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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal Surgery Participants | Experimental | Participants scheduled for spinal surgery will have ESP block medications administered as per standard care along with contrast dye. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Daily during hospital stay, up to 4 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sena Ulucay, MD | Contact | 216-84-3771 | Ayse.Ulucay@UHhospitals.org |
| Name | Affiliation | Role |
|---|---|---|
| Salim Hayek, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D015360 | Analgesia, Epidural |
| D020927 | Dexmedetomidine |
| D007472 | Iohexol |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| Dexmedetomidine | 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 |
|
| Iohexol | 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 except for iohexol which is used for study purposes. |
|
| QST Procedure | Procedure | The QST procedure (test of buzzing sensation and temperature sensation through pads applied to your skin) to assess the numb areas. |
|
| 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 | Patients will be asked daily if they are walking to the bathroom. | Daily during hospital stay, up to 4 days. |
| Length of hospital stay as measured by medical record review | 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. | Up to 12 hours after surgery |
| D000588 |
| Amines |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014283 | Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |