Trial Outcomes & Findings for Surgical Treatment of Hip Fractures Under Peripheral Regional Anesthesia (NCT NCT04005404)
NCT ID: NCT04005404
Last Updated: 2021-02-18
Results Overview
number of participants with need for supplemental analgesic medication (sufentanil)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
during surgery
Results posted on
2021-02-18
Participant Flow
Participant milestones
| Measure |
Intertrochanteric Femoral Fractures
Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%
|
Neck Femur Fractures
Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%
|
Subtrochanteric Femoral Fractures
Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%
|
|---|---|---|---|
|
Overall Study
STARTED
|
43
|
34
|
3
|
|
Overall Study
COMPLETED
|
42
|
33
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Surgical Treatment of Hip Fractures Under Peripheral Regional Anesthesia
Baseline characteristics by cohort
| Measure |
Intertrochanteric Femoral Fractures
n=42 Participants
Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%
|
Neck Femur Fractures
n=33 Participants
Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%
|
Subtrochanteric Femoral Fractures
n=3 Participants
Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
87 years
n=5 Participants
|
84 years
n=7 Participants
|
79 years
n=5 Participants
|
85 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
42 participants
n=5 Participants
|
33 participants
n=7 Participants
|
3 participants
n=5 Participants
|
78 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: during surgerynumber of participants with need for supplemental analgesic medication (sufentanil)
Outcome measures
| Measure |
Intertrochanteric Femoral Fractures
n=42 Participants
Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%
|
Neck Femur Fractures
n=33 Participants
Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%
|
Subtrochanteric Femoral Fractures
n=3 Participants
Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%
|
|---|---|---|---|
|
Success Rate (Supplemental Medication)
|
22 Participants
|
20 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: during surgerynumber of participants with need for conversion to general anesthesia
Outcome measures
| Measure |
Intertrochanteric Femoral Fractures
n=42 Participants
Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%
|
Neck Femur Fractures
n=33 Participants
Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%
|
Subtrochanteric Femoral Fractures
n=3 Participants
Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%
|
|---|---|---|---|
|
Success Rate (Conversion to General Anesthesia)
|
1 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: during surgerynumber of participants with need for application of ephedrine and/or norepinephrine
Outcome measures
| Measure |
Intertrochanteric Femoral Fractures
n=42 Participants
Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%
|
Neck Femur Fractures
n=33 Participants
Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%
|
Subtrochanteric Femoral Fractures
n=3 Participants
Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%
|
|---|---|---|---|
|
Circulation Stability
|
15 Participants
|
15 Participants
|
2 Participants
|
Adverse Events
Intertrochanteric Femoral Fractures
Serious events: 21 serious events
Other events: 0 other events
Deaths: 6 deaths
Neck Femur Fractures
Serious events: 16 serious events
Other events: 0 other events
Deaths: 3 deaths
Subtrochanteric Femoral Fractures
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intertrochanteric Femoral Fractures
n=42 participants at risk
Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%
|
Neck Femur Fractures
n=33 participants at risk
Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%
|
Subtrochanteric Femoral Fractures
n=3 participants at risk
Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%
Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%
|
|---|---|---|---|
|
Nervous system disorders
epidural anesthesia
|
0.00%
0/42 • 30 days after surgery
|
3.0%
1/33 • Number of events 1 • 30 days after surgery
|
0.00%
0/3 • 30 days after surgery
|
|
Nervous system disorders
delirium
|
11.9%
5/42 • Number of events 5 • 30 days after surgery
|
9.1%
3/33 • Number of events 3 • 30 days after surgery
|
0.00%
0/3 • 30 days after surgery
|
|
Renal and urinary disorders
kidney injury
|
4.8%
2/42 • Number of events 2 • 30 days after surgery
|
9.1%
3/33 • Number of events 3 • 30 days after surgery
|
0.00%
0/3 • 30 days after surgery
|
|
Cardiac disorders
ventricular tachycardia
|
2.4%
1/42 • Number of events 1 • 30 days after surgery
|
0.00%
0/33 • 30 days after surgery
|
0.00%
0/3 • 30 days after surgery
|
|
Cardiac disorders
heart failure
|
4.8%
2/42 • Number of events 2 • 30 days after surgery
|
9.1%
3/33 • Number of events 3 • 30 days after surgery
|
0.00%
0/3 • 30 days after surgery
|
|
Cardiac disorders
myocardial infarction
|
4.8%
2/42 • Number of events 2 • 30 days after surgery
|
3.0%
1/33 • Number of events 1 • 30 days after surgery
|
0.00%
0/3 • 30 days after surgery
|
|
Renal and urinary disorders
urinary tract infection
|
9.5%
4/42 • Number of events 4 • 30 days after surgery
|
6.1%
2/33 • Number of events 2 • 30 days after surgery
|
0.00%
0/3 • 30 days after surgery
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
7.1%
3/42 • Number of events 3 • 30 days after surgery
|
6.1%
2/33 • Number of events 2 • 30 days after surgery
|
0.00%
0/3 • 30 days after surgery
|
|
Surgical and medical procedures
hematoma
|
4.8%
2/42 • Number of events 2 • 30 days after surgery
|
0.00%
0/33 • 30 days after surgery
|
0.00%
0/3 • 30 days after surgery
|
|
Surgical and medical procedures
wound infection
|
0.00%
0/42 • 30 days after surgery
|
3.0%
1/33 • Number of events 1 • 30 days after surgery
|
0.00%
0/3 • 30 days after surgery
|
Other adverse events
Adverse event data not reported
Additional Information
Director Prof. Dr. Petra Thürmann
Helios Center for Research and Innovation
Phone: 0049 (0)202 896-1851
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place