RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-09-15
Study Completion:2026-01-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07174440

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age range: Adult patients 21-75 years of age
  2. * ASA status: I-III
  3. * Planned lumbar spine fusion involving no more than three levels
  4. * Ability to ambulate prior to surgery
  1. * Previous lumbar spine surgery
  2. * Metastatic cancer with involvement of the lumbar spine
  3. * eGFR \< 60 mL/min/1.73m2
  4. * Active liver disease (hepatitis or cirrhosis)
  5. * Confirmed allergy to ropivacaine, dexmedetomidine or iohexol
  6. * Cognitive impairment resulting in inability to rate pain scores
  7. * Patients receiving 30 mg or more of morphine equivalent daily dosing preoperatively
  8. * Pregnancy

Contacts and Locations

Study Contact

Sena Ulucay, MD
CONTACT
216-84-3771
Ayse.Ulucay@UHhospitals.org

Principal Investigator

Salim Hayek, MD
PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center

Study Locations (Sites)

University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States

Collaborators and Investigators

Sponsor: University Hospitals Cleveland Medical Center

  • Salim Hayek, MD, PRINCIPAL_INVESTIGATOR, University Hospitals Cleveland Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-15
Study Completion Date2026-01-25

Study Record Updates

Study Start Date2025-09-15
Study Completion Date2026-01-25

Terms related to this study

Keywords Provided by Researchers

  • Spinal surgery
  • ESP block

Additional Relevant MeSH Terms

  • Pain