Recruiting

Ropivacaine & Dexmedetomidine

Sponsor:

University Hospitals Cleveland Medical Center

Code:

NCT07174440

Conditions

Pain

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Ropivacaine (Epidural analgesia)

Dexmedetomidine

Iohexol

QST Procedure

Study Details

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 ID

NCT07174440

Start date

Sep 15, 2025

Status verified date

Mar, 2026

Completion date

Jan 25, 2027

Anticipated

Primary completion date

Jan 25, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

32 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Spinal Surgery Participants

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

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

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

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.

QST Procedure

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

Primary outcome measure

  • Verbal pain score as measured by the numerical rating scale (NRS) [ Time Frame: 12 hours after surgery ]

Central Contacts and Locations

Central contacts

Sena Ulucay, MD

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

Locations

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Ayse Ulucay, MD

216-844-3771Ayse.Ulucay@UHhospitals.org

More Information

Sponsor

University Hospitals Cleveland Medical Center

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Keywords

  • Spinal surgery
  • ESP block

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center on 2026-03-11.