| Primary | Number of Patients Who Receive Bilateral, Pre-incision ESPB | number who receive the intervention and complete all assessments | | Posted | | Count of Participants | | Participants | | through study completion, an average of 1 year | | | | ID | Title | Description |
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| OG000 | ESPB With Bupivacaine and Dexamethasone | 12 pediatric spinal fusion surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.25% bupivacaine with 2mg preservative free dexamethasone with a maximum of 30 mL total per side, depending on the patient's weight. Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone: Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone is a corticosteroid that reduces inflammation. | | OG001 | No ESPB | 12 pediatric spinal fusion surgery patients will be randomized to not receive an intraoperative ultrasound-guided bilateral ESPB. These patients will still receive the standard anesthesia regimen during and after surgery. No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone): Patients who are randomized to this group will not receive a bilateral erector spinae plane block |
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| Secondary | Rate of Recruitment | Number enrolled and allocated to specific group | | Posted | | Count of Participants | | Participants | | through study completion, an average of 1 year | | | | ID | Title | Description |
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| OG000 | ESPB With Bupivacaine and Dexamethasone | 12 pediatric spinal fusion surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.25% bupivacaine with 2mg preservative free dexamethasone with a maximum of 30 mL total per side, depending on the patient's weight. Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone: Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone is a corticosteroid that reduces inflammation. | | OG001 | No ESPB | 12 pediatric spinal fusion surgery patients will be randomized to not receive an intraoperative ultrasound-guided bilateral ESPB. These patients will still receive the standard anesthesia regimen during and after surgery. No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone): Patients who are randomized to this group will not receive a bilateral erector spinae plane block |
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| Secondary | Blinding Assessment | Based on Bang's Blinding Index. Patients' ability to determine whether or not they received the ESPB. The success of patient blinding in each group will be quantified using the Bang Blinding Index which ranges from -1 to 1. Scores closest to 0 indicate a less likelihood that patients were able to guess which group they were randomized into. A score of 1 or -1 means that patients were able to guess which group they were in or guessed the wrong group, respectively. This value is obtained by asking patients which group they believe they were randomly assigned to. | | Posted | | Mean | 95% Confidence Interval | score on a scale | | 24 hours after surgery | | | | ID | Title | Description |
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| OG000 | ESPB With Bupivacaine and Dexamethasone | 12 pediatric spinal fusion surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.25% bupivacaine with 2mg preservative free dexamethasone with a maximum of 30 mL total per side, depending on the patient's weight. Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone: Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone is a corticosteroid that reduces inflammation. | | OG001 | No ESPB | 12 pediatric spinal fusion surgery patients will be randomized to not receive an intraoperative ultrasound-guided bilateral ESPB. These patients will still receive the standard anesthesia regimen during and after surgery. No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone): Patients who are randomized to this group will not receive a bilateral erector spinae plane block |
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| Secondary | Number of Participants Unable to Receive ESPB Block. | Number of participants who were randomized to receive the ESPB block, but were unable to receive the block. The no ESPB group were randomized not to get the ESPB block, leading to 0 instances of missed ESPB block. | | Posted | | Count of Participants | | Participants | | Holding area, Post-Anesthesia Care Unit (PACU) (hour 0), hour 8, 12, and 24 hours after surgery | | | | ID | Title | Description |
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| OG000 | ESPB With Bupivacaine and Dexamethasone | 12 pediatric spinal fusion surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.25% bupivacaine with 2mg preservative free dexamethasone with a maximum of 30 mL total per side, depending on the patient's weight. Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone: Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone is a corticosteroid that reduces inflammation. | | OG001 | No ESPB | 12 pediatric spinal fusion surgery patients will be randomized to not receive an intraoperative ultrasound-guided bilateral ESPB. These patients will still receive the standard anesthesia regimen during and after surgery. No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone): Patients who are randomized to this group will not receive a bilateral erector spinae plane block |
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| Secondary | Attrition | Number of patients who enroll but do not receive the intervention and/or study assessments. | | Posted | | Number | | participants | | through study completion, an average of 1 year | | | | ID | Title | Description |
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| OG000 | ESPB With Bupivacaine and Dexamethasone | 12 pediatric spinal fusion surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.25% bupivacaine with 2mg preservative free dexamethasone with a maximum of 30 mL total per side, depending on the patient's weight. Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone: Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone is a corticosteroid that reduces inflammation. | | OG001 | No ESPB | 12 pediatric spinal fusion surgery patients will be randomized to not receive an intraoperative ultrasound-guided bilateral ESPB. These patients will still receive the standard anesthesia regimen during and after surgery. No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone): Patients who are randomized to this group will not receive a bilateral erector spinae plane block |
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| Secondary | Incidence of Intra- and Postoperative Complications Attributed to ESPB | Interference with intraoperative neuromonitoring, infection, local anesthetic toxicity, bleeding/hematoma, extremity weakness | | Posted | | Count of Participants | | Participants | | During surgery, PACU (hour 0), hour 8, 12, and 24 hours after surgery | | | | ID | Title | Description |
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| OG000 | ESPB With Bupivacaine and Dexamethasone | 12 pediatric spinal fusion surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.25% bupivacaine with 2mg preservative free dexamethasone with a maximum of 30 mL total per side, depending on the patient's weight. Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone: Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone is a corticosteroid that reduces inflammation. | | OG001 | No ESPB | 12 pediatric spinal fusion surgery patients will be randomized to not receive an intraoperative ultrasound-guided bilateral ESPB. These patients will still receive the standard anesthesia regimen during and after surgery. No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone): Patients who are randomized to this group will not receive a bilateral erector spinae plane block |
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| Secondary | Pain Scores at Rest and Movement | Measured by Numeric Rating Scale (NRS) pain at rest and with movement (0 being no pain and 10 being as bad as you can imagine). NRS was collected for each participant, Mean and Standard Deviations are found below. | | Posted | | Mean | Standard Deviation | score on a scale | | PACU (Post Anesthesia Care Unit, hour 0), hour 8, 12, and 24 hours after surgery, and at hospital discharge (an average of 4 days) | | | | ID | Title | Description |
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| OG000 | ESPB With Bupivacaine and Dexamethasone | 12 pediatric spinal fusion surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.25% bupivacaine with 2mg preservative free dexamethasone with a maximum of 30 mL total per side, depending on the patient's weight. Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone: Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone is a corticosteroid that reduces inflammation. | | OG001 | No ESPB | 12 pediatric spinal fusion surgery patients will be randomized to not receive an intraoperative ultrasound-guided bilateral ESPB. These patients will still receive the standard anesthesia regimen during and after surgery. No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone): Patients who are randomized to this group will not receive a bilateral erector spinae plane block |
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| Secondary | Total Opioid Consumption | Measured in mean oral morphine equivalents (OME) | | Posted | | Mean | Standard Deviation | milligrams | | 0-24 hours after surgery (OME within 24 hrs) | | | | ID | Title | Description |
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| OG000 | ESPB With Bupivacaine and Dexamethasone | 12 pediatric spinal fusion surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.25% bupivacaine with 2mg preservative free dexamethasone with a maximum of 30 mL total per side, depending on the patient's weight. Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone: Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone is a corticosteroid that reduces inflammation. | | OG001 | No ESPB | 12 pediatric spinal fusion surgery patients will be randomized to not receive an intraoperative ultrasound-guided bilateral ESPB. These patients will still receive the standard anesthesia regimen during and after surgery. No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone): Patients who are randomized to this group will not receive a bilateral erector spinae plane block |
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| Secondary | Time to First Opioid Use | Time to pressing Intravenous Patient-Controlled Analgesia (IV PCA) and to requesting first oral opioid | | Posted | | Median | Inter-Quartile Range | minutes | | Up to 24 hours after surgery | | | | ID | Title | Description |
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| OG000 | ESPB With Bupivacaine and Dexamethasone | 12 pediatric spinal fusion surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.25% bupivacaine with 2mg preservative free dexamethasone with a maximum of 30 mL total per side, depending on the patient's weight. Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone: Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone is a corticosteroid that reduces inflammation. | | OG001 | No ESPB | 12 pediatric spinal fusion surgery patients will be randomized to not receive an intraoperative ultrasound-guided bilateral ESPB. These patients will still receive the standard anesthesia regimen during and after surgery. No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone): Patients who are randomized to this group will not receive a bilateral erector spinae plane block |
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| Secondary | Opioid Related Side Effects | Measured by 10 symptom Opioid Related Symptom Distress Scale (ORSDS). Frequency of each symptom within the cohort was assessed. | | Posted | | Number | | participants | | 24 hours after surgery | | | | ID | Title | Description |
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| OG000 | ESPB With Bupivacaine and Dexamethasone | 12 pediatric spinal fusion surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.25% bupivacaine with 2mg preservative free dexamethasone with a maximum of 30 mL total per side, depending on the patient's weight. Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone: Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone is a corticosteroid that reduces inflammation. | | OG001 | No ESPB | 12 pediatric spinal fusion surgery patients will be randomized to not receive an intraoperative ultrasound-guided bilateral ESPB. These patients will still receive the standard anesthesia regimen during and after surgery. No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone): Patients who are randomized to this group will not receive a bilateral erector spinae plane block |
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| Secondary | Patient/Parent Satisfaction With Pain Management | Measured via Likert rating scale (0 being strongly dissatisfied and 10 being strongly satisfied) | | Posted | | Median | Inter-Quartile Range | score on a scale | | At hospital discharge (an average of 4 days) | | | | ID | Title | Description |
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| OG000 | ESPB With Bupivacaine and Dexamethasone | 12 pediatric spinal fusion surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.25% bupivacaine with 2mg preservative free dexamethasone with a maximum of 30 mL total per side, depending on the patient's weight. Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone: Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone is a corticosteroid that reduces inflammation. | | OG001 | No ESPB | 12 pediatric spinal fusion surgery patients will be randomized to not receive an intraoperative ultrasound-guided bilateral ESPB. These patients will still receive the standard anesthesia regimen during and after surgery. No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone): Patients who are randomized to this group will not receive a bilateral erector spinae plane block |
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