Utility of Exparel Based ESP Blocks in Elective Posterior Spine Fusion

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

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 bupivacaine, when included in a regional anesthesia technique called the Erector Spinae Plane block (ESPB), reduce opioid use post-operatively compared to the standard medication typically used in an ESPB (bupivacaine with stabilizing agents)?

2. Do patients report lower pain and better satisfaction with their surgery when they receive liposomal bupivacaine in the ESPB compared to those that receive the standard medication?

Participants will be randomized to into two groups one that receives liposomal bupivacaine and one group that receives bupivacaine with stabilizing agents. Other than the randomization all patients will follow current standard of care at our hospital, and will not be asked to complete any additional study forms in addition to forms currently asked of all patients as per standard of care.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hartford Hospital
• Treatments: Bupivacaine

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.