Early Femoral Block in Elderly With Hip Fracture

  • End date
    Oct 23, 2022
  • participants needed
  • sponsor
    ASST Gaetano Pini-CTO
Updated on 24 January 2021
nerve block
femoral neck fracture


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.


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).

Condition HIP FRACTURE, hip fractures, broken hip
Treatment Control group, femoral nerve catheter, femoral group
Clinical Study IdentifierNCT03092466
SponsorASST Gaetano Pini-CTO
Last Modified on24 January 2021


Yes No Not Sure

Inclusion Criteria

Postoperative ICU admission
Patients with Hb < 8 mg/dl at admission

Exclusion Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note