Pain
Conditions
Keywords
Spinal surgery, ESP block
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.
Interventions
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
DRUGDexmedetomidine
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
DRUGIohexol
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.
PROCEDUREQST Procedure
The QST procedure (test of buzzing sensation and temperature sensation through pads applied to your skin) to assess the numb areas.
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Verbal pain score as measured by the numerical rating scale (NRS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported outcome to assess the quality of recovery as measured by the QoR-15 | Daily during hospital stay, up to 4 days | 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 to oral food intake as measured by patient report | Daily during hospital stay, up to 4 days | — |
| Time to ambulation as measured by patient report | Daily during hospital stay, up to 4 days. | Patients will be asked daily if they are walking to the bathroom. |
| Length of hospital stay as measured by medical record review | Up to 5 days | — |
| Number of intraoperative events as measured by medical record review. | Up to 12 hours after surgery | Events include: hypotension, tachycardia, need for additional opioids beyond the study limit, and blood loss. |
Countries
United States
Contacts
CONTACTSena Ulucay, MD
PRINCIPAL_INVESTIGATORSalim Hayek, MD
University Hospitals Cleveland Medical Center
Outcome results
None listed