Femoral Fractures, Pain, Postoperative
Conditions
Keywords
Femoral Fractures, Pediatrics, Pain, Postoperative
Brief summary
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.
Detailed description
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.
Interventions
DRUGMarcaine
0.75 cc/kg of 1/4% Marcaine
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* A child with a femoral shaft fracture requiring surgical treatment and the placement of intramedullary nails * Weight of 30-100 Kg * Child must be older than 6 years old
Exclusion criteria
* Any child that had an open fracture * A child that has a pain abnormality * Any child with an allergy to local anesthetic * Any child with a neurological injury * Any child with the inability to report pain * Any child that is unable to use a PCA post-operatively
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pain Scores | with in the first 24 hours | 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 1. Hurts a little bit 2. Hurts a little more 3. Hurts even more 4. Hurts a whole lot 5. Hurts worst |
| Post-operative Narcotic Use | within first 24 horus | We will be looking at the amount of narcotics used after surgery to see if there is a reduction in narcotic use |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Femur Fracture Healing | first year | we will following patients to look at fracture healing post-operatively |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PCA Only this group will only get a pain control anesthesia pump to use for post-operative pain | 0 |
| 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 | 1 |
| PCA + Hematoma Block patient will receive hematoma block during surgery
Marcaine: 0.75 cc/kg of 1/4% Marcaine | 1 |
| Total | 2 |
Baseline characteristics
| Characteristic | PCA + Hematoma Block | PCA and Femoral Nerve Block | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 8 years | 13 years | 10.5 years |
| Region of Enrollment United States | 1 participants | 1 participants | 2 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 0 / 0 | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 0 | 0 / 1 | 0 / 1 |
Outcome results
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
Time frame: within first 24 horus
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PCA and Femoral Nerve Block | Post-operative Narcotic Use | 14.4 mg |
| PCA + Hematoma Block | Post-operative Narcotic Use | 3.2 mg |
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 1. Hurts a little bit 2. Hurts a little more 3. Hurts even more 4. Hurts a whole lot 5. Hurts worst
Time frame: with in the first 24 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PCA and Femoral Nerve Block | Post-operative Pain Scores | 1.1 units on a scale |
| PCA + Hematoma Block | Post-operative Pain Scores | .11 units on a scale |
Secondary
Femur Fracture Healing
we will following patients to look at fracture healing post-operatively
Time frame: first year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PCA and Femoral Nerve Block | Femur Fracture Healing | 24 weeks |
| PCA + Hematoma Block | Femur Fracture Healing | 10 weeks |