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

NCT07174440 | Recruiting

• 1 other identifier: STUDY20241500
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

Spinal surgery; ESP block

Outcome Measures

Primary Outcomes (1)

• Verbal pain score as measured by the numerical rating scale (NRS)

  NRS rates pain intensity on a scale of 0 to 10, with 0 being no pain and 10 being worst possible pain.

  12 hours after surgery

Secondary Outcomes (5)

• Patient-reported outcome to assess the quality of recovery as measured by the QoR-15

  Daily during hospital stay, up to 4 days

• Time to oral food intake as measured by patient report

  Daily during hospital stay, up to 4 days

• Time to ambulation as measured by patient report

  Daily during hospital stay, up to 4 days.

• Length of hospital stay as measured by medical record review

  Up to 5 days

• Number of intraoperative events as measured by medical record review.

  Up to 12 hours after surgery

Study Arms (1)

Spinal Surgery Participants

EXPERIMENTAL

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

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

Interventions

Ropivacaine (Epidural analgesia) 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

Spinal Surgery Participants

Dexmedetomidine 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

Spinal Surgery Participants

Iohexol 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.

Spinal Surgery Participants

QST Procedure PROCEDURE

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

Spinal Surgery Participants

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Ropivacaine; Analgesia, Epidural; Dexmedetomidine; Iohexol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Analgesia; Anesthesia and Analgesia; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Salim Hayek, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sena Ulucay, MD

CONTACT

216-84-3771; Ayse.Ulucay@UHhospitals.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice Chair for Clinical Research, Department of Anesthesiology

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 16, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): January 25, 2027
• Study Completion (Estimated): January 25, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)