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

NCT ID: NCT07174440

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2026-01-25

Brief 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

Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Spinal Surgery Participants

Participants scheduled for spinal surgery will have ESP block medications administered as per standard care along with contrast dye.

Group Type: EXPERIMENTAL

Ropivacaine (Epidural analgesia)

Intervention Type: DRUG

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

Dexmedetomidine

Intervention Type: DRUG

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

Iohexol

Intervention Type: DRUG

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.

QST Procedure

Intervention Type: PROCEDURE

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

Interventions

Ropivacaine (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

Intervention Type: DRUG

Dexmedetomidine

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

Intervention Type: DRUG

Iohexol

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.

Intervention Type: DRUG

QST Procedure

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Salim M Hayek

Professor and Vice Chair for Clinical Research, Department of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Salim Hayek, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sena Ulucay, MD

Role: CONTACT

Ayse.Ulucay@UHhospitals.org

216-84-3771

Facility Contacts

Ayse Ulucay, MD

Role: primary

Ayse.Ulucay@UHhospitals.org

216-844-3771

Other Identifiers

STUDY20241500

Identifier Type: -

Identifier Source: org_study_id