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Search / Trial NCT06107660

Utility of Exparel Based ESP Blocks in Elective Posterior Spine Fusion

Launched by HARTFORD HOSPITAL · Oct 25, 2023

Trial Information

Current as of July 27, 2025

Not yet recruiting

Keywords

Erector Spinae Block Lumbar Spine Bupivacaine Exparel

ClinConnect Summary

This clinical trial is studying two different medications to help manage pain after lower back surgery, specifically a procedure called spine fusion. Researchers want to find out if a newer medication called liposomal bupivacaine can help patients use fewer opioids after surgery compared to the standard medication, which is bupivacaine combined with stabilizing agents. They are also interested in whether patients feel less pain and are more satisfied with their surgery when they receive the new medication.

To participate in this trial, individuals must be undergoing a specific type of spine surgery for certain back problems and should not be on narcotic pain medications or have some other medical conditions such as neurological issues or chronic pain disorders. Participants will be randomly assigned to receive either liposomal bupivacaine or the standard medication, but they will continue to receive the usual care provided at the hospital without needing to fill out extra forms. This study is not yet recruiting, but it aims to help improve pain management options for future patients undergoing spine surgery.

Gender

ALL

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.

About Hartford Hospital

Hartford Hospital is a leading academic medical center affiliated with the University of Connecticut, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical research, the hospital focuses on a diverse range of therapeutic areas, aiming to improve patient outcomes and enhance treatment methodologies. With a robust infrastructure and a multidisciplinary team of experts, Hartford Hospital fosters a collaborative environment that supports the development and implementation of cutting-edge medical interventions, ultimately contributing to the advancement of medical science and patient care.

Locations

Patients applied

0 patients applied

Trial Officials

Heeren Makanji, MD

Principal Investigator

Hartford HealthCare

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported