Postoperative Pain
Conditions
Keywords
Femoral nerve blocks, children, knee and thigh surgery
Brief summary
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.
Interventions
PROCEDUREFemoral nerve block with ropivacaine or bupivacaine
Sponsors
Giorgio Veneziano
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* ASA physical status I or II * Age \< or equal to 18 years of age at time of femoral nerve block * Femoral nerve block performed from 2010-2015
Exclusion criteria
* ASA physical status \> II * Co-morbid diseases (cardiac, pulmonary, neurological disease) * Use of adjunctive medications in femoral nerve block (except for epinephrine), such as dexamethasone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | length of surgery | Amount of Tylenol administered based on if got ropivacaine or bupivacaine femeral nerve block. |
| Post-operative Opioids Administered | in PACU (1 hr post-op) | Amount of opioid consumption in the post operative anesthesia care unit depending on if the patient received femoral nerve block with ropivacaine or bupivacaine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pain Scale Using FLACC | 1 hour post-op | 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. |
| Post-operative Pain Scale Using VAS | 1 hour post-op | 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. |
| Time to Discharge From PACU | Conclusion of surgery until admission to assigned unit or to phase, an expected average of 1 hour | — |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Femoral Nerve Blocks Patients who receive ropivacaine or bupivacaine during femoral nerve block.
Femoral nerve block with ropivacaine or bupivacaine | 281 |
| Total | 281 |
Baseline characteristics
| Characteristic | Femoral Nerve Blocks |
|---|---|
| Age, Categorical <=18 years | 281 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 14.5 years |
| Region of Enrollment United States | 281 participants |
| Sex: Female, Male Female | 109 Participants |
| Sex: Female, Male Male | 172 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 281 |
| other Total, other adverse events | 0 / 281 |
| serious Total, serious adverse events | 0 / 281 |
Outcome results
Primary
Concentration of Local Anesthetic Injected for Femoral Nerve Block
Time frame: length of surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Femoral Nerve Blocks | Concentration of Local Anesthetic Injected for Femoral Nerve Block | Patients who received ropivacaine 0.2% | 117 Participants |
| Femoral Nerve Blocks | Concentration of Local Anesthetic Injected for Femoral Nerve Block | Patients who received ropivacaine 0.5% | 81 Participants |
| Femoral Nerve Blocks | Concentration of Local Anesthetic Injected for Femoral Nerve Block | Patients who received bupivacaine 0.25% | 83 Participants |
Primary
Intraoperative Tylenol Administered
Amount of Tylenol administered based on if got ropivacaine or bupivacaine femeral nerve block.
Time frame: length of surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Femoral Nerve Blocks | Intraoperative Tylenol Administered | Increased Tylenol use in ropivacaine 0.5% NB | 16 percentage of participants |
| Femoral Nerve Blocks | Intraoperative Tylenol Administered | Increased Tylenol use in ropivacaine 0.2% NB | 4 percentage of participants |
| Femoral Nerve Blocks | Intraoperative Tylenol Administered | Increased Tylenol use in bupivacaine 0.25% NB | 1 percentage of participants |
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
Time frame: in PACU (1 hr post-op)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Femoral Nerve Blocks | Post-operative Opioids Administered | IV Morphine who got ropivacaine 0.5% nerve block | 0 mg/kg |
| Femoral Nerve Blocks | Post-operative Opioids Administered | IV Morphine who got ropivacaine 0.2% nerve block | 0.02 mg/kg |
| Femoral Nerve Blocks | Post-operative Opioids Administered | IV Morphine who got bupivacaine 0.25% nerve block | 0.02 mg/kg |
Primary
Total mg of Local Anesthetic Injected for Femoral Nerve Block
Time frame: length of surgery
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Femoral Nerve Blocks | Total mg of Local Anesthetic Injected for Femoral Nerve Block | Amount of ropivacaine 0.2% | 0.27 ml/kg |
| Femoral Nerve Blocks | Total mg of Local Anesthetic Injected for Femoral Nerve Block | Amount of ropivacaine 0.5% | 0.29 ml/kg |
| Femoral Nerve Blocks | Total mg of Local Anesthetic Injected for Femoral Nerve Block | Amount of bupivacaine 0.25% | 0.25 ml/kg |
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.
Time frame: 1 hour post-op
Population: 63 of the 281 total subjects had their pain assessed using the FLACC pain scale.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Femoral Nerve Blocks | Post-operative Pain Scale Using FLACC | FLACC in patient who had ropivacaine 0.2% | 0 units on a scale |
| Femoral Nerve Blocks | Post-operative Pain Scale Using FLACC | FLACC in patient who had bupivacaine 0.25% | 0 units on a scale |
| Femoral Nerve Blocks | Post-operative Pain Scale Using FLACC | FLACC in patient who had ropivacaine 0.5% | 0 units on a scale |
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.
Time frame: 1 hour post-op
Population: 197 out of the total 281 subjects had their pain assessed using VAS.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Femoral Nerve Blocks | Post-operative Pain Scale Using VAS | Ropivacaine 0.2% | 0 units on a scale |
| Femoral Nerve Blocks | Post-operative Pain Scale Using VAS | Ropivacaine 0.5% | 0 units on a scale |
| Femoral Nerve Blocks | Post-operative Pain Scale Using VAS | Bupivacaine 0.25% | 0 units on a scale |
Secondary
Time to Discharge From PACU
Time frame: Conclusion of surgery until admission to assigned unit or to phase, an expected average of 1 hour
Population: One patient was excluded from analysis of time to PACU discharge due to a missing PACU arrival time.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Femoral Nerve Blocks | Time to Discharge From PACU | PACU time in pt who got ropivacaine 0.5% | 47 minutes |
| Femoral Nerve Blocks | Time to Discharge From PACU | PACU time in pt who got bupivacaine 0.25% | 55 minutes |
| Femoral Nerve Blocks | Time to Discharge From PACU | PACU time in pt who got ropivacaine 0.2% | 57 minutes |