Continuous Fascia Iliaca Block for Acute Hip Fractures

This study is a prospective randomized controlled non-blinded pilot study.

Recruitment and Randomization: fifty adult patients with hip fractures for surgical fixation presenting to Royal University Hospital (RUH), Saskatoon, Saskatchewan, will be recruited. The exclusion criteria are:

• American Society of Anesthesiologists (ASA) score >3
• Other injuries that interfere with block positioning and assessment of pain
• Local anesthetic allergy
• Open fracture
• Moderate to severe pre-operative delirium (interfering with consent and assessment)
• Sepsis at site of injection
• Anticoagulation with warfarin or anti-Xa inhibitors
• Age less than 65 years

Patients will be randomized into one of two research arms: Continuous Fascia Iliaca block (cFIB) vs standard treatment (opioids). It is important to note here is that patients receiving cFIBs will have standard treatment orders available in the event of block failure, and opioid consumption will be monitored.

Methods:

Patients with hip fractures presenting to RUH will be approached by a member of the study team for consent to participate in the study. After consent is obtained patients will be randomised to either arm of the study group. The cFIB group will receive an ultrasound guided cFIB and standard treatment orders as backup in the event of block failure. The standard treatment group will receive only standard treatment orders which include a combination of opioids, NSAIDS, acetaminophen, and other adjuncts for analgesia.

The CFIB group will receive an initial bolus of 40 cc of 0.125% Ropivacaine followed by an infusion of 10 cc/hr of 0.2% ropivacaine until the time of surgery. Immediately pre-operatively, the anesthesiologist performing the case will bolus the catheter with 40 cc of 0.125% ropivacaine and discontinue the catheter.

Data collection: Demographic and epidemiologic data will be collected for both groups at the time of recruitment. Patients will be followed from the time of enrollment until the time of discharge from hospital. A member of the study team will visit daily and assess the patients for delirium using the Confusion Assessment Method (CAM)-ICU tool, which is a validated delirium assessment tool. Pain scores will be obtained after block insertion and twice a day until surgical fixation takes place. Pain scores will be assessed in the supine, semi recumbent, and upright position, and with active movement. Opioid consumption will be recorded as morphine equivalents for the entire length of hospital stay. The incidence of side effects of opioids will be recorded including : Nausea, vomiting, pruritis, constipation, and urinary retention.

The length of time from surgery until ready to discharge will be recorded.

It is difficult to directly measure respiratory complications. As a surrogate for respiratory complications the following data will be collected:

• Oxygen requirements pre and post operatively
• Pre and post operative need for positive pressure ventilation (CPAP, BiPAP)
• Radiographic evidence of atelectasis or pneumonia
• Trends in oxygen saturation as measured by pulse oximetry Data collection is projected to be completed by July 1st 2018

Data analysis: Parametric data will be reported as a mean +/- standard deviation, along with confidence intervals. Means will be used to estimate effect size and these values will then be used in power calculations and sample size estimation for future studies. In addition, the unpaired t-test will be used to test for significant difference between groups. The incidence of adverse events will be recorded and presented with descriptive statistics. Data analysis is projected to be completed by October 2018

Significance:

Fascia Iliaca blocks have already been shown to improve pain in hip fracture patents. Our theory is that if we can effectively manage pain with cFIBs we can reduce the amount of opioids patients receive in the perioperative period. This could lead to reduced complications from opioids, improved patient positioning, improved patient mobility, and earlier time to discharge which would have a great impact on patient experience and cost of care.

Inclusion criteria

• Adults age greater than or equal to 65 years old with acute hip fracture

Exclusion criteria

• ASA greater than or equal to 4
• Open fractures
• Other concomitant injuries that may interfere with positioning or pain scores
• Local anesthetic allergy
• Delirium at the time of consent
• Pre-existing cognitive impairment
• Infection at the site of injection for cFIB
• Previous surgery in femoral triangle
• Warfarin or Anti-Xa inhibitor use
• Long-term opioid use
• Intraoperative complications