Using regional anesthesia to reduce opioid use in spine surgery
Randomized, Placebo-controlled Trial of Erector Spinae Plane Blocks (ESPB) for Perioperative Pain Management for Minimally Invasive (MIS) Lumbar Spine Surgery
This study is testing if a special pain management technique can help people having spine surgery use less opioid medication after their operation.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Rush University Medical Center Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05029726 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of regional analgesic techniques, specifically the erector spinae plane block, in minimizing post-operative opioid requirements for patients undergoing minimally invasive lumbar spine surgeries. By administering a combination of bupivacaine, epinephrine, and clonidine, the study seeks to reduce reliance on opioids, thereby addressing the public health crisis of opioid overuse. The research will involve patients aged 18-80 who are scheduled for specific lumbar surgical procedures and will assess pain management outcomes and opioid consumption in the post-operative period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 undergoing specific minimally invasive lumbar spine surgeries.
Not a fit: Patients who are opioid tolerant or have certain contraindications, such as allergies to the study medications, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for opioids after spine surgery, leading to better patient outcomes and lower risks of addiction.
How similar studies have performed: Previous studies have shown promise in using regional analgesic techniques to reduce opioid use in other surgical settings, indicating potential success for this approach in spine surgery.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-80 * Undergoing one of 3 procedure types: 1) 2 or more levels of MIS decompression (e.g., discectomy, foraminotomy, laminectomy); 2) 1-3 levels of MIS transforaminal lumbar interbody fusion (TLIF) (with or without additional levels of MIS decompression for no greater than 3 total operative levels); 3) 1-3 levels of anterior lumbar interbody fusion (ALIF) or MIS lateral lumbar interbody fusion (LLIF) accompanied by posterior percutaneous instrumentation at the same levels * Willing and able to give consent Exclusion Criteria: * Opioid tolerant at the time of the surgical procedure--defined as consuming greater than 30mg of morphine milligram equivalents (MME) daily (https://www.cdc.gov/drugoverdose/prescribing/guideline.html) * Presence of an indwelling pain device (e.g., intrathecal opioid pump, spinal cord stimulator, dorsal root ganglion stimulator) * Known allergy to bupivacaine, clonidine or similar local anesthetics * Indication for surgery other than degenerative disease (e.g., neoplasm, infection, trauma) * Chronic kidney disease (stage 3 or greater), or hepatic failure * Active pregnancy * Disease process or mental illness that would preclude accurate evaluation of pain in the perioperative period * Active Worker's Compensation litigation
Where this trial is running
Chicago, Illinois
- Rush University Medical Center — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: John O'Toole, MD — Rush University Medical Center
- Study coordinator: Bart Jacher
- Email: bartosz_jacher@rush.edu
- Phone: (888) 352-7874
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.