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Interim analysis showed no significant difference between study arms.
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The purpose of this study is to prospectively compare post-operative pain relief in pediatric patients undergoing traumatic femur fracture repair who have received either a femoral nerve block with a lateral femoral cutaneous nerve block or a standard anesthetic for analgesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Femoral Nerve Block | Active Comparator | Ropivicaine 0.2% with epinephrine 1:200,000 will be used for patients between 10kg and up to 25kg in weight; ropivicaine 0.5% with epinephrine 1:200,000 will be used for patients greater than or equal to 25kg |
|
| Standard Anesthetic Management | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivicaine | Drug |
|
| |
| Epinephrine |
| Measure | Description | Time Frame |
|---|---|---|
| Post-anesthesia Care Unit (PACU) Pain Scores | Hannallah et al developed the Objective Pain Scale (OPS) to monitor pain in children after surgery. Parameters: (1) systolic blood pressure, (2) crying, (3) movement, (4) agitation (confused, excited), (5) complains of pain (may not be possible in younger children). Interpretation: minimum score: 0; maximum score: 10; maximum score if too young to complain of pain: 8; the higher the score, the greater the degree of pain. | 30 mins after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative End-tidal Isoflurane % | Median end-tidal isoflurane concentration per participant during the average 1 1/2 hr. surgery. | 1 1/2 hr. |
| Time to First Opioid Dose | Median time between PACU discharge and first opioid dose on the ward. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Elsey, MD | Nationwide Children's | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's | Columbus | Ohio | 43205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Femoral Nerve Block | Ropivicaine 0.2% with epinephrine 1:200,000 will be used for patients between 10kg and up to 25kg in weight; ropivicaine 0.5% with epinephrine 1:200,000 will be used for patients greater than or equal to 25kg Ropivicaine |
| FG001 | Standard Anesthetic Management |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Femoral Nerve Block | Ropivicaine 0.2% with epinephrine 1:200,000 will be used for patients between 10kg and up to 25kg in weight; ropivicaine 0.5% with epinephrine 1:200,000 will be used for patients greater than or equal to 25kg Ropivicaine |
| BG001 | Standard Anesthetic Management |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Post-anesthesia Care Unit (PACU) Pain Scores | Hannallah et al developed the Objective Pain Scale (OPS) to monitor pain in children after surgery. Parameters: (1) systolic blood pressure, (2) crying, (3) movement, (4) agitation (confused, excited), (5) complains of pain (may not be possible in younger children). Interpretation: minimum score: 0; maximum score: 10; maximum score if too young to complain of pain: 8; the higher the score, the greater the degree of pain. | Posted | Median | Inter-Quartile Range | pain score | 30 mins after 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 Block | Ropivicaine 0.2% with epinephrine 1:200,000 will be used for patients between 10kg and up to 25kg in weight; ropivicaine 0.5% with epinephrine 1:200,000 will be used for patients greater than or equal to 25kg Ropivicaine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicole Elsey, MD | Nationwide Children's Hospital | 614-722-4200 | Nicole.Elsey@nationwidechildrens.org |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Drug |
|
| From PACU discharge until first opioid dose on the ward, assessed up to 24 hours |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Standard Anesthetic Management |
|
|
| Secondary | Intraoperative End-tidal Isoflurane % | Median end-tidal isoflurane concentration per participant during the average 1 1/2 hr. surgery. | Posted | Median | Inter-Quartile Range | percentage of isoflurane | 1 1/2 hr. |
|
|
|
| Secondary | Time to First Opioid Dose | Median time between PACU discharge and first opioid dose on the ward. | Posted | Median | Inter-Quartile Range | hours | From PACU discharge until first opioid dose on the ward, assessed up to 24 hours |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Standard Anesthetic Management | 0 | 7 | 0 | 7 |
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| D000588 |
| Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |