Hip Fractures
Conditions
Keywords
Regional Anesthesia, Ultrasonography, Hip Fractures, Lumbosacral Plexus
Brief summary
The study investigates whether treatment of proximal femoral fractures is possible using a peripheral regional anesthesia technique.
Detailed description
The study investigates whether treatment of proximal femoral fractures is possible using a peripheral regional anesthesia technique. After positioning on the non-fractured side, a double injection technique is used (dual guidance concept: nerve stimulation and sonography). The injections are performed parasacrally (blockade of the sacral plexus under the piriformis muscle) and lumbar paravertebrally (psoas compartment block and transmuscular quadratus lumborum block). Per block 20 ml ropivacaine 0.375% is administered (total dose: 225mg ropivacaine). The study examines the success rate (rate of successfully performed nerve blockade; need for supplemental medication: sufentanil and/or propofol; conversion rate to general anesthesia), circulatory stability (need for application of ephedrine or norepinephrine) and side effects.
Interventions
DRUGRopivacaine (sciatic nerve block)
injection of 20 ml ropivacaine 0.375%
DRUGRopivacaine (lumbar plexus block L2-L4)
injection of 20 ml ropivacaine 0.375%
DRUGRopivacaine (lumbar plexus block Th12-L1)
injection of 20 ml ropivacaine 0.375%
Sponsors
Helios Research Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Differentiated analysis for the subgroups subtrochanteric femoral fractures, intertrochanteric femoral fractures and neck femur fractures
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* proximal femoral fracture * older then 18 years * written informed consent
Exclusion criteria
* local or systematic inflammation * allergy to ropivacaine * participate in other studies * body mass index over 35 * periprosthetic fractures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate (Supplemental Medication) | during surgery | number of participants with need for supplemental analgesic medication (sufentanil) |
| Success Rate (Conversion to General Anesthesia) | during surgery | number of participants with need for conversion to general anesthesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Circulation Stability | during surgery | number of participants with need for application of ephedrine and/or norepinephrine |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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% | 42 |
| 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% | 33 |
| 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% | 3 |
| Total | 78 |
Baseline characteristics
| Characteristic | Intertrochanteric Femoral Fractures | Total | Subtrochanteric Femoral Fractures | Neck Femur Fractures |
|---|---|---|---|---|
| Age, Continuous | 87 years | 85 years | 79 years | 84 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 42 Participants | 78 Participants | 3 Participants | 33 Participants |
| Region of Enrollment Germany | 42 participants | 78 participants | 3 participants | 33 participants |
| Sex: Female, Male Female | 31 Participants | 53 Participants | 3 Participants | 19 Participants |
| Sex: Female, Male Male | 11 Participants | 25 Participants | 0 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 6 / 42 | 3 / 33 | 0 / 3 |
| other Total, other adverse events | 0 / 42 | 0 / 33 | 0 / 3 |
| serious Total, serious adverse events | 21 / 42 | 16 / 33 | 0 / 3 |
Outcome results
Primary
Success Rate (Conversion to General Anesthesia)
number of participants with need for conversion to general anesthesia
Time frame: during surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intertrochanteric Femoral Fractures | Success Rate (Conversion to General Anesthesia) | 1 Participants |
| Neck Femur Fractures | Success Rate (Conversion to General Anesthesia) | 3 Participants |
| Subtrochanteric Femoral Fractures | Success Rate (Conversion to General Anesthesia) | 1 Participants |
Primary
Success Rate (Supplemental Medication)
number of participants with need for supplemental analgesic medication (sufentanil)
Time frame: during surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intertrochanteric Femoral Fractures | Success Rate (Supplemental Medication) | 22 Participants |
| Neck Femur Fractures | Success Rate (Supplemental Medication) | 20 Participants |
| Subtrochanteric Femoral Fractures | Success Rate (Supplemental Medication) | 3 Participants |
Secondary
Circulation Stability
number of participants with need for application of ephedrine and/or norepinephrine
Time frame: during surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intertrochanteric Femoral Fractures | Circulation Stability | 15 Participants |
| Neck Femur Fractures | Circulation Stability | 15 Participants |
| Subtrochanteric Femoral Fractures | Circulation Stability | 2 Participants |