Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

Part of paid clinical trials in Chicago, Illinois.

Sponsor
John O'Toole
Study ID
NCT05029726
Phase
PHASE4
Status
Recruiting
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Conditions

  • Degenerative Disc Disease
  • Degenerative Intervertebral Discs
  • Degenerative Spondylolisthesis
  • Lumbar Disc Herniation
  • Lumbar Radiculopathy
  • Lumbar Spinal Stenosis
  • Lumbar Spine Instability
  • Lumbar Spondylolisthesis
  • Lumbar Spondylosis
  • Synovial Cyst

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine — DRUG
    Bupivacaine-Epinephrine 0.25%-1:200,000 plus clonidine 50 micrograms in 30cc syringes administered as ESPB
  • normal saline — DRUG
    normal saline in 30cc syringes administered using ESPB technique

Study Details

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.

Key Dates

Start date
Feb 1, 2022
Status verified
Feb 2026
Primary completion
Feb 1, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
125 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Inpatient opioid consumption [ Time Frame: Every 1 day during inpatient admission up to 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60612
Bart Jacher
[email protected]
888-352-7874
Morgan Mulcahy
[email protected]
(888) 352-7874
John O'Toole, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By research site
Rush University Medical Center· Chicago, IL

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