Trial Outcomes & Findings for Ultrasound-guided Fascia Iliaca Compartment Block Versus Periarticular Infiltration (NCT NCT02658240)
NCT ID: NCT02658240
Last Updated: 2018-11-29
Results Overview
The Visual Analog Pain Score (VAS) at resting on the scale of 10 (0= No pain, 10= Worst pain) at 48 hours postoperatively
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Postoperative 48 hours
Results posted on
2018-11-29
Participant Flow
Participant milestones
| Measure |
Compartment Block
Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery
Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL
Epinephrine: 0.5 mg epinephrine
|
Infiltration
Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision
Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL
Epinephrine: 0.5 mg epinephrine
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ultrasound-guided Fascia Iliaca Compartment Block Versus Periarticular Infiltration
Baseline characteristics by cohort
| Measure |
Compartment Block
n=30 Participants
Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery
Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL
Epinephrine: 0.5 mg epinephrine
|
Infiltration
n=30 Participants
Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision
Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL
Epinephrine: 0.5 mg epinephrine
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.2 years
STANDARD_DEVIATION 13.6 • n=99 Participants
|
59.0 years
STANDARD_DEVIATION 11.2 • n=107 Participants
|
57.6 years
STANDARD_DEVIATION 12.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Preoperative Pain Score at Rest
|
3 units on a scale
n=99 Participants
|
4 units on a scale
n=107 Participants
|
4 units on a scale
n=206 Participants
|
|
Preoperative Pain Score with Cough
|
4 units on a scale
n=99 Participants
|
8 units on a scale
n=107 Participants
|
8 units on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: Postoperative 48 hoursThe Visual Analog Pain Score (VAS) at resting on the scale of 10 (0= No pain, 10= Worst pain) at 48 hours postoperatively
Outcome measures
| Measure |
Compartment Block
n=30 Participants
Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery
Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL
Epinephrine: 0.5 mg epinephrine
|
Infiltration
n=30 Participants
Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision
Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL
Epinephrine: 0.5 mg epinephrine
|
|---|---|---|
|
Postoperative Pain Score at Resting
|
1 units on a scale
Interval 0.0 to 2.0
|
2 units on a scale
Interval 1.0 to 2.0
|
PRIMARY outcome
Timeframe: Postoperative 48 hoursThe Visual Analog Pain Score (VAS) with movement on the scale of 10 (0= No pain, 10= Worst pain) at 48 hours postoperatively
Outcome measures
| Measure |
Compartment Block
n=30 Participants
Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery
Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL
Epinephrine: 0.5 mg epinephrine
|
Infiltration
n=30 Participants
Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision
Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL
Epinephrine: 0.5 mg epinephrine
|
|---|---|---|
|
Postoperative Pain Score With Movement
|
3 units on a scale
Interval 2.0 to 4.0
|
4 units on a scale
Interval 3.0 to 5.0
|
SECONDARY outcome
Timeframe: Postoperative 48 hoursTotal amounts of postoperative opioid requirements for 48 hours postoperatively
Outcome measures
| Measure |
Compartment Block
n=30 Participants
Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery
Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL
Epinephrine: 0.5 mg epinephrine
|
Infiltration
n=30 Participants
Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision
Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL
Epinephrine: 0.5 mg epinephrine
|
|---|---|---|
|
Oral Morphine Equivalents of Postoperative Opioid Requirements for 48 Hours
|
101.0 Oral Morphine Equivalent (mg)
Standard Deviation 29.5
|
115.6 Oral Morphine Equivalent (mg)
Standard Deviation 46
|
SECONDARY outcome
Timeframe: Postoperative 48 hoursThe time to ambulation during 48 hours postoperative period
Outcome measures
| Measure |
Compartment Block
n=30 Participants
Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery
Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL
Epinephrine: 0.5 mg epinephrine
|
Infiltration
n=30 Participants
Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision
Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL
Epinephrine: 0.5 mg epinephrine
|
|---|---|---|
|
The Time to Ambulation
|
21.3 Hours
Interval 19.0 to 23.5
|
22 Hours
Interval 19.5 to 24.0
|
Adverse Events
Compartment Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Infiltration
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place