RecruitingPhase 4NCT05029726

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

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


Sponsor

John O'Toole

Enrollment

125 participants

Start Date

Feb 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether regional (nerve-blocking) anesthesia techniques used during minimally invasive lumbar spine surgery can reduce pain after the procedure, potentially decreasing the need for opioid pain medications. You may be eligible if: - You are 18 to 80 years old - You are scheduled for minimally invasive lumbar spine surgery (such as discectomy, spinal fusion, or decompression) for degenerative disc disease - You are willing and able to give consent You may NOT be eligible if: - You currently use opioid pain medications regularly (more than 30 mg morphine equivalent per day) - You have an implanted pain device (like a spinal cord stimulator or intrathecal pump) - You are allergic to bupivacaine, clonidine, or similar local anesthetics - Your surgery is for a reason other than degenerative disease (such as cancer, infection, or trauma) - You have chronic kidney disease (stage 3 or higher) or liver failure - You are pregnant - You have a condition that would prevent accurate pain assessment after surgery - You are involved in active workers' compensation litigation related to your condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBupivacaine-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

DRUGnormal saline

normal saline in 30cc syringes administered using ESPB technique


Locations(1)

Rush University Medical Center

Chicago, Illinois, United States

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NCT05029726


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