ESP Block in MIS Lumbar Spine Surgery

Study Overview
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Brief Summary
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This is a prospective, randomized controlled trial of patients undergoing minimally invasive transforaminal lumbar interbody fusion. This study will randomize patients into one of two groups: erector spinae plane (ESP) block and no ESP block.

Detailed Description
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Minimally invasive (MIS) spinal surgical procedures such as MIS transforaminal lumbar interbody fusion (TLIF) are being increasingly performed due to reduced morbidity. However, the mainstay for perioperative analgesia after these surgeries remains to be opioid pain medications, which have a number of associated adverse effects such as respiratory depression, hyperalgesia, and opioid habituation. Recently, the erector spinae plane (ESP) block has been introduced as an opioid-sparing regional anesthetic for lumbar spinal surgery with touted benefits including opioid use reduction and improved pain control. The proposed study aims to enroll patients in a double blind randomized controlled trial to undergo MIS TLIF with an ESP block or as conventional control group. Preoperative patient demographics, comorbidities, history of opioid use, and operative details will be obtained. Comprehensive assessment of opioid utilization, postoperative pain, non-opioid pain medication use, opioid-induced complications, time to opioid cessation, time to physical therapy clearance, length of stay, as well as other related outcomes will be performed.

Official Title
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Erector Spinae Plane Block in Patients Undergoing Minimally Invasive Lumbar Spine Surgery: A Randomized Controlled Trial

Conditions
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Patients With Spinal Stenosis Indicated for MIS TLIF

Intervention / Treatment
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* Procedure: Erector spinae plane (ESP) block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 Patients scheduled for MIS TLIF (any level) with the principal investigator ASA 1, 2, 3 Exclusion Criteria: ASA 4 or higher BMI >40 Chronic opioid use (daily use for > 3 months) Revision surgery, any history of previous lumbar spine surgery Allergy to any of the study medications Non-English speaking Chronic renal insufficiency or failure (creatinine >2) or severe hepatic disease (cirrhosis, failure) Pregnancy Any concomitant surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a single-center, prospective, randomized controlled trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESP Block<br>Patients assigned to the ESP Block arm will receive an ESP block prior to the surgery. | Procedure: Erector spinae plane (ESP) block<br>* ESP block is an opioid-sparing regional anesthetic involving bupivacaine and dexamethasone for lumbar spinal surgery with touted benefits including opioid use reduction and improved pain control.<br>|
| No Intervention: Control<br>Patients assigned to the Control group will not receive an ESP block prior to the surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour oral morphine milligram equivalents (OMEs) | The primary outcome of the study will be cumulative opioid use in the first 24 hours postoperatively in oral morphine milligram equivalents (OMEs) (24 hour period from PACU admission to POD1). | 24 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar spine, Erector spinae plane (ESP) block, Transforaminal lumbar interbody fusion (TLIF), Minimally invasive spine surgery, Spinal fusion