Contrast and Anesthetic Level With Lumbar Erector Spinae Plan (ESP) Block
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ropivacaine (Epidural analgesia), Dexmedetomidine, Iohexol, QST Procedure.
- Who it may be relevant to
- Registry conditions: Pain. Basic parameters: 21 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Erector Spinae Plane Block in Patients Undergoing Lumbar Spine Fusion Surgery: Iohexol Spread, Extent of Block and Efficacy
Overview
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.
Interventions
- Drug 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 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 - Drug 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. - Procedure 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 measures
- Verbal pain score as measured by the numerical rating scale (NRS) [Time frame: 12 hours after surgery]
Secondary outcome measures (5)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University Hospitals Cleveland Medical Center — Cleveland
Identifiers
NCT: NCT07174440 · STUDY20241500