PainNCT07174440
Contrast and Anesthetic Level With Lumbar Erector Spinae Plan (ESP) Block
A study testing Ropivacaine (Epidural analgesia), Dexmedetomidine and Iohexol in people with Pain, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Pain
- What is being tested?
- Ropivacaine (Epidural analgesia), Dexmedetomidine and Iohexol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2025to 25 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Ayse Ulucay, MD, 216-844-3771, Ayse.Ulucay@UHhospitals.org
About this study
Official title: Erector Spinae Plane Block in Patients Undergoing Lumbar Spine Fusion Surgery: Iohexol Spread, Extent of Block and Efficacy
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
- Being tested
- Ropivacaine (Epidural analgesia), Dexmedetomidine, Iohexol, QST Procedure
- Keywords
- Spinal surgery, ESP block
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
DexmedetomidineDrug
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
IohexolDrug
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 ProcedureProcedure or surgery
The QST procedure (test of buzzing sensation and temperature sensation through pads applied to your skin) to assess the numb areas.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Surgery Participants | Experimental | Participants scheduled for spinal surgery will have ESP block medications administered as per standard care along with contrast dye. Receives: Drug: Ropivacaine (Epidural analgesia); Drug: Dexmedetomidine; Drug: Iohexol; Procedure: QST Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal pain score as measured by the numerical rating scale (NRS)
NRS rates pain intensity on a scale of 0 to 10, with 0 being no pain and 10 being worst possible pain.
Measured: 12 hours after surgery
Secondary outcomes (5)
Patient-reported outcome to assess the quality of recovery as measured by the QoR-15
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.
Measured: Daily during hospital stay, up to 4 days
Time to oral food intake as measured by patient report
Measured: Daily during hospital stay, up to 4 days
Time to ambulation as measured by patient report
Patients will be asked daily if they are walking to the bathroom.
Measured: Daily during hospital stay, up to 4 days.
Length of hospital stay as measured by medical record review
Measured: Up to 5 days
Number of intraoperative events as measured by medical record review.
Events include: hypotension, tachycardia, need for additional opioids beyond the study limit, and blood loss.
Measured: Up to 12 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start15 Sep 2025
- Primary completion25 Jan 2027 (estimated)
- Study completion25 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salim M Hayek, University Hospitals Cleveland Medical Center
- Investigators
- Salim Hayek, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174440
- Sponsor's protocol ID
- STUDY20241500
- Status last verified
- Mar 2026
- First submitted
- 12 Sep 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block in Patients Undergoing Lumbar Spine Fusion Surgery: Iohexol Spread, Extent of Block and Efficacy
- ClinicalTrials.gov ID
- NCT07174440
- Acronym / sponsor ID
- STUDY20241500
- Conditions
- Pain
- Keywords
- Spinal surgery, ESP block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 25 Jan 2027 (estimated)
- Study completion
- 25 Jan 2027 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Surgery Participants | Experimental | Drug: Ropivacaine (Epidural analgesia), Drug: Dexmedetomidine, Drug: Iohexol, Procedure: QST ProcedureParticipants scheduled for spinal surgery will have ESP block medications administered as per standard care along with contrast dye. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Spinal Surgery Participants |
| DexmedetomidineThe 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 | Drug | Spinal Surgery Participants |
| IohexolThe 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. | Drug | Spinal Surgery Participants |
| QST ProcedureThe QST procedure (test of buzzing sensation and temperature sensation through pads applied to your skin) to assess the numb areas. | Procedure or surgery | Spinal Surgery Participants |
Primary outcome
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.
5 secondary outcomes
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
Time to oral food intake as measured by patient report
Time frame: Daily during hospital stay, up to 4 days
Time to ambulation as measured by patient report
Time frame: Daily during hospital stay, up to 4 days.
Length of hospital stay as measured by medical record review
Time frame: Up to 5 days
Number of intraoperative events as measured by medical record review.
Time frame: Up to 12 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Salim Hayek, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine (Epidural analgesia), Dexmedetomidine and Iohexol in people with Pain, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sena Ulucay, MD (216-84-3771, Ayse.Ulucay@UHhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal pain score as measured by the numerical rating scale (NRS) (time frame: 12 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.