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

Not Applicable

Recruiting

• Conditions: Pain
• Interventions: Drug: Ropivacaine (Epidural analgesia); Drug: Dexmedetomidine; Drug: Iohexol; Procedure: QST Procedure

• Registration Number: NCT07174440
• Lead Sponsor: University Hospitals Cleveland Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-12
• Study First Submitted QC: 2025-09-12
• Study Start: 2025-09-15
• Last Update Submitted: 2025-09-15
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-19
• Primary Completion: 2026-01-25
• Study Completion: 2026-01-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States