Erector Spinae Plane Block vs Local Infiltration Following Fusion Surgery

Launched by RASHMI MUELLER · Dec 28, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating two different methods to manage pain after spinal fusion surgery, which is a common procedure to treat issues like degenerative disc disease. One group of participants will receive an erector spinae block, a type of regional anesthesia, before their surgery begins. Another group will get a local anesthetic injected at the end of the surgery. There is also a control group that will have the surgery under general anesthesia without any additional pain relief methods. The study will look at how well these methods control pain, how much medication participants need afterward, and any effects on inflammation in the body.

To participate in this trial, individuals should be between 18 and 80 years old, scheduled for a specific type of non-emergency spinal surgery, and should not be using opioids regularly. Participants can expect to receive either of the pain management techniques or standard care during their surgery. The study aims to find the best way to help patients recover comfortably from surgery, which is important for overall health and well-being. If you or a loved one are considering joining this trial, it’s a good opportunity to contribute to understanding pain management in surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria for all groups:
• • 1. Age: Greater than 18 years but less than 80
• • 2. Surgical procedure: 1 to 2 level thoraco-lumbar fusion between T8 and S2; non-emergent surgery
• • 3. Opioid naive (less than 6 oxycodone/day or 30 mg oxycodone equivalent)
• • 4. No contraindication to local anesthetics or regional procedures.
• Exclusion Criteria for all groups:
• • 1. Emergency surgery
• • 2. Allergy to study medications
• • 3. BMI less than 20 or greater than 50
• • 4. Major liver or kidney dysfunction or other pre-existing major organ dysfunction
• • 5. Revision surgery
• • 6. Opioid tolerant (60 mg morphine equivalents/day for 1 week) or narcotic dependence (opioid intake morphine equivalent greater than10 mg/day for more than 3 months)
• • 7. Other sources of chronic pain (e.g. fibromyalgia)
• • 8. Patients with associated significant central nervous system (CNS) or respiratory disease (home oxygen use)
• • 9. Pre-operative neurological deficits
• • 10. Co-existing hematological disorders or deranged coagulation parameters
• • 11. Significant psychiatric illnesses that impedes the subject's ability to provide informed consent
• • 12. Language barrier
• • 13. Vulnerable population (e.g. prisoners)
• • 14. Pregnant females
• • 15. History of recent myocardial infarction
• • 16. History of recent cardiac stent procedure (within 3 months)
• • 17. Cardiac ejection fraction \< 30%