Status:
UNKNOWN
Utility of Exparel Based ESP Blocks in Elective Posterior Spine Fusion
Lead Sponsor:
Hartford Hospital
Conditions:
Spine Fusion
Anesthesia, Local
Eligibility:
All Genders
30-80 years
Phase:
PHASE4
Brief Summary
The goal of this clinical trial is to compare two different medications used to reduce pain during lower back fusion surgery. The main questions this study aims to answer are: 1. Can liposomal bupiva...
Detailed Description
The purpose of this study is to improve pain management for patients having spine fusion surgery. This aim will be achieved by evaluating how well liposomal bupivacaine (LB), an FDA approved numbing m...
Eligibility Criteria
Inclusion
- Lumbar pathology requiring a single or two level elective posterior based (i.e. posterior or transforaminal approach) spine fusion with or without an interbody device.
- Surgical approach through either a midline or paramedian incision
- Primary fusion surgery, previous decompression surgery is acceptable
- American Society of Anesthesiologists (ASA) score of 1,2,or 3.
Exclusion
- Patients currently on narcotic pain medication for pain management
- Patients with a history of illicit drug use
- Patients with neuromuscular disorders or neurological deficits (i.e. post polio or myasthenia gravis)
- Patients confined to a wheelchair for over 6 months
- Patients with fibromyalgia or other chronic pain disorder
- Patient with contraindications for use of the ESP block (i.e. local skin infection over the area of needle entry, or anaphylactic reaction to bupivacaine)
- Non-invasive surgical approaches
- Repeat or revision surgery
- Non-posterior spine surgical approaches (i.e. lateral, oblique, anterior, anterior and posterior approaches)
- Staged procedures
- Adjacent segment surgery
- Patients with a weight less than 40kg to avoid local anesthetic systematic toxicity.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06107660
Start Date
December 1 2023
End Date
December 1 2025
Last Update
October 30 2023
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