Ultrasound-assisted Shamrock Method for Lumbar Plexus Nerve Block in Elderly Trauma Patients, Revisited.

Study Overview
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Brief Summary
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A revised ultrasound-guided approach to the lumbar plexus is investigated as for efficacy and safety in elderly trauma patients undergoing operations of the lower extremeties.

Detailed Description
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A modified ultrasound-guided Shamrock approach combined to nerve stimulation of the lumbar plexus is going to be investigated, in elderly trauma patients undergoing procedures of the lower extremities. The technique is going to be assessed as for its safety and its accuracy in localization of the plexus, by multiple measurements of the imaging time and needling time, In addition, efficacy and complications will be recorded and assessed during the immediate postoperative period.

Official Title
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Ultrasound-assisted Shamrock Method for Lumbar Plexus Nerve Block in Elderly Trauma Patients, Revisited.

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: lumbar plexus block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing orthopedic trauma operations of the lower extremeties Age >70 years old Exclusion Criteria: Preexisting neuropathy of Lumbar plexus Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50) Allergy to local anaesthetics Prior surgery at the lumbar region

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Modified Shamrock approach<br>Patients undergoing orthopedic procedures of the lower extremeties are going to be studied. A modified Shamrock approach of the lumbar plexus is going to be used for postoperative analgesia, using an ultrasound-guided technique combined to a nerve stimulatior. The technique is going to be assessed as for accuracy, and safety. | Procedure: lumbar plexus block<br>* Patients undergoing orthopedic procedures of the lower extremeties are going to be studied. A modified Shamrock approach of the lumbar plexus is going to be used for postoperative analgesia, using an ultrasound-guided technique combined to a nerve stimulatior. The technique is going to be assessed as for accuracy, and safety.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time required to localize the lumbar plexus | The time (in secondes) required of this modified Shamrock method to localize the lumbar plexus in the interpsoas compartment in elderly-trauma patients undergoing orthopedic procedures of the lower extremeties. Imaging time will be calculated (time to obtain appropriate imaging of the plexus) as well as needling time (time to obtain appropriate needle placement on the plexus) | 10 minutes (from the begining of imaging procedure) (time in seconds to localize the plexus) | 
| Complications from lumbar plexus blockade | Safety of the modified Shamrock method of lumbar plexus blockade in elderly-trauma patients undergoing orthopedic procedures of the lower extremeties. All possible complications will be recorded (i.e. neurological complications, numbness, mobility disorder, haemmorhage, haematoma, e.t.c.) | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Postoperative pain relief 4 hours after completion of the block (visual analogue scale 0-10). A VAS score <4 is considered adequate. | 4 hours (visual analogue scale 0-10 at 4 hours postoperatively) |