Trial Outcomes & Findings for A Retrospective Investigation of Local Anesthetic Concentrations in Femoral Nerve Block (NCT NCT02501135)
NCT ID: NCT02501135
Last Updated: 2019-03-06
Results Overview
Recruitment status
COMPLETED
Target enrollment
281 participants
Primary outcome timeframe
length of surgery
Results posted on
2019-03-06
Participant Flow
Participant milestones
| Measure |
Femoral Nerve Blocks
Patients who receive ropivacaine or bupivacaine during femoral nerve block.
Femoral nerve block with ropivacaine or bupivacaine
|
|---|---|
|
Overall Study
STARTED
|
281
|
|
Overall Study
COMPLETED
|
281
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Retrospective Investigation of Local Anesthetic Concentrations in Femoral Nerve Block
Baseline characteristics by cohort
| Measure |
Femoral Nerve Blocks
n=281 Participants
Patients who receive ropivacaine or bupivacaine during femoral nerve block.
Femoral nerve block with ropivacaine or bupivacaine
|
|---|---|
|
Age, Categorical
<=18 years
|
281 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
14.5 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
172 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
281 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: length of surgeryOutcome measures
| Measure |
Femoral Nerve Blocks
n=281 Participants
Patients who receive ropivacaine or bupivacaine during femoral nerve block.
Femoral nerve block with ropivacaine or bupivacaine
|
|---|---|
|
Concentration of Local Anesthetic Injected for Femoral Nerve Block
Patients who received ropivacaine 0.2%
|
117 Participants
|
|
Concentration of Local Anesthetic Injected for Femoral Nerve Block
Patients who received ropivacaine 0.5%
|
81 Participants
|
|
Concentration of Local Anesthetic Injected for Femoral Nerve Block
Patients who received bupivacaine 0.25%
|
83 Participants
|
PRIMARY outcome
Timeframe: length of surgeryOutcome measures
| Measure |
Femoral Nerve Blocks
n=281 Participants
Patients who receive ropivacaine or bupivacaine during femoral nerve block.
Femoral nerve block with ropivacaine or bupivacaine
|
|---|---|
|
Total mg of Local Anesthetic Injected for Femoral Nerve Block
Amount of ropivacaine 0.2%
|
0.27 ml/kg
Interval 0.22 to 0.35
|
|
Total mg of Local Anesthetic Injected for Femoral Nerve Block
Amount of ropivacaine 0.5%
|
0.29 ml/kg
Interval 0.22 to 0.35
|
|
Total mg of Local Anesthetic Injected for Femoral Nerve Block
Amount of bupivacaine 0.25%
|
0.25 ml/kg
Interval 0.19 to 0.32
|
PRIMARY outcome
Timeframe: length of surgeryAmount of Tylenol administered based on if got ropivacaine or bupivacaine femeral nerve block.
Outcome measures
| Measure |
Femoral Nerve Blocks
n=281 Participants
Patients who receive ropivacaine or bupivacaine during femoral nerve block.
Femoral nerve block with ropivacaine or bupivacaine
|
|---|---|
|
Intraoperative Tylenol Administered
Increased Tylenol use in ropivacaine 0.5% NB
|
16 percentage of participants
|
|
Intraoperative Tylenol Administered
Increased Tylenol use in ropivacaine 0.2% NB
|
4 percentage of participants
|
|
Intraoperative Tylenol Administered
Increased Tylenol use in bupivacaine 0.25% NB
|
1 percentage of participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Femoral Nerve Blocks
n=281 Participants
Patients who receive ropivacaine or bupivacaine during femoral nerve block.
Femoral nerve block with ropivacaine or bupivacaine
|
|---|---|
|
Post-operative Opioids Administered
IV Morphine who got ropivacaine 0.5% nerve block
|
0 mg/kg
Interval 0.0 to 0.04
|
|
Post-operative Opioids Administered
IV Morphine who got ropivacaine 0.2% nerve block
|
0.02 mg/kg
Interval 0.0 to 0.07
|
|
Post-operative Opioids Administered
IV Morphine who got bupivacaine 0.25% nerve block
|
0.02 mg/kg
Interval 0.0 to 0.08
|
SECONDARY outcome
Timeframe: Conclusion of surgery until admission to assigned unit or to phase, an expected average of 1 hourPopulation: One patient was excluded from analysis of time to PACU discharge due to a missing PACU arrival time.
Outcome measures
| Measure |
Femoral Nerve Blocks
n=280 Participants
Patients who receive ropivacaine or bupivacaine during femoral nerve block.
Femoral nerve block with ropivacaine or bupivacaine
|
|---|---|
|
Time to Discharge From PACU
PACU time in pt who got ropivacaine 0.2%
|
57 minutes
Interval 41.0 to 76.0
|
|
Time to Discharge From PACU
PACU time in pt who got ropivacaine 0.5%
|
47 minutes
Interval 36.0 to 68.0
|
|
Time to Discharge From PACU
PACU time in pt who got bupivacaine 0.25%
|
55 minutes
Interval 35.0 to 80.0
|
SECONDARY outcome
Timeframe: 1 hour post-opPopulation: 63 of the 281 total subjects had their pain assessed using the FLACC pain scale.
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.
Outcome measures
| Measure |
Femoral Nerve Blocks
n=63 Participants
Patients who receive ropivacaine or bupivacaine during femoral nerve block.
Femoral nerve block with ropivacaine or bupivacaine
|
|---|---|
|
Post-operative Pain Scale Using FLACC
FLACC in patient who had bupivacaine 0.25%
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Post-operative Pain Scale Using FLACC
FLACC in patient who had ropivacaine 0.2%
|
0 units on a scale
Interval 0.0 to 2.0
|
|
Post-operative Pain Scale Using FLACC
FLACC in patient who had ropivacaine 0.5%
|
0 units on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 1 hour post-opPopulation: 197 out of the total 281 subjects had their pain assessed 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."
Outcome measures
| Measure |
Femoral Nerve Blocks
n=197 Participants
Patients who receive ropivacaine or bupivacaine during femoral nerve block.
Femoral nerve block with ropivacaine or bupivacaine
|
|---|---|
|
Post-operative Pain Scale Using VAS
Ropivacaine 0.2%
|
0 units on a scale
Interval 0.0 to 5.0
|
|
Post-operative Pain Scale Using VAS
Ropivacaine 0.5%
|
0 units on a scale
Interval 0.0 to 4.0
|
|
Post-operative Pain Scale Using VAS
Bupivacaine 0.25%
|
0 units on a scale
Interval 0.0 to 6.0
|
Adverse Events
Femoral Nerve Blocks
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Clinical Research Coordinator
Nationwide Children's Hospital
Phone: 6147222997
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place