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Patients were not willing to be randomized and therefore recruitment could not continue.
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The purpose of this study is to examine the efficacy of the use of Marcaine in femoral nerve blocks and hematoma blocks for post operative pain relief for femoral shaft fractures in a pediatric population.
Children with femur fractures can have severe pain after elastic nail fixation. The current national standard for post operative pain control would be intravenous narcotics. In addition to the use of intravenous narcotics, there are two alternative methods used during the surgery in order to potentially decrease the pain post-operatively. These methods are hematoma block or a femoral nerve block. Both are proven safe and effective in children, however little research has been done to look at the effectiveness of these various methods compared to one another.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCA only | No Intervention | this group will only get a pain control anesthesia pump to use for post-operative pain | |
| PCA and femoral nerve block | Experimental | this group will be receiving a femoral nerve block during surgery and have a PCA post-operatively |
|
| PCA + hematoma block | Experimental | patient will receive hematoma block during surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marcaine | Drug | 0.75 cc/kg of 1/4% Marcaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Pain Scores | We will be looking at post-operative pain scores to see if those in the intervention group have lower pains scores. Wong Baker FACES pain scale:The faces correspond to numeric values from 0-5. This scale can be documented with the numeric value. The pain scale goes from 0-5 with 0 being no pain and 5 being the worst pain. 0: No Hurt
| with in the first 24 hours |
| Post-operative Narcotic Use | We will be looking at the amount of narcotics used after surgery to see if there is a reduction in narcotic use | within first 24 horus |
| Measure | Description | Time Frame |
|---|---|---|
| Femur Fracture Healing | we will following patients to look at fracture healing post-operatively | first year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J. Eric Gordon, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Louis Childrens Hospital | St Louis | Missouri | 63110 | United States | ||
| Washington University |
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| ID | Title | Description |
|---|---|---|
| FG000 | PCA Only | this group will only get a pain control anesthesia pump to use for post-operative pain |
| FG001 | PCA and Femoral Nerve Block | this group will be receiving a femoral nerve block during surgery and have a PCA post-operatively Marcaine: 0.75 cc/kg of 1/4% Marcaine |
| FG002 | PCA + Hematoma Block | patient will receive hematoma block during surgery Marcaine: 0.75 cc/kg of 1/4% Marcaine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PCA Only | this group will only get a pain control anesthesia pump to use for post-operative pain |
| BG001 | PCA and Femoral Nerve Block | this group will be receiving a femoral nerve block during surgery and have a PCA post-operatively Marcaine: 0.75 cc/kg of 1/4% Marcaine |
| 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 | Post-operative Pain Scores | We will be looking at post-operative pain scores to see if those in the intervention group have lower pains scores. Wong Baker FACES pain scale:The faces correspond to numeric values from 0-5. This scale can be documented with the numeric value. The pain scale goes from 0-5 with 0 being no pain and 5 being the worst pain. 0: No Hurt
| Posted | Mean | Full Range | units on a scale | with in the first 24 hours |
|
1 year
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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 | PCA Only | this group will only get a pain control anesthesia pump to use for post-operative pain |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lauren Westlund | Washington University School of Medicine | 314-454-5345 | davislauren@wustl.edu |
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| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| St Louis |
| Missouri |
| 63110 |
| United States |
| BG002 | PCA + Hematoma Block | patient will receive hematoma block during surgery Marcaine: 0.75 cc/kg of 1/4% Marcaine |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | PCA + Hematoma Block | patient will receive hematoma block during surgery Marcaine: 0.75 cc/kg of 1/4% Marcaine |
|
|
| Primary | Post-operative Narcotic Use | We will be looking at the amount of narcotics used after surgery to see if there is a reduction in narcotic use | Posted | Number | mg | within first 24 horus |
|
|
|
| Secondary | Femur Fracture Healing | we will following patients to look at fracture healing post-operatively | Posted | Number | weeks | first year |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | PCA and Femoral Nerve Block | this group will be receiving a femoral nerve block during surgery and have a PCA post-operatively Marcaine: 0.75 cc/kg of 1/4% Marcaine | 0 | 1 | 0 | 1 | 0 | 1 |
| EG002 | PCA + Hematoma Block | patient will receive hematoma block during surgery Marcaine: 0.75 cc/kg of 1/4% Marcaine | 0 | 1 | 0 | 1 | 0 | 1 |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |