Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02450045 |
| Other study ID # |
Pro00044335 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 2015 |
| Est. completion date |
January 2020 |
Study information
| Verified date |
March 2020 |
| Source |
University of Alberta |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Hip fractures (broken hips) are common in older people, particularly older women with fragile
bones, and usually occur with a simple fall from a standing height. In Canada, over 28,000
hip fractures occur every year, and approximately 900 occur in Edmonton. After a hip
fracture, up to 50% of those who survive their hip fracture do not recover to the same level
of activity that they had before breaking their hip. Managing pain with any broken bone is
very important. For patients with hip fracture, their older age and fragile health makes pain
management even more challenging. Many patients with a hip fracture have reduced ability to
think clearly before the fracture. Some patients who have no difficulty with thinking before
their hip fracture will become confused for a brief period after their hip fracture or can
develop permanent difficulties with thinking. A hip fracture will usually require an
operation, and choosing the right pain medication before and after the operation is important
since many pain medications make confusion more likely. Permanent difficulty with thinking is
a common reason for poor recovery after hip fracture. Our study will look at use of a nerve
block to manage pain before patients have their operation. A nerve block provides local pain
relief without requiring patients to take the medication by mouth (oral) or through an
intravenous (IV) route. A nerve block before surgery may reduce the amount of oral and IV
pain medication needed by the patient both before and after their operation but still provide
good pain control with less confusion. This could lead to better recovery and allow more
patients to return to living in the community rather than long-term care.
Description:
Background and rationale
Hip fracture is a common injury in older people, with over 28,000 hip fractures occurring
annually in Canada. Approximately 900 hip fractures occur in Edmonton each year. More than
90% of hip fractures result from simple low-energy falls. Many patients who survive do not
recover to pre-fracture functional levels and may require permanent long-term care.
The immediate goal of treatment is to control pain while preparing the patient for surgery;
greater than 95% of hip fracture patients are treated with surgery to restore mechanical
stability and manage pain. Pain after hip fracture has been associated with delirium,
depression, sleep disturbance, and decreased recovery. However, in the elderly population,
narcotics are also associated with similar side effects such as delirium, cardiovascular and
respiratory depression and nausea. This is complicated further in hip fracture patients, in
whom pre-existing dementia is common - up to 50% of patients will present with altered
cognition. Most studies that examine pain management interventions after hip fracture exclude
those with pre-existing dementia. Further research to determine the feasibility of including
subjects with cognitive impairment in pain management studies is needed.
Regional anaesthesia can reduce post-operative narcotic use. However, few randomized studies
have examined the impact of preoperative regional anesthesia on postoperative outcomes.
Effective pain management can affect long-term outcomes: poorly managed pain is associated
with delayed ambulation, pulmonary complications, and delayed hospital discharge. Our
previous work found limited evidence that nerve blocks may have benefits for hip fracture
patients. Other prospective studies have reported the effectiveness of single nerve blocks in
reducing narcotic use in Emergency rooms. Continuous preoperative femoral nerve blockade
(CFNB) offers the potential benefit of reducing pain in these often frail patients well
avoiding adverse outcomes such as delirium. Further work is needed to determine the
effectiveness, timing, and safety of a preoperative CFNB on preoperative and postoperative
outcomes in the frail hip fracture population, including those with cognitive impairment.
Study objectives
The primary objective is to determine the feasibility of a definitive randomized controlled
trial (RCT) that examines the effect of preoperative CFNB in patients with hip fracture,
including those with cognitive impairment. Specifically, the investigators will examine 1)
Eligibility/recruitment rates; 2) Treatment fidelity; 3) Outcome selection.
The secondary objective is to determine the impact of pre-operative CFNB in patients with hip
fracture on the following outcomes within five days of surgery: 1) Proportion of patients
with delirium and duration of delirium; 2) Daily pain levels; 3) Total narcotic utilization;
4) Proportion of patients mobilized on postoperative day 1; 4) Readiness for hospital
discharge; 5) Complications in hospital, including mortality.
Hypothesis
The investigators hypothesize that pre-operative CFNB will be feasible in this population and
will decrease: delirium frequency / duration, pain, and narcotic requirement; will increase
the number of patients mobilized on post-operative day 1; and reduce complications and time
to readiness for discharge.Study procedures
Research Framework: A complex intervention framework will be used to explore the impact of
preoperative CFNB in patients with hip fracture on both preoperative and early postoperative
outcomes. The work proposed will undertake initial steps to identify appropriate subjects and
assess feasibility and impact of the intervention.
Pilot Study Design: Inception cohort of 75 participants using a concurrent control group with
2:1 allocation of intervention and control subjects. This will allow comparison of outcomes
between groups as well as sub-analyses within the intervention group (n=50) to examine
treatment fidelity and potential confounding. Although the investigators may be under-powered
in this pilot study, they will determine the numbers needed for a future RCT. The proposed
sub-analyses will allow us to determine if those with cognitive impairment can be
appropriately treated with a CFNB and adequately assessed and if there is an optimal
preoperative time frame in which CFNB should be applied.
Intervention: Subjects who score ≥13 on the MMSE, consent to participate, and are recruited
within 20 hours of ward presentation will be allocated to receive pre-operative CFNB. Twenty
hours was selected as the maximum time that the CFNB could be delayed after presentation to
hospital and expect to have an impact on pain management based on anecdotal experience of our
Acute Pain Service (APS) team members. The APS will administer the CFNB using a standardized
protocol.
Usual Care (Control group): Subjects enrolled after 20 hours of hospital admission (due to
delays in obtaining consent) will be allocated to the control group provided that a CAM,
required on ward admission as per the hip fracture pathway, was done within 6 hours of ward
admission to assess baseline delirium. The investigators do not anticipate selection bias as
suitable numbers of patients who are consented before and after 20 hours of admission to the
ward should occur.
Femoral Nerve Blockade: The side of hip fracture is identified and marked. With the patient
lying supine, the groin is exposed and prepared with 2% chlorhexidine gluconate/70% isopropyl
alcohol. A 13-6 MHz high frequency linear ultrasound probe is placed just distal to the
lateral edge of the femoral crease and orientated parallel to the crease. The probe is then
moved medially, inferior and parallel to the femoral crease, to identify the common femoral
artery. The femoral nerve is then identified lateral to the artery and deep to fascia iliaca.
Two milliliters of 1% lidocaine is infiltrated subcutaneously at the lateral edge of the
probe using a 3 mL syringe and a 25G needle to provide anesthesia to the skin.
A 21G x 95 mm catheter-over-needle assembly is inserted 'in-plane' to the ultrasound probe
from the lateral edge of the probe and directed medially under direct visualization to the
target position - deep to the fascia iliaca, between the femoral nerve and iliopsoas muscle.
The spread of 5 mL dextrose 5% in water injected through the needle confirms correct
position. The catheter needle is removed, and the first dose of 20 mL local anesthetic
mixture (0.5% Ropivacaine and 0.125% Bupivacaine) is bolused through the catheter using a
syringe.
Immediately after, the catheter is secured with a Tegaderm dressing and then connected to an
infusion pump programmed to deliver a continuous 1 mL/hr infusion and 4 mL/hr bolus regime of
0.2% Ropivacaine. The infusion/bolus regime is continued until just prior to surgery, at
which point, it is discontinued and the catheter bolused with a further 20 mL of local
anesthetic mixture prior to catheter removal. Following the regional anesthetic intervention,
the subjects are returned to the Orthopaedic ward to await routine surgical care.
Surgery: Surgery within 24-48 hours of admission reduces morbidity and mortality after hip
fracture. Over 80% of patients at the UAH are treated within 48 hours of admission. Surgical
care will be determined by fracture pattern and patient factors as well perioperative
anaesthesia. Study allocation will not affect surgical priority. Both groups will receive
routine care pre- and postoperatively as per the clinical pathway, aside from the
intervention group receiving the CFNB preoperatively.
Data collection: Baseline data will consist of demographic (e.g., age, gender, residence),
medical (cognition (MMSE), delirium (CAM), comorbidities) data and pain using a Visual
Analogue Scale (VAS) for those without cognitive impairment and a validated non-verbal pain
scale for those with cognitive impairment. Preoperatively, research staff will collect
narcotic and non-narcotic analgesic consumption, CAM scores that are performed each shift
(i.e., 2 times/day). Pain at rest and with activity will be collected two times/day, between
9-10 am and again between 3-4 pm. During weekend hours, the APS team will collect pain
scores. Post-operative data collection will occur until postoperative day 5 or discharge,
whichever is sooner. Delirium and pain at rest and with activity will be assessed twice daily
as per the preoperative protocol. Narcotic and non-narcotic analgesic utilization will be
recorded. The research staff will record when subjects first mobilize (i.e., got up out of
bed) and subjects' readiness for discharge (as per the clinical pathway). Complications will
also be noted.
Analysis
The process evaluation will assist in determining: 1) Recruitment rate: All patients with hip
fracture admitted during the enrollment period will be screened to determine the recruitment
rate and generalizability of the cohort; 2) Treatment Fidelity: Defined as delivering the
intervention as it was intended, this will be determined by assessing a) the number of
Intervention subjects who received the CFNB as prescribed b) the impact of time to CFNB to
determine if an optimal preoperative window for the CFNB exists, c) the impact of cognitive
impairment on the intervention's effect and the ability to assess outcomes; 3) Outcome
Selection: The investigators will evaluate the following issues around outcomes- a) selecting
a responsive and appropriate primary outcome measure, b) determining the appropriate time to
measure the intervention's impact (i.e., at a single point in time or impact over time), c)
comparability of verbal and non-verbal pain assessment, d) completion rate for the clinical
pathway elements. The intervention evaluation will determine the impact of preoperative CFNB
by comparing outcomes between groups using T-tests and repeated measures analysis of variance
(ANOVA) for continuous variables and chi-square tests for categorical variables. Our primary
outcome measure for this evaluation will be comparison of delirium between groups using the
CAM.
Outcomes
The following standardized outcome measures will be used: Visual Analogue Scale (VAS) for
Pain Assessment - Pain at rest and activity will be measured using an 11-point VAS (0-10), a
reliable and valid method of measuring patient-reported pain. The Checklist of Non-verbal
Pain Indicators (CNPI) has been shown to be reliable and valid in the non-verbal assessment
of patients with hip fracture and cognitive impairment. The Confusion Assessment Method (CAM)
is able to distinguish between dementia and delirium and can detect delirium in the presence
of dementia. Narcotic Consumption - All narcotic medication will be recorded. The total
amount of narcotic used will be measured using a morphine equivalency scale with the
resulting equivalents totaled to give a single score reflecting the total narcotics used.
