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

University Hospitals (UH) logo

University Hospitals (UH)

Status

Enrolling

Conditions

Pain

Treatments

Drug: Dexmedetomidine
Procedure: QST Procedure
Drug: Ropivacaine (Epidural analgesia)
Drug: Iohexol

Study type

Interventional

Funder types

Other

Identifiers

NCT07174440
STUDY20241500

Details and patient eligibility

About

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.

Enrollment

32 estimated patients

Sex

All

Ages

21 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • 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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

32 participants in 1 patient group

Spinal Surgery Participants
Experimental group
Description:
Participants scheduled for spinal surgery will have ESP block medications administered as per standard care along with contrast dye.
Treatment:
Drug: Iohexol
Drug: Ropivacaine (Epidural analgesia)
Procedure: QST Procedure
Drug: Dexmedetomidine

Trial contacts and locations

1

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Central trial contact

Sena Ulucay, MD

Data sourced from clinicaltrials.gov

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