Early Femoral Block in Elderly With Hip Fracture

Study Overview
=================
Brief Summary
-----------------
Assess if the addition of an early femoral nerve block (performed within 2 hours from the admission in emergency department through a femoral nerve catheter) in the elderly patients (> 70 years) with hip fracture, reduces the incidence of postoperative delirium assessed by CAM 3Ds test, compared to the traditional systemic pain therapy.

Detailed Description
-----------------
In the Emergency Department (ED) all the patients with a diagnosis of femoral neck fracture that have completed the instrumental tests, will receive 0,5 mL/kg/h infusion of physiologic solution started through an indwelling IV catheter sited in the forearm at the opposite side of the fracture. Afterwards the orthopedic surgeon will assess whether the patient can be part of the study, and after having explained to the patient the study and obtaining written informed consent from each individual he will call the anesthesiologist to perform the cognitive tests. The questionnaires will be short test lasting a few minutes (5 to 10 min): the Mini Cog Test and the Confusion Assessment Method (CAM 3D S) run in its shortened form (14). This questionnaire, validated for the early detection of mental status changes, can be filled by the operator based on the answers provided by the patient during the execution of the Mini Cog test. If the tests did not highlight any cognitive impairment, the anesthesiologist will proceed to the placement of a femoral nerve catheter with the ultrasound-guided technique. The catheters will be placed using direct US visualization. A hyperechoic needle will be inserted (e-cath 51x83mm, Pajunk®, Germany) at the inguinal ligament lateral to the artery. The needle is advanced until the tip is adjacent to the nerve inside the fascia. Then, 5 mL of saline solution is injected to make the advancement of the catheter easier. The catheter will be placed medially to the nerve and secured by taping it to the skin using its own kit. The catheter will be used for postoperative analgesia in all patients. After that, using a computer-generated of random sequence number, the patients will be divided in two groups in a randomized manner as follow: Group 1 will receive 15 ml of a Ropivacaine 0,75% solution through the femoral catheter (femoral group = 300 Patients). Group 2 will receive, through the femoral catheter, the administration of an equivalent volume (15 ml) of a saline solution (Control group = 300 Patients). Randomization will be managed by a Monitor of the propose center. The Monitor will be a person skill in clinical trials management not involve in the clinical activity. In emergency room, after the enrollment procedures will be complete, a nurse not involve in further patient management call by phone the Monitor in order to achieve both randomization number and group. At this point, following the monitor instruction, this nurse will prepare a 20ml syringe with the studied solution: Ropivacaine 0.75% or Saline. The syringe will be identified by a code including patient name initials and the randomization number. This syringe will be pose by hand to the anesthetist at the end of the catheter placement in order to be injected. The group will be reveal by the Monitor only at the end of all enrollments. The enrollments will have to be completed within 2 hours from patient arrival in ED. Yet, the surgery will take place within 48 hours from arrival at the hospital. The patient, after the placement of the catheter, will be evaluated once a day by an operator not involved in anesthetic procedures and unaware of the patient group. In the operating room standard monitoring will be used, including noninvasive arterial blood pressure, heart rate, and pulse oximetry. In both groups it will be run a new femoral nerve block through the catheter placed about before using 15 ml of 1% Ropivacaine solution. At this point all the patients will be placed in the lateral position, with the side to be operated up, and the anesthesiologist will proceed performing a spinal anesthesia (interspaces L2-L3, L3-L4) with 12 mg of plan Levobupivacaine 0.5% injected through a 25 Gauge atraumatic needle. Data on the duration of the intervention, intra- and postoperative bleeding, hypotension, and any significant hemodynamic changes (30% more or less of baseline) will be recorded. Each patient will received an analgesic systemic therapy. This will begun after the admission of the patient in ED and will continue in the postoperative period. In all center the analgesic therapy protocol is: Acetaminophen 1g x 3 IV, and Tramadol 0.5 mg/kg IV (maximum 200 mg per day) if NRS> 3. Postoperatively, all patients will also receive a local anesthetic infusion (Ropivacaine 0.2%) through an electronic pump connected to the femoral catheter (basal rate 6 ml/h, bolus 2 ml, lock out 20 minutes) and continued for the first 48 postoperative hours.Preoperative evaluations include monitoring and recording of the non invasive blood pressure (PA), heart rate (HR) and peripheral oxygen saturation (SpO2), NRS for pain control and the demand for rescue Tramadol. The same parameters will be recorded every 24 hours postoperatively until discharge. It will be also recorded the occurrence of any postoperative complication (nausea, vomiting, significant hemodynamic changes, sepsis etc). During postoperative assessments will also be carried out the previously described cognitive tests (Mini Cog and 3D CAM) at 24 48, 72, 96 hours after surgery and at home discharge. Furthermore the elapsed time between the admission of the patient in ED and the conclusion of enrollment (end of catheter placement and local anesthetic or Saline injection through the catheter) will be recorded, as well as the time of surgery and the home discharge. The discharge criteria included patient mobilization (both ability to maintain sitting and stand up position), hemodynamic stability and stable hemoglobin, NRS <4 with oral analgesics, and absence of severe alteration of the cognitive state. All patients whose surgery is delayed more than 48 hours from the arrival in ED will be excluded. After home discharge all patients will be contacted by phone at month 1, 3 and 12 to assess complications and mortality. The enrollment will take for a minimum of 1 year and a maximum of two years (to complete the follow up).

Official Title
-----------------
A Prospective, Randomized, Double-blind, Multicenter Trial on the Effects of the Early Femoral Nerve Block in Elderly With Hip Fracture

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

Intervention / Treatment
-----------------
* Procedure: femoral nerve catheter
* Drug: femoral group
* Drug: control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged >70 years with femoral neck fracture, and admission in ED from Monday to Friday (from 8.00 am to 20.00 pm) American society of anesthesiologists (ASA) Physical status classification I-III Signed informed consent Exclusion Criteria: ASA>3 Contraindications to the regional anesthesia Patients allergic to one or more drugs used in the study Patients who are unable or refuse to provide informed consent Patients who show a cognitive impairment or signs of confusion or delirium already on arrival in ED Patients with access to ED Outside the times set in the inclusion criteria Postoperative ICU admission Patients with Hb < 8 mg/dl at admission

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: femoral group<br>Group 1: placement of a femoral nerve catheter plus femoral block with 15 ml of a Ropivacaine 0,75% solution through the femoral catheter | Procedure: femoral nerve catheter<br>* femoral block with Ropivacaine 0.75% (15 ml) in femoral catheter<br>Drug: femoral group<br>* femoral block with Ropivacaine 0.75% (15 ml) in femoral catheter<br>* Other names: Ropivacaine;|
| Placebo Comparator: control group<br>Group 2: placement of a femoral nerve catheter plus the administration of an equivalent volume (15 ml) of a saline solution through the femoral catheter | Procedure: femoral nerve catheter<br>* femoral block with Ropivacaine 0.75% (15 ml) in femoral catheter<br>Drug: control group<br>* infusion of saline solution (15ml) in femoral catheter<br>* Other names: Saline solution;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of delirium | Assess if the addition of an early femoral nerve block (performed within 2 hours from the admission in emergency department) in the elderly patients (> 70 years) with hip fracture, reduces the incidence of postoperative delirium assessed by CAM 3Ds test, compared to the traditional systemic pain therapy. | From hospital admission to home discharge, an average of 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative pain | Perioperative pain (NRS) after femoral nerve block in elderly | From hospital admission to home discharge, an average of 14 days | 
| Length of hospital stay (LOS) | Length of hospital stay | From hospital admission to home discharge, an average of 14 days | 
| Postoperative complications | nausea, vomiting, sepsis, cardiac ischemia events, pulmonary disease | From hospital admission to home discharge, an average of 14 days | 
| Mortality at 1,3,12 months after surgery | mortality | 1,3,12 months postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
femoral nerve block, elderly patient, cognitive impairment, hip fracture, regional anesthesia