Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)NCT03525977
Impact of Fascia Iliaca Block in Hip Fracture Patients
A study testing Fascia iliaca block arm in people with Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures), run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
Trial summary
The study is a prospective randomized examining the impact of fascia iliaca block on perioperative pain control and post operative ambulation in patients with hip fractures. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)
- What is being tested?
- Fascia iliaca block arm
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2018to 1 May 2019
- Phase
- Interventional
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with femoral neck and intertrochanteric hip fractures
- At least 18 years of age
- Require operative management
Who cannot join
- Poly-trauma patients
- Pathologic fractures
- Patient who required revision procedures
- Patients with chronic opioid use
- Patients with a clinical status that precludes verbal pain assessment such as dementia, head injuries, and unwillingness to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Fascia Iliaca Block on Pain Outcomes and Opioid Consumption for Hip Fracture Patients-A Prospective, Randomized Study
The study is a prospective randomized examining the impact of fascia iliaca block on perioperative pain control and post operative ambulation in patients with hip fractures.
Read the detailed description
Regional anesthesia is an important element of multimodal pain control regimen for surgical patients. Recently, regional anesthesia using a fascia iliaca block (FIB) to help treat pain in patients who present with hip fractures has been gaining popularity and has been incorporated as part of a multi-modal pain control protocol in many centers. It is commonly offered in addition to oral and intravenous medications to help patients deal with pain in the perioperative period. The block is done by an anesthesiologist under anesthesia using ultrasound guidance. We propose a prospective, randomized study evaluating the efficacy of the FIB as an adjunct in the pre-operative or postoperative period for pain control as measured by visual analog scale (VAS) scores and morphine equivalent dosing (MED), as well as its efficacy in promoting patient participation in physical therapy postoperatively in patients who present with hip fractures. We hypothesize that those patients who receive FIBs will report lower VAS scores as well as decreased narcotic requirement at all time points; and have improved participation in therapy when measured by ambulation distance.
- Being tested
- Fascia iliaca block arm
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascia iliaca block armProcedure or surgery
Also called FIB
The fascia iliaca block will be performed by the anesthesiologist on call
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients in the control arm will receive pain control via traditional oral and intravenous pain medications such as opioids and non-steroidal anti-inflammatory medication as needed. |
| Fascia iliaca block | Experimental | Patients in the intervention arm will receive the regional fascia iliaca block performed by the anesthesiologists on call. Receives: Procedure: Fascia iliaca block arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
Visual analog scale scores (from 0-10 with 0 being no pain and 10 being the worst pain)
Measured: Pre operatively
Pain medication requirement
Morphine equivalent dosing
Measured: Pre operatively
Pain level
Visual analog scale scores (from 0-10 with 0 being no pain and 10 being the worst pain)
Measured: Four hours after surgery
Pain medication requirement
Morphine equivalent dosing
Measured: Four hours after surgery
Pain level
Visual analog scale scores (from 0-10 with 0 being no pain and 10 being the worst pain)
Measured: One day after surgery
Pain medication requirement
Morphine equivalent dosing
Measured: One day after surgery
Pain level
Visual analog scale scores (from 0-10 with 0 being no pain and 10 being the worst pain)
Measured: Two days after surgery
Pain medication requirement
Morphine equivalent dosing
Measured: Two days after surgery
Pain level
Visual analog scale scores and morphine equivalent dosing
Measured: Three days after surgery
Pain medication requirement
Morphine equivalent dosing
Measured: Three days after surgery
Secondary outcomes (1)
Ambulation distance
Ambulation distance with physical therapy post op
Measured: Two days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start20 Feb 2018
- Primary completion1 May 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 Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center, El Paso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai P. Nguyen, Texas Tech University Health Sciences Center, El Paso
- Investigators
- Mai Nguyen, MD, Principal investigator, Texas Tech University Health Sciences Center, El Paso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03525977
- Sponsor's protocol ID
- E18046
- Status last verified
- May 2019
- First submitted
- 3 May 2018
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Fascia Iliaca Block on Pain Outcomes and Opioid Consumption for Hip Fracture Patients-A Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT03525977
- Acronym / sponsor ID
- E18046
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences Center, El PasoUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 16 May 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.
The study is a prospective randomized examining the impact of fascia iliaca block on perioperative pain control and post operative ambulation in patients with hip fractures.
Detailed description
Regional anesthesia is an important element of multimodal pain control regimen for surgical patients. Recently, regional anesthesia using a fascia iliaca block (FIB) to help treat pain in patients who present with hip fractures has been gaining popularity and has been incorporated as part of a multi-modal pain control protocol in many centers. It is commonly offered in addition to oral and intravenous medications to help patients deal with pain in the perioperative period. The block is done by an anesthesiologist under anesthesia using ultrasound guidance. We propose a prospective, randomized study evaluating the efficacy of the FIB as an adjunct in the pre-operative or postoperative period for pain control as measured by visual analog scale (VAS) scores and morphine equivalent dosing (MED), as well as its efficacy in promoting patient participation in physical therapy postoperatively in patients who present with hip fractures. We hypothesize that those patients who receive FIBs will report lower VAS scores as well as decreased narcotic requirement at all time points; and have improved participation in therapy when measured by ambulation distance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients in the control arm will receive pain control via traditional oral and intravenous pain medications such as opioids and non-steroidal anti-inflammatory medication as needed. |
| Fascia iliaca block | Experimental | Procedure: Fascia iliaca block armPatients in the intervention arm will receive the regional fascia iliaca block performed by the anesthesiologists on call. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with femoral neck and intertrochanteric hip fractures
- At least 18 years of age
- Require operative management
Key exclusion criteria (5 listed)
- Poly-trauma patients
- Pathologic fractures
- Patient who required revision procedures
- Patients with chronic opioid use
- Patients with a clinical status that precludes verbal pain assessment such as dementia, head injuries, and unwillingness to participate.
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 |
|---|---|---|
| Fascia iliaca block armAlso: FIBThe fascia iliaca block will be performed by the anesthesiologist on call | Procedure or surgery | Fascia iliaca block |
Primary outcome
Pain level
Time frame: Pre operatively
Visual analog scale scores (from 0-10 with 0 being no pain and 10 being the worst pain)
Pain medication requirement
Time frame: Pre operatively
Morphine equivalent dosing
Pain level
Time frame: Four hours after surgery
Visual analog scale scores (from 0-10 with 0 being no pain and 10 being the worst pain)
Pain medication requirement
Time frame: Four hours after surgery
Morphine equivalent dosing
Pain level
Time frame: One day after surgery
Visual analog scale scores (from 0-10 with 0 being no pain and 10 being the worst pain)
Pain medication requirement
Time frame: One day after surgery
Morphine equivalent dosing
Pain level
Time frame: Two days after surgery
Visual analog scale scores (from 0-10 with 0 being no pain and 10 being the worst pain)
Pain medication requirement
Time frame: Two days after surgery
Morphine equivalent dosing
Pain level
Time frame: Three days after surgery
Visual analog scale scores and morphine equivalent dosing
Pain medication requirement
Time frame: Three days after surgery
Morphine equivalent dosing
1 secondary outcome
Ambulation distance
Time frame: Two days after surgery
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 28 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.
Related trials for Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)
RecruitingObservational study
Cohort Study on the Prognosis and Influencing Factors in Elderly Patients With Hip Fractures in Multicenter of China
Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)
Not yet recruiting
FICB for Hip Fracture Pain in Elderly
Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures), Postoperative Pain
Not yet recruitingObservational study
Improving Shared DECISion-making in oldEr Hip Fracture Patients Living With Frailty
Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures), Hip Fractures (ICD-10 72.01-72.2)
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.
Mai Nguyen, MD principal investigator
Texas Tech University Health Sciences Center, El Paso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fascia iliaca block arm in people with Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures), run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
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 5 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 28 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 United States. 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.
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?
Pain level (time frame: Pre operatively). The study lists 10 primary outcomes in all. 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 NCT03525977, 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 28 May 2019.