Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

February 11, 2026 updated by: John O'Toole

Randomized, Placebo-controlled Trial of Erector Spinae Plane Blocks (ESPB) for Perioperative Pain Management for Minimally Invasive (MIS) Lumbar Spine Surgery

Opioid overuse is a widespread public health crisis in the United States with increasing rates of addiction and overdose deaths from prescription opioids. Reducing the need for opiate analgesics in the post-operative setting has become a high priority in minimizing long-term opioid use in surgical patients. This study will serve to demonstrate the efficacy of the addition of regional analgesic techniques in reducing post-operative opioid requirements in patients undergoing common lumbar spinal surgical procedures.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Opioid abuse and misuse remain a public health crisis in the United States, notably in patients with chronic pain from degenerative spine disease. Perioperative pain management for patients undergoing spinal surgery remains largely reliant on opioid medications, with several known adverse effects including, but not limited to delirium, postoperative urinary retention (POUR), constipation and nausea. These side effects contribute to increased hospital length of stay (LOS) with increased incidence of overall in-hospital complications, perioperative costs, and increased rates of opioid habituation and addiction.

Dependence on prescription opioids has been associated with wide-ranging social and economic consequences including increased opioid overdose resulting in death, growing opioid-related incarcerations, and spiraling opioid-related healthcare cost from treatment of addiction, opioid-related mental health issues, and debilitating chronic pain. Long-term requirements for opioid medications may be associated with the use of higher doses of opioids in the perioperative period for patients undergoing invasive surgery for spinal degenerative conditions. Studies have demonstrated that patients who consume fewer opioids for 30 days after surgery are less likely to progress to become chronic opioid users. Regional analgesic techniques have shown promise in decreasing post-operative pain and opioid requirements in thoracic and abdominal surgery but difficulties with post-operative neurological assessments have limited their use in spinal surgery. Inter-fascial plane blocks, however, have emerged as a safe and potentially useful regional analgesic technique to mitigate the pain-inducing effects of posterior spine surgery.

Erector Spinae Plane Blocks (ESPBs), specifically, involve ultra-sound guided injection of local anesthetic (LA) posteriorly beneath the erector spinae muscles resulting in longitudinal and ventrolateral spread of the anesthetic into the paravertebral space where the ventral and dorsal rami of the spinal nerves are located thereby inducing a multi-level analgesic effect. Depending upon the LA used, this effect may last for 4 to 36 hours.

The proposed study will examine the efficacy of preoperative ESPBs in reducing post-operative opioid utilization and its associated complications specifically after minimally invasive (MIS) lumbar spine surgery including both decompressive and instrumented fusion procedures. The guiding principle of MIS spine surgery is reduction of iatrogenic injury by utilizing muscle dilating approaches and tubular retractors rather than conventional open, subperiosteal muscle stripping techniques. The latter typically results in muscle denervation and devascularization as well as postoperative muscle atrophy and dead space creation that increase postoperative pain, muscle dysfunction, prolonged recovery times and complications. Since MIS spinal surgical procedures preserve normal paraspinal musculature compared to open surgery, the magnitude of effect of ESPBs may actually be more pronounced in this population.

The investigators hypothesize that by conducting this investigation within the rigor of a double-blinded, randomized placebo-controlled clinical trial, the results will definitively demonstrate that the addition of regional analgesia in the form of ESPB during MIS lumbar spine surgery will 1) reduce post-operative opioid consumption and 2) reduce opioid-related complications and hospital LOS but 3) have no adverse effects on postoperative pain control.

Study Type

Interventional

Enrollment (Estimated)

125

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • John O'Toole, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigational
Patients will undergo regional ESPB with bupivacaine plus clonidine in the holding area of the OR immediately prior to surgery. 30mL of 0.25% bupivacaine/1:200,000 epinephrine/50mcg clonidine will be administered bilaterally (total 60ml) to the lumbar paraspinal erector spine plane using ultrasound-guidance.
Drug: Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine
Bupivacaine-Epinephrine 0.25%-1:200,000 plus clonidine 50 micrograms in 30cc syringes administered as ESPB
Placebo Comparator: Control
Patients will receive a placebo injection of normal saline via the same ESPB technique. 30ml of normal saline will be administered bilaterally (total 60ml) to the lumbar paraspinal erector spine plane using ultrasound-guidance.
Drug: normal saline
normal saline in 30cc syringes administered using ESPB technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inpatient opioid consumption
Time Frame: Every 1 day during inpatient admission up to 30 days
Mean per day inpatient opioid consumption in morphine milligram equivalents (MME)
Every 1 day during inpatient admission up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-discharge opioid consumption
Time Frame: 14 days (+/- 7days) ,56 days (+/- 14 days) and 90 days (+/- 19) postoperatively
Total and per day mean postoperative opioid consumption after hospital discharge in MME as recorded in medication diary by patients
14 days (+/- 7days) ,56 days (+/- 14 days) and 90 days (+/- 19) postoperatively
Postoperative opioid prescriptions filled
Time Frame: From hospital discharge to 90 days postoperatively
• Total MMEs of opioid prescriptions filled as found on the Illinois Prescription Monitoring Program website
From hospital discharge to 90 days postoperatively
Length of hospital stay
Time Frame: From time of surgery to time discharge criteria met in hours, up to 2160 hours
Duration of hospital stay postoperatively measured in days as determined by the time at which each patient met discharge criteria
From time of surgery to time discharge criteria met in hours, up to 2160 hours
Postoperative Urinary Retention (POUR)
Time Frame: Immediately post-surgery to discharge, up to 90 days
Incidence of POUR measured as proportion of inpatient hospital days demonstrating the need for straight catheterization or foley placement
Immediately post-surgery to discharge, up to 90 days
Post-operative delirium
Time Frame: Immediately post-surgery to discharge
Incidence of post-operative delirium as measured by the need for placement of physical restraints
Immediately post-surgery to discharge
Post-operative delirium
Time Frame: Immediately post-surgery to discharge, up to 90 days
Incidence of post-operative delirium as measured by the administration of new anti-psychotic medications
Immediately post-surgery to discharge, up to 90 days
Postoperative pain scores
Time Frame: Every 1 day during inpatient admission up to 30 days
Mean daily VAS (visual analog scale) pain scores recorded in the electronic medical record (EMR)
Every 1 day during inpatient admission up to 30 days
Patient-reported pain and functional outcomes
Time Frame: From baseline preoperative values to 6 week post-operative values
Change in Visual Analog Scale (VAS) for pain in the back and leg (0-10 with 10 being worst)
From baseline preoperative values to 6 week post-operative values
Patient-reported pain and functional outcomes
Time Frame: From baseline preoperative values to 6 week post-operative values
Change in Oswestry Disability Index (ODI; 0 to 100 with 100 being worst)
From baseline preoperative values to 6 week post-operative values
Patient-reported pain and functional outcomes
Time Frame: From baseline preoperative values to 6 week post-operative values
Change in Short Form 12/6D (SF-12/6D; 0 to 100 with 0 being worst)
From baseline preoperative values to 6 week post-operative values
Peri-operative complications
Time Frame: Time of surgery to 6 weeks postoperative
Prospectively documented medical and surgical complications/adverse events (AEs) including rates of readmission or reoperation for AEs
Time of surgery to 6 weeks postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

John O'Toole

Investigators

  • Principal Investigator: John O'Toole, MD, Rush University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

August 14, 2021

First Submitted That Met QC Criteria

August 25, 2021

First Posted (Actual)

August 31, 2021

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORA20050502

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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