Traumatic Femur Fracture
Conditions
Brief summary
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.
Interventions
DRUGRopivicaine
DRUGEpinephrine
Sponsors
Nationwide Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) physical status I or II * Weight greater than or equal to 10kg * Presenting for repair of traumatic femur fracture
Exclusion criteria
* ASA physical status \> II * Co-morbid diseases (cardiac, pulmonary, neurological disease) * Patients having concomitant procedures * Abnormal neurovascular examination in the injured leg * Presence of vascular compromise in the affected lower extremity * Mechanism of sustained injury via crush injury * Use of therapeutic dose anticoagulants or presence of a bleeding disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-anesthesia Care Unit (PACU) Pain Scores | 30 mins after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative End-tidal Isoflurane % | 1 1/2 hr. | Median end-tidal isoflurane concentration per participant during the average 1 1/2 hr. surgery. |
| Time to First Opioid Dose | From PACU discharge until first opioid dose on the ward, assessed up to 24 hours | Median time between PACU discharge and first opioid dose on the ward. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| Standard Anesthetic Management | 7 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 2 |
Baseline characteristics
| Characteristic | Femoral Nerve Block | Standard Anesthetic Management | Total |
|---|---|---|---|
| Age, Continuous | 8.1 years STANDARD_DEVIATION 3.5 | 7.7 years STANDARD_DEVIATION 3.4 | 8 years STANDARD_DEVIATION 3 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 7 |
| serious Total, serious adverse events | 0 / 10 | 0 / 7 |
Outcome results
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.
Time frame: 30 mins after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Femoral Nerve Block | Post-anesthesia Care Unit (PACU) Pain Scores | 0 pain score |
| Standard Anesthetic Management | Post-anesthesia Care Unit (PACU) Pain Scores | 3 pain score |
Secondary
Intraoperative End-tidal Isoflurane %
Median end-tidal isoflurane concentration per participant during the average 1 1/2 hr. surgery.
Time frame: 1 1/2 hr.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Femoral Nerve Block | Intraoperative End-tidal Isoflurane % | 1.1 percentage of isoflurane |
| Standard Anesthetic Management | Intraoperative End-tidal Isoflurane % | 1.5 percentage of isoflurane |
Secondary
Time to First Opioid Dose
Median time between PACU discharge and first opioid dose on the ward.
Time frame: From PACU discharge until first opioid dose on the ward, assessed up to 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Femoral Nerve Block | Time to First Opioid Dose | 3.3 hours |
| Standard Anesthetic Management | Time to First Opioid Dose | 3.8 hours |