Contrast and Anesthetic Level With Lumbar Erector Spinae Plan (ESP) Block
ConditionPain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-75
SponsorUniversity Hospitals Cleveland Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Previous lumbar spine surgery
Metastatic cancer with involvement of the lumbar spine
eGFR < 60 mL/min/1.73m2
Active liver disease (hepatitis or cirrhosis)
Trial design
Design model
Single group
Treatments tested in this trial
Ropivacaine (Epidural analgesia)
DrugThe 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
DrugThe 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
DrugThe 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
Procedure/SurgeryThe QST procedure (test of buzzing sensation and temperature sensation through pads applied to your skin) to assess the numb areas.
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: Spinal Surgery ParticipantsExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
12 hours after surgerySecondary outcomes
1
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.
Time frame
Daily during hospital stay, up to 4 days2
Time to oral food intake as measured by patient report
Time frame
Daily during hospital stay, up to 4 days3
Time to ambulation as measured by patient report
Patients will be asked daily if they are walking to the bathroom.
Time frame
Daily during hospital stay, up to 4 days.4
Length of hospital stay as measured by medical record review
Time frame
Up to 5 daysSponsors and contacts
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Source ClinicalTrials.gov