Clinical trial NCT04005404: Surgical Treatment of Hip Fractures Under Peripheral Regional Anesthesia
Official title: Surgical Treatment of Proximal Femoral Fractures Under Peripheral Regional Anesthesia. A Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Keywords: Regional Anesthesia
Ultrasonography
Hip Fractures
Lumbosacral Plexus
Lead sponsor: Helios Research Center
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Differentiated analysis for the subgroups "subtrochanteric femoral fractures", "intertrochanteric femoral fractures" and "neck femur fractures"
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Success Rate (Supplemental Medication)
timeFrame: during surgery
measure: Success Rate (Conversion to General Anesthesia)
timeFrame: during surgery
Secondary outcomes:
measure: Circulation Stability
timeFrame: during surgery
Other outcomes:
Locations:
city: Schwerin
country: Germany
facility: Helios Medical Center Schwerin, Department of Anesthesiology
state: Mecklenburg-Vorpommern
Study officials:
References:
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