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The purpose of this study is to retrospectively compare perioperative pain relief and safety in pediatric patients who have received a femoral nerve block with varying concentrations of local anesthetic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Femoral Nerve Blocks | Patients who receive ropivacaine or bupivacaine during femoral nerve block. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Femoral nerve block with ropivacaine or bupivacaine | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Local Anesthetic Injected for Femoral Nerve Block | length of surgery | |
| Total mg of Local Anesthetic Injected for Femoral Nerve Block | length of surgery | |
| Intraoperative Tylenol Administered | Amount of Tylenol administered based on if got ropivacaine or bupivacaine femeral nerve block. | length of surgery |
| Post-operative Opioids Administered | Amount of opioid consumption in the post operative anesthesia care unit depending on if the patient received femoral nerve block with ropivacaine or bupivacaine | in PACU (1 hr post-op) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Discharge From PACU | Conclusion of surgery until admission to assigned unit or to phase, an expected average of 1 hour | |
| Post-operative Pain Scale Using FLACC | The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have undergone anesthesia and received a femoral nerve block at Nationwide Children'ts Hospital from 2010-2015 utilizing our EMR - PICIS.
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| Name | Affiliation | Role |
|---|---|---|
| Giorgio Veneziano, MD | Nationwide Children's Hospital | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Femoral Nerve Blocks | Patients who receive ropivacaine or bupivacaine during femoral nerve block. Femoral nerve block with ropivacaine or bupivacaine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Femoral Nerve Blocks | Patients who receive ropivacaine or bupivacaine during femoral nerve block. Femoral nerve block with ropivacaine or bupivacaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Concentration of Local Anesthetic Injected for Femoral Nerve Block | Posted | Count of Participants | Participants | length of surgery |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Femoral Nerve Blocks | Patients who receive ropivacaine or bupivacaine during femoral nerve block. Femoral nerve block with ropivacaine or bupivacaine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Coordinator | Nationwide Children's Hospital | 6147222997 | heather.dellinger@nationwidechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 21, 2015 | Feb 15, 2018 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| 1 hour post-op |
| Post-operative Pain Scale Using VAS | The visual analogue scale (VAS) for pain is a validated, subjective measure where scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." | 1 hour post-op |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Total mg of Local Anesthetic Injected for Femoral Nerve Block | Posted | Median | Inter-Quartile Range | ml/kg | length of surgery |
|
|
|
| Primary | Intraoperative Tylenol Administered | Amount of Tylenol administered based on if got ropivacaine or bupivacaine femeral nerve block. | Posted | Number | percentage of participants | length of surgery |
|
|
|
| Primary | Post-operative Opioids Administered | Amount of opioid consumption in the post operative anesthesia care unit depending on if the patient received femoral nerve block with ropivacaine or bupivacaine | Posted | Median | Inter-Quartile Range | mg/kg | in PACU (1 hr post-op) |
|
|
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| Secondary | Time to Discharge From PACU | One patient was excluded from analysis of time to PACU discharge due to a missing PACU arrival time. | Posted | Median | Inter-Quartile Range | minutes | Conclusion of surgery until admission to assigned unit or to phase, an expected average of 1 hour |
|
|
|
| Secondary | Post-operative Pain Scale Using FLACC | The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. | 63 of the 281 total subjects had their pain assessed using the FLACC pain scale. | Posted | Median | Inter-Quartile Range | units on a scale | 1 hour post-op |
|
|
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| Secondary | Post-operative Pain Scale Using VAS | The visual analogue scale (VAS) for pain is a validated, subjective measure where scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." | 197 out of the total 281 subjects had their pain assessed using VAS. | Posted | Median | Inter-Quartile Range | units on a scale | 1 hour post-op |
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| 0 |
| 281 |
| 0 |
| 281 |
| 0 |
| 281 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
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| Measurements |
|---|
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| Title | Measurements |
|---|---|
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