Clinical trial NCT03588689: Continuous Fascia Iliaca Block for Acute Hip Fractures
Official title: Continuous Fascia Iliaca Block for Acute Hip Fractures: a Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hip Fractures
Neuromuscular Blockade
Respiratory Morbidity
Delirium
Fascia Iliaca Block
Pain
Keywords: hip fracture
fascia iliaca block
continuous fascia iliaca block
neuromuscular blockade
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a prospective randomized controlled non-blinded pilot study.
Primary purpose: TREATMENT

Brief summary: Hip fractures are a major cause of morbidity and mortality in the elderly with over 30,000 hip fractures occuring in Canada annually and over 1300 in Saskatchewan. The estimated cost associated with hip fractures is over $600 million nationally and 28 million dollars in Saskatchewan. Hip fractures cause a great deal of pain and immobility and are mainly treated with surgical fixation. In the perioperative period, hip fracture patients are treated mainly with opioids and other adjuncts such as NSAIDS and acetaminophen. Opioid consumption in the elderly population can predispose to delirium and respiratory complications such as atelectasis, respiratory depression, and pneumonia.

Fascia iliaca blocks have been shown to be an effective mode of analgesia for patients with hip fractures, but are underutilized for varying reasons including culture of practice, expertise with performing the block, and having a dedicated service to do so.

This study aims to compare the efficacy of fascia iliaca blocks to standard treatment (opioids) in the management of pain in hip fracture patients with a particular focus on outcomes such as the incidence of delirium, respiratory complications, and length of stay in hospital. Our idea is that if we can reduce the amount of opioids these patients receive then they will have improved pain control, fewer respiratory complications, earlier time to mobilizing, and shorter hospital stays. As far as we are aware this relation has not been well studied.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Respiratory complications
timeFrame: During hospital stay, up to 1 month
Secondary outcomes:
measure: Pain score
timeFrame: During hospital stay, up to 1 month
measure: Opioid side effects
timeFrame: During hospital stay, up to 1 month
measure: 30 day mortality
timeFrame: Will be collected from hospital record, at up to 3 months after enrolment.
measure: Delirium
timeFrame: During hospital stay, up to 1 month
measure: Post op length of stay
timeFrame: During hospital stay, up to 1 month
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Brian Brownbridge, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Saskatchewan
name: Churao Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.