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NCT Number: NCT07174440

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

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.

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Key information

Conditions

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

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location status: Recruiting

Location contact

Ayse Ulucay, MD

CONTACT

[email protected]

216-844-3771

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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.

QST Procedure

Procedure

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

Primary outcomes

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

    Time frame: 12 hours after surgery

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

Secondary outcomes

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

    Time frame: Daily during hospital stay, up to 4 days

    Concise, 15-item questionnaire that covers domains like physical comfort, emotional state, psychological support, physical independence, and pain. A higher QoR-15 score indicates a better quality of recovery.

  2. Time to oral food intake as measured by patient report

    Time frame: Daily during hospital stay, up to 4 days

  3. Time to ambulation as measured by patient report

    Time frame: Daily during hospital stay, up to 4 days.

    Patients will be asked daily if they are walking to the bathroom.

  4. Length of hospital stay as measured by medical record review

    Time frame: Up to 5 days

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

    Time frame: Up to 12 hours after surgery

    Events include: hypotension, tachycardia, need for additional opioids beyond the study limit, and blood loss.

Study contacts

Contact information is provided by the study sponsor or research team.

Sena Ulucay, MD

CONTACT

[email protected]

216-84-3771

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 16, 2025
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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