Comparing pain control methods after spinal fusion surgery

A Randomized Controlled Trial Comparing the Effect of Erector Spinae Plane Blocks Versus High Volume Local Infiltration Analgesia on Pain, Inflammation and Cognitive Outcomes Following Thoraco-Lumbar Fusion Surgery

This study is testing different ways to manage pain after spinal fusion surgery to see which method helps patients feel better with less need for opioids.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University of Iowa (Academic / other)
• Locations: 1 site (Iowa City, Iowa)
• Trial ID: NCT06199999 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates two different methods for managing postoperative pain in patients undergoing thoraco-lumbar fusion surgery. Participants will be randomly assigned to receive either an erector spinae block (ESP) before surgery, local anesthetic infiltration at the end of the procedure, or general anesthesia alone without regional anesthesia. The study will measure pain levels, opioid usage, and inflammatory markers to evaluate the effectiveness of each pain management approach. Additionally, pre-procedure cognitive assessments will ensure that only eligible patients participate in the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 undergoing non-emergent thoraco-lumbar fusion surgery who are opioid naive.

Not a fit: Patients with emergency surgery needs, significant organ dysfunction, or those who are opioid tolerant or dependent may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management strategies, reducing opioid consumption and enhancing recovery for patients after spinal surgery.

How similar studies have performed: Other studies have shown promising results with regional anesthesia techniques like the erector spinae block, suggesting potential for success in this approach.

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%

Where this trial is running

Iowa City, Iowa

• University of Iowa Health Care Medical Center — Iowa City, Iowa, United States (Recruiting)

Study contacts

• Principal investigator: Rashmi Mueller, MD — University of Iowa
• Study coordinator: Rashmi Mueller, MD

Conditions Postoperative Delirium; Pain, Postoperative; Degenerative Disc Disease