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RecruitingNCT07174440

Contrast and Anesthetic Level With Lumbar Erector Spinae Plan (ESP) Block

Erector Spinae Plane Block in Patients Undergoing Lumbar Spine Fusion Surgery: Iohexol Spread, Extent of Block and Efficacy

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
32 (estimated)
Sponsor
University Hospitals Cleveland Medical Center · Academic / Other
Sex
All
Age
21 Years – 75 Years
Healthy volunteers
Not accepted

Summary

As per usual care for spine surgery, participants will have their back cleaned with alcohol and a needle will be placed using ultrasound for the ESP block. Through the needle, a small catheter will be placed in the participants back and the needle removed. Approximately one hour prior to the start of surgery, a numbing medication (ropivacaine, similar to Novocaine) in combination with dexmedetomidine (a pain medicine that is used in nerve block and that is not a narcotic) and contrast dye (iohexol) will be injected through the catheter. Participants will then go through the QST procedure (test of buzzing sensation and temperature sensation through pads applied to their skin) to assess the numb areas and then head to the operating room. In the operating room, the catheter will be removed after the surgeon obtains baseline CT scan images of the spine. Once surgery is completed, investigators will record pain scores over the next four days in the hospital and the amount of pain medication needed for controlling pain related to the surgery.

Conditions

Interventions

TypeNameDescription
DRUGRopivacaine (Epidural analgesia)The block solution will consist of 1% ropivacaine 3 mg/Kg ideal body weight (IBW) mixed with dexmedetomidine 0.5 mcg/Kg IBW and diluted with 10 mL iohexol 300 mg/mL and normal saline for a total volume of 40 mL. All medications used are standard of care
DRUGDexmedetomidineThe block solution will consist of 1% ropivacaine 3 mg/Kg ideal body weight (IBW) mixed with dexmedetomidine 0.5 mcg/Kg IBW and diluted with 10 mL iohexol 300 mg/mL and normal saline for a total volume of 40 mL. All medications used are standard of care
DRUGIohexolThe block solution will consist of 1% ropivacaine 3 mg/Kg ideal body weight (IBW) mixed with dexmedetomidine 0.5 mcg/Kg IBW and diluted with 10 mL iohexol 300 mg/mL and normal saline for a total volume of 40 mL. All medications used are standard of care except for iohexol which is used for study purposes.
PROCEDUREQST ProcedureThe QST procedure (test of buzzing sensation and temperature sensation through pads applied to your skin) to assess the numb areas.

Timeline

Start date
2025-09-15
Primary completion
2027-01-25
Completion
2027-01-25
First posted
2025-09-16
Last updated
2026-03-11

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07174440. Inclusion in this directory is not an endorsement.