Comparing pain relief methods after lumbar fusion surgery
Opioid Usage and Patient Reported Outcome Comparison Following Erector Spinae Plane Block or Subcutaneous Anesthetic in Spinal Fusion Procedures
This study tests whether a new way of giving local anesthesia during lumbar fusion surgery can help patients feel less pain and use fewer opioids compared to the traditional method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Massachusetts, Worcester Academic / other |
| Locations | 1 site (Worcester, Massachusetts) |
| Trial ID | NCT06528288 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of two different methods of administering local anesthesia on postoperative pain and opioid usage in patients undergoing lumbar fusion surgery. It compares the traditional subcutaneous anesthesia technique with the erector spinae plane block (ESPB), which uses fluoroscopic guidance to deliver anesthesia along the back muscles and bones. The study aims to determine if ESPB leads to lower opioid consumption and reduced pain levels as reported by patients. Patient-reported outcomes will be collected to assess the effectiveness of each method.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for one or two level lumbar spinal fusion surgery.
Not a fit: Patients with certain conditions such as fractures, tumors, infections, or those with a high BMI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management and reduced reliance on opioids after lumbar fusion surgery.
How similar studies have performed: Previous studies have shown promising results with the erector spinae plane block technique, suggesting potential benefits in pain management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The individual has signed and dated a study specific informed consent form approved by the Institutional Review Board at UMMHC. * The individual is at least 18 years of age. * The individual is skeletally mature (over the age of 18). * The patient is scheduled for a one or two level lumbar spinal fusion. Exclusion Criteria: * Patients unable to consent for themselves. * Pregnant women. * Non-English speaking subjects. * Prisoners. * Spinal fusion procedures for a diagnosis of fracture, tumor, and/or infection. * Patients who have used greater than 150 morphine milligram equivalents of opioids in the month prior to their operation. * Patients with a body mass index (BMI) of 40 or greater.
Where this trial is running
Worcester, Massachusetts
- UMass Chan Medical School/UMass Memorial Medical Center — Worcester, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Michael Stauff, MD — UMass Chan Medical School
- Study coordinator: Michael P Stauff, MD
- Email: Michael.Stauff@umassmed.edu
- Phone: 508-334-9764
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.