Hip FractureNCT02804542
Fascia Iliaca Blocks and Pre-operative Opioid Requirements in Hip Fracture Patients
An observational study of Hip Fracture, run by Corewell Health West.
Trial summary
The purpose of this study is to determine if non-continuous local anesthetic fascia iliaca blocks performed in the emergency department are effective for preoperative analgesia in hip fracture patients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fracture
- What is being tested?
- Observational and Retrospective review
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- 11 Aug 2016to May 2019
- Phase
- Observational
- 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
Study population: All patients >65 years of age presenting to Spectrum Health Butterworth hospital with low-energy hip fractures (displaced and non-displaced femoral neck, pertrochanteric-type including subtrochanteric extension) will be screened for the study.
Who may be able to join
- low energy femoral neck and pertrochanteric-type hip fractures
- age 65+
- intact cognition upon admission and ability to provide written informed consent
Who cannot join
- pathologic fractures (tumor)
- high energy fractures
- concomitant fractures besides hip fractures
- chronic home opioid exposure prior to hospitalization
- moderate to severe dementia
- pre-fracture hospitalization
- time from arrival to block >6 hours
- time from arrival to OR <6 hours or >48 hours
About this study
Official title: Pre-operative Fascia Iliaca Blocks and Opioid Requirements in Hip Fracture Patients
The purpose of this study is to determine if non-continuous local anesthetic fascia iliaca blocks performed in the emergency department are effective for preoperative analgesia in hip fracture patients. Investigators hypothesize that patients with these blocks will have lower opioid requirements than patients in a historical group in whom blocks were not performed.
- Conditions
- Hip Fracture
- Being tested
- Observational, Retrospective review
- Keywords
- fascia iliaca blocks
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Retrospective reviewOther
| Study group | Role | What they receive |
|---|---|---|
| Fascia Iliaca Block Cohort | Prospective patients receiving fascia iliaca blocks A prospective Observational study of Hip fracture patients that are offered fascia iliaca blocks as standard of care in the ED. Receives: Other: Observational | |
| Retrospective Control Cohort | No fascia iliaca block performed A retrospective review will be done of hip fracture patients that did not receive fascia iliaca blocks (before fascia iliaca blocks being offered in the ED as standard of care). Receives: Other: Retrospective review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Pre-op IV Morphine Equivalents (TIVME)
IV morphine equivalent dosing pre-operatively
Measured: From Date of admission until date of surgery, approximately 48 hours
Secondary outcomes (2)
Mean Pre-op Pain Score
Mean patient-reported pain score
Measured: From Date of admission until date of surgery, approximately 48 hours
Length of Hospital Stay (LOS)
Measured: Through study completion, approximately 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study start11 Aug 2016
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health West
- Sponsor type
- University, hospital or other
- Collaborators
- Grand Rapids Medical Education Partners
- Responsible party
- Sponsor
- Investigators
- Matthew Flannigan, MD, Principal investigator, ECS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804542
- Sponsor's protocol ID
- 2016-160
- Status last verified
- Sep 2023
- First submitted
- 1 Jun 2016
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Fascia Iliaca Blocks and Opioid Requirements in Hip Fracture Patients
- ClinicalTrials.gov ID
- NCT02804542
- Acronym / sponsor ID
- 2016-160
- Conditions
- Hip Fracture
- Keywords
- fascia iliaca blocks
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Corewell Health WestUniversity, hospital or other
- Collaborators
- Grand Rapids Medical Education Partners
- Study start
- 11 Aug 2016 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 17 Jun 2016 (estimated)
- 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.
The purpose of this study is to determine if non-continuous local anesthetic fascia iliaca blocks performed in the emergency department are effective for preoperative analgesia in hip fracture patients. Investigators hypothesize that patients with these blocks will have lower opioid requirements than patients in a historical group in whom blocks were not performed.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fascia Iliaca Block Cohort | – | Other: ObservationalProspective patients receiving fascia iliaca blocks A prospective Observational study of Hip fracture patients that are offered fascia iliaca blocks as standard of care in the ED. |
| Retrospective Control Cohort | – | Other: Retrospective reviewNo fascia iliaca block performed A retrospective review will be done of hip fracture patients that did not receive fascia iliaca blocks (before fascia iliaca blocks being offered in the ED as standard of care). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All patients >65 years of age presenting to Spectrum Health Butterworth hospital with low-energy hip fractures (displaced and non-displaced femoral neck, pertrochanteric-type including subtrochanteric extension) will be screened for the study.
Key inclusion criteria (3 listed)
- low energy femoral neck and pertrochanteric-type hip fractures
- age 65+
- intact cognition upon admission and ability to provide written informed consent
Key exclusion criteria (8 listed)
- pathologic fractures (tumor)
- high energy fractures
- concomitant fractures besides hip fractures
- chronic home opioid exposure prior to hospitalization
- moderate to severe dementia
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 |
|---|---|---|
| Observational | Other | Fascia Iliaca Block Cohort |
| Retrospective review | Other | Retrospective Control Cohort |
Primary outcome
Total Pre-op IV Morphine Equivalents (TIVME)
Time frame: From Date of admission until date of surgery, approximately 48 hours
IV morphine equivalent dosing pre-operatively
2 secondary outcomes
Mean Pre-op Pain Score
Time frame: From Date of admission until date of surgery, approximately 48 hours
Length of Hospital Stay (LOS)
Time frame: Through study completion, approximately 5 days
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 22 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Matthew Flannigan, MD principal investigator
ECS
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fracture, run by Corewell Health West.
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 3 inclusion and 8 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 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Total Pre-op IV Morphine Equivalents (TIVME) (time frame: From Date of admission until date of surgery, approximately 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2023.