Opioid-free Analgesia for Posterior Spinal Fusion Surgery Using Erector Spinae Plane (ESP) Blocks in a Multimodal Anesthetic Regimen.
Ki Jinn Chin, Stephen Lewis
https://pubmed.ncbi.nlm.nih.gov/30180150Actively Recruiting
Phase 4
Age: 18Years - 80Years
All Genders
ID05029726
Randomized, Placebo-controlled Trial of Erector Spinae Plane Blocks for Pain Management in Minimally Invasive Lumbar Spine Surgery
Led by John O'Toole · Updated on 2026-02-17
125
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Opioid overuse is a major public health issue in the United States, especially for patients with chronic pain from degenerative spine conditions. This trial investigates whether adding regional analgesic techniques can reduce the need for opioids after minimally invasive lumbar spine surgery. The study focuses on how these methods may lower opioid use and related complications following common lumbar spine procedures. The trial compares two groups: one receiving an erector spinae plane block (ESPB) with bupivacaine, epinephrine, and clonidine before surgery, and a control group receiving a placebo injection of saline using the same technique. ESPB involves ultrasound-guided injection near the spine to provide multi-level pain relief lasting from 4 to 36 hours. The surgeries include minimally invasive decompression and fusion procedures. Participants will be monitored for opioid consumption during their hospital stay and up to 90 days after surgery. Researchers will also assess pain scores, opioid-related complications like urinary retention and delirium, hospital length of stay, and patient-reported pain and function up to six weeks post-operation. The study uses a randomized, placebo-controlled design with detailed follow-up to evaluate the benefits and safety of ESPB in this surgical setting.
CONDITIONS
Brief Title
Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Undergoing one of these procedure types: 2 or more levels of minimally invasive decompression; 1 to 3 levels of minimally invasive transforaminal lumbar interbody fusion; or 1 to 3 levels of anterior or lateral lumbar interbody fusion with posterior instrumentation
- Willing and able to give informed consent
You will not qualify if you...
- Opioid tolerance defined as using more than 30mg morphine milligram equivalents daily
- Having an indwelling pain device like an opioid pump or spinal cord stimulator
- Known allergy to bupivacaine, clonidine, or similar local anesthetics
- Surgery indicated for reasons other than degenerative disease such as tumor, infection, or trauma
- Chronic kidney disease stage 3 or higher, or liver failure
- Active pregnancy
- Mental illness or disease preventing accurate pain evaluation during the perioperative period
- Active Worker's Compensation litigation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to the day of surgery
Participants receive either a regional erector spinae plane block with bupivacaine plus clonidine or a placebo injection of normal saline immediately prior to minimally invasive lumbar spine surgery.
1 preoperative visit (in-person)
Post-operative Follow-up
Duration - Up to 90 days postoperatively
Participants are monitored for pain, opioid consumption, opioid-related complications, and recovery following surgery.
Daily visits during inpatient admission up to 30 days, and follow-up visits at approximately 14, 56, and 90 days post-surgery
Trial Site Locations
Total: 1 location
1
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
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Research Team
B
Bart Jacher
M
Morgan Mulcahy
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Opioid-sparing multimodal analgesia with bilateral bi-level erector spinae plane blocks in scoliosis surgery: a case report of two patients.
Ki Jinn Chin, Michael J Dinsmore, Stephen Lewis...
https://pubmed.ncbi.nlm.nih.gov/31482311The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain.
Mauricio Forero, Sanjib D Adhikary, Hector Lopez...
https://pubmed.ncbi.nlm.nih.gov/27501016Low thoracic erector spinae plane block for perioperative analgesia in lumbosacral spine surgery: a case series.
Josh P Melvin, Rudolph J Schrot, George M Chu...
https://pubmed.ncbi.nlm.nih.gov/29704223Bilateral Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: A Randomized Control Trial.
Swati Singh, Neeraj K Choudhary, Dusu Lalin...
https://pubmed.ncbi.nlm.nih.gov/31033625Efficacy of the Erector Spinae Plane Block for Lumbar Spinal Surgery: A Retrospective Study.
Hironobu Ueshima, Mayumi Inagaki, Tomoaki Toyone...
https://pubmed.ncbi.nlm.nih.gov/30424594Evaluation of adding the Erector spinae plane block to standard anesthetic care in patients undergoing posterior lumbar interbody fusion surgery.
Renee J C van den Broek, Robbin van de Geer, Niek C Schepel...
https://pubmed.ncbi.nlm.nih.gov/33828209Preoperative opioid use and its association with perioperative opioid demand and postoperative opioid independence in patients undergoing spine surgery.
Sheyan J Armaghani, Dennis S Lee, Jesse E Bible...
https://pubmed.ncbi.nlm.nih.gov/25417827Opioid Utilization Following Lumbar Arthrodesis: Trends and Factors Associated With Long-term Use.
Piyush Kalakoti, Nathan R Hendrickson, Nicholas A Bedard...
https://pubmed.ncbi.nlm.nih.gov/30045343