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

NCT07174440 — Not applicable, Recruiting, 32 participants, University Hospitals Cleveland Medical Center

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

Registry	NCT07174440
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, prevention
Enrollment	32 (Estimated)
Sponsor	University Hospitals Cleveland Medical Center (Other)
Conditions	Pain
Interventions	Ropivacaine (Epidural analgesia), Dexmedetomidine, Iohexol, QST Procedure (Drug, procedure)
Dates	start 2025-09-15, primary completion 2027-01-25 (estimated), completion 2027-01-25 (estimated), first posted 2025-09-16, last updated 2026-03-11
Locations	1 site in United States

-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.

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+Arms and interventions

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

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.

+Outcome measures

Primary outcomes

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

Patient-reported outcome to assess the quality of recovery as measured by the QoR-15 [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.
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.]: Patients will be asked daily if they are walking to the bathroom.
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]: Events include: hypotension, tachycardia, need for additional opioids beyond the study limit, and blood loss.

+Eligibility

Sex: All, ages: 21 Years to 75 Years

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

+Locations (1)

Facility	City	Country	Status
University Hospitals Cleveland Medical Center	Cleveland, Ohio	United States	Recruiting

+Investigators

Salim Hayek, MD, Principal investigator, University Hospitals Cleveland Medical Center