Surgical Treatment of Hip Fractures Under Peripheral Regional Anesthesia

Study Overview
=================
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.

Official Title
-----------------
Surgical Treatment of Proximal Femoral Fractures Under Peripheral Regional Anesthesia. A Prospective Pilot Study

Conditions
-----------------
Hip Fractures

Intervention / Treatment
-----------------
* Drug: Ropivacaine (sciatic nerve block)
* Drug: Ropivacaine (lumbar plexus block L2-L4)
* Drug: Ropivacaine (lumbar plexus block Th12-L1)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Differentiated analysis for the subgroups subtrochanteric femoral fractures, intertrochanteric femoral fractures and neck femur fractures
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intertrochanteric femoral fractures<br>geriatric patients with intertrochanteric femoral fracture who have consented to the study intervention | Drug: Ropivacaine (sciatic nerve block)<br>* injection of 20 ml ropivacaine 0.375%<br>* Other names: parasacral sciatic nerve block (sacral plexus);Drug: Ropivacaine (lumbar plexus block L2-L4)<br>* injection of 20 ml ropivacaine 0.375%<br>* Other names: posts compartment block (lumbar plexus L2-L4);Drug: Ropivacaine (lumbar plexus block Th12-L1)<br>* injection of 20 ml ropivacaine 0.375%<br>* Other names: transmuscular quadratus lumborum block (lumbar plexus Th12-L1);|
| Experimental: neck femur fractures<br>geriatric patients with neck of femur fracture who have consented to the study intervention | Drug: Ropivacaine (sciatic nerve block)<br>* injection of 20 ml ropivacaine 0.375%<br>* Other names: parasacral sciatic nerve block (sacral plexus);Drug: Ropivacaine (lumbar plexus block L2-L4)<br>* injection of 20 ml ropivacaine 0.375%<br>* Other names: posts compartment block (lumbar plexus L2-L4);Drug: Ropivacaine (lumbar plexus block Th12-L1)<br>* injection of 20 ml ropivacaine 0.375%<br>* Other names: transmuscular quadratus lumborum block (lumbar plexus Th12-L1);|
| Experimental: subtrochanteric femoral fractures<br>geriatric patients with subtrochanteric femoral fracture who have consented to the study intervention | Drug: Ropivacaine (sciatic nerve block)<br>* injection of 20 ml ropivacaine 0.375%<br>* Other names: parasacral sciatic nerve block (sacral plexus);Drug: Ropivacaine (lumbar plexus block L2-L4)<br>* injection of 20 ml ropivacaine 0.375%<br>* Other names: posts compartment block (lumbar plexus L2-L4);Drug: Ropivacaine (lumbar plexus block Th12-L1)<br>* injection of 20 ml ropivacaine 0.375%<br>* Other names: transmuscular quadratus lumborum block (lumbar plexus Th12-L1);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success Rate (Supplemental Medication) | number of participants with need for supplemental analgesic medication (sufentanil) | during surgery | 
| Success Rate (Conversion to General Anesthesia) | number of participants with need for conversion to general anesthesia | during surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulation Stability | number of participants with need for application of ephedrine and/or norepinephrine | during surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Regional Anesthesia, Ultrasonography, Hip Fractures, Lumbosacral Plexus