Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery
NCT05029726 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 125
Last updated 2026-02-17
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.
Conditions
- Lumbar Spinal Stenosis
- Lumbar Disc Herniation
- Lumbar Spondylolisthesis
- Lumbar Spondylosis
- Lumbar Radiculopathy
- Lumbar Spine Instability
- Synovial Cyst
- Degenerative Disc Disease
- Degenerative Spondylolisthesis
- Degenerative Intervertebral Discs
Interventions
- 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
- DRUG
-
normal saline
normal saline in 30cc syringes administered using ESPB technique
Sponsors & Collaborators
-
John O'Toole
lead OTHER
Principal Investigators
-
John O'Toole, MD · Rush University Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-01
- Primary Completion
- 2027-02-01
- Completion
- 2027-04-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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