2024-04-30
- Expected to finish
- 2026-03-01
- Last updated by the study team
- 2025-02-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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,
You may not qualify if…
- 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).
Where it is running
- Foundation for Orthopaedic Research and Education — Tampa, Florida, United States
Full record on ClinicalTrials.gov
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