Early Femoral Block in Elderly With Hip Fracture

April 14, 2023 updated by: Gianluca Cappelleri, ASST Gaetano Pini-CTO

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milano
      • Milan, Milano, Italy, 20122
        • Recruiting
        • ASST Gaetano Pini-CTO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: femoral group
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
femoral block with Ropivacaine 0.75% (15 ml) in femoral catheter
Drug: femoral group
femoral block with Ropivacaine 0.75% (15 ml) in femoral catheter
Other Names:
  • Ropivacaine
Placebo Comparator: control group
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
femoral block with Ropivacaine 0.75% (15 ml) in femoral catheter
Drug: control group
infusion of saline solution (15ml) in femoral catheter
Other Names:
  • Saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of delirium
Time Frame: From hospital admission to home discharge, an average of 14 days
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
Time Frame: From hospital admission to home discharge, an average of 14 days
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)
Time Frame: From hospital admission to home discharge, an average of 14 days
Length of hospital stay
From hospital admission to home discharge, an average of 14 days
Postoperative complications
Time Frame: From hospital admission to home discharge, an average of 14 days
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
Time Frame: 1,3,12 months postoperative
mortality
1,3,12 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ASST Gaetano Pini-CTO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2017

Primary Completion (Anticipated)

December 23, 2023

Study Completion (Anticipated)

December 23, 2024

Study Registration Dates

First Submitted

February 22, 2017

First Submitted That Met QC Criteria

March 21, 2017

First Posted (Actual)

March 28, 2017

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOGPGC11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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