RecruitingNot ApplicableNCT07174440

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


Sponsor

University Hospitals Cleveland Medical Center

Enrollment

32 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 YearsMax Age: 75 Years

Inclusion Criteria4

  • Age range: Adult patients 21-75 years of age
  • ASA status: I-III
  • Planned lumbar spine fusion involving no more than three levels
  • Ability to ambulate prior to surgery

Exclusion Criteria8

  • Previous lumbar spine surgery
  • Metastatic cancer with involvement of the lumbar spine
  • eGFR < 60 mL/min/1.73m2
  • Active liver disease (hepatitis or cirrhosis)
  • Confirmed allergy to ropivacaine, dexmedetomidine or iohexol
  • Cognitive impairment resulting in inability to rate pain scores
  • Patients receiving 30 mg or more of morphine equivalent daily dosing preoperatively
  • Pregnancy

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Interventions

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

DRUGDexmedetomidine

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

DRUGIohexol

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 except for iohexol which is used for study purposes.

PROCEDUREQST Procedure

The QST procedure (test of buzzing sensation and temperature sensation through pads applied to your skin) to assess the numb areas.


Locations(1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

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NCT07174440


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