Hip FracturesPhase 4NCT03588689
Continuous Fascia Iliaca Block for Acute Hip Fractures
A Phase 4 study testing Continuous fascia iliaca block and Ropivacaine in people with Hip Fractures and Neuromuscular Blockade, run by University of Saskatchewan at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures, Neuromuscular Blockade, Respiratory Morbidity
- What is being tested?
- Continuous fascia iliaca block and Ropivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 7 May 2018to 1 May 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Adults age greater than or equal to 65 years old with acute hip fracture
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Fascia Iliaca Block for Acute Hip Fractures: a Randomized Controlled Pilot Study
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.
Read the 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.
- Conditions
- Hip Fractures, Neuromuscular Blockade, Respiratory Morbidity, Delirium, Fascia Iliaca Block, Pain
- Being tested
- Continuous fascia iliaca block, Ropivacaine
- Keywords
- hip fracture, fascia iliaca block, continuous fascia iliaca block, neuromuscular blockade
- Medical subject headings
- Hip Fractures, Delirium, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous fascia iliaca blockProcedure or surgery
Regional nerve block performed under ultrasound guidance. A catheter will be left in place to allow ongoing infusion of local anesthetic.
RopivacaineDrug
Ropivacaine local anesthetic will be used for the fascia iliaca block
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment | No intervention | Patients in this group will receive standard treatment orders which include a combination of opioids, NSAIDs, acetaminophen, and other adjuncts for analgesia. |
| Continuous fascia iliaca block | Experimental | The cFIB group will receive an ultrasound guided cFIB and standard treatment orders as backup in the event of block failure.
The cFIB group will receive an initial bolus of 40 cc of 0.25% Ropivacaine followed by an infusion of 8 cc/hr until the time of surgery. Immediately pre-operatively, the anesthesiologist performing the case will bolus the catheter 40 cc of 0.25% ropivacaine and discontinue the catheter. Receives: Procedure: Continuous fascia iliaca block; Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory complications
Use of supplemental oxygen, need for positive pressure ventilation, decreased oxygen saturations, radiographic evidence of atelectasis or pneumonia
Measured: During hospital stay, up to 1 month
Secondary outcomes (5)
Pain score
Subjective pain score on 1-10 visual analog scale in supine, semi-recumbent, upright positions, and with active movement
Measured: During hospital stay, up to 1 month
Opioid side effects
Incidence of nausea, vomiting, pruritus, constipation, and urinary retention will be recorded
Measured: During hospital stay, up to 1 month
30 day mortality
Status, living or deceased, at 30 days post op
Measured: Will be collected from hospital record, at up to 3 months after enrolment.
Delirium
CAM-ICU scoring system will be used daily to measure delirium
Measured: During hospital stay, up to 1 month
Post op length of stay
Will be measured as number of days in hospital from date of admission until ready for discharge
Measured: During hospital stay, up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start7 May 2018
- Primary completion31 Mar 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a prospective randomized controlled non-blinded pilot study.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Churao Yang, University of Saskatchewan
- Investigators
- Brian Brownbridge, MD, Principal investigator, University of SaskatchewanChurao Yang, MD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588689
- Sponsor's protocol ID
- Bio 17-267
- Status last verified
- May 2019
- First submitted
- 27 Apr 2018
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not be sharing individual participant data.
Publications
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.
PubMed 33238043
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Fascia Iliaca Block for Acute Hip Fractures: a Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT03588689
- Acronym / sponsor ID
- Bio 17-267
- Conditions
- Hip Fractures, Neuromuscular Blockade, Respiratory Morbidity, Delirium, Fascia Iliaca Block, Pain
- Keywords
- hip fracture, fascia iliaca block, continuous fascia iliaca block, neuromuscular blockade
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 7 May 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 17 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a prospective randomized controlled non-blinded pilot study.
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment | No intervention | –Patients in this group will receive standard treatment orders which include a combination of opioids, NSAIDs, acetaminophen, and other adjuncts for analgesia. |
| Continuous fascia iliaca block | Experimental | Procedure: Continuous fascia iliaca block, Drug: RopivacaineThe cFIB group will receive an ultrasound guided cFIB and standard treatment orders as backup in the event of block failure. The cFIB group will receive an initial bolus of 40 cc of 0.25% Ropivacaine followed by an infusion of 8 cc/hr until the time of surgery. Immediately pre-operatively, the anesthesiologist performing the case will bolus the catheter 40 cc of 0.25% ropivacaine and discontinue the catheter. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Adults age greater than or equal to 65 years old with acute hip fracture
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous fascia iliaca blockRegional nerve block performed under ultrasound guidance. A catheter will be left in place to allow ongoing infusion of local anesthetic. | Procedure or surgery | Continuous fascia iliaca block |
| RopivacaineRopivacaine local anesthetic will be used for the fascia iliaca block | Drug | Continuous fascia iliaca block |
Primary outcome
Respiratory complications
Time frame: During hospital stay, up to 1 month
Use of supplemental oxygen, need for positive pressure ventilation, decreased oxygen saturations, radiographic evidence of atelectasis or pneumonia
5 secondary outcomes
Pain score
Time frame: During hospital stay, up to 1 month
Opioid side effects
Time frame: During hospital stay, up to 1 month
30 day mortality
Time frame: Will be collected from hospital record, at up to 3 months after enrolment.
Delirium
Time frame: During hospital stay, up to 1 month
Post op length of stay
Time frame: During hospital stay, up to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- Derived from this study: PubMed 33238043Guay 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.
- Individual participant dataSharing planned: No. We will not be sharing individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Brownbridge, MD principal investigator
University of Saskatchewan
Churao Yang, MD principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Continuous fascia iliaca block and Ropivacaine in people with Hip Fractures and Neuromuscular Blockade, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory complications (time frame: During hospital stay, up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03588689, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2019; AzTrials last refreshed its copy on 6 Nov 2026.