Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT06107660
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
80 Years
Study:
NCT06107660
Study Brief:
Protocol Section:
NCT06107660