Hip FracturesNCT03609645
Optimization of Analgesia for Hip Fracture Patients
A study testing Fascia iliaca block and Femoral articular branches block(FAB) in people with Hip Fractures, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Hip Fracture is a common orthopedic emergency in elderly people, which causes moderate to severe pain. Until now, different methods of pain treatment have been used, including pain-killer medication, which given in to the vein, and a nerve block.. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Fascia iliaca block and Femoral articular branches block(FAB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 19 Feb 2019to Jan 2020
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA Physical Status I-III
- 60 years old or older
- BMI 18-40
- Scheduled for hip fracture surgical fixation
Who cannot join
- Bilateral hip fracture
- Lack of mental ability to provide informed consent
- Pre-existing neuropathic pain or sensory disorders of the surgical limb
- Contraindication to regional anesthesia (Intolerance to the study drugs, bleeding diathesis, coagulopathy, malignancy or infection at the site of the block)
- Chronic opioid use defined as >30 mg of daily oral morphine equivalents
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Zhi-bin Wang, 9052323369
About this study
Official title: Optimization of Analgesia for Hip Fracture: Femoral and Obturator Articular Branch Block vs. Fascia Iliaca Block. A Double-blind, Randomized- Controlled Trial.
Hip Fracture is a common orthopedic emergency in elderly people, which causes moderate to severe pain. Until now, different methods of pain treatment have been used, including pain-killer medication, which given in to the vein, and a nerve block.. A nerve block is the defined as injection of a freezing/numbing medication (local anesthetic) around the nerve area in order to stop pain.
Painkiller medications by themselves are not enough to stop pain, especially the pain that start with movement.
Read more
At the Toronto Western hospital, patients with hip fracture will generally receive a fascia iliac block (FIB) within 24 hours of hospital admission as a standard of care.
Fascia iliaca block is a nerve block done by injecting local anestheticat the level of the groin. This done to provide pain relief and is done either in the emergency room or in the inpatient area.
Studies have shown that nerves supplying other areas in the hip may be blocked to relive hip pain fracture.
Additional to this method, there is a newer type of nerve block, called the femoral articular branch block (FAB) that aim to block the nerves supplying the hip joint.
This new block has been described based on better understanding of the anatomy of the nerves that control hip pain. This block consists on an injection in the groin at a similar location as the Fascia iliaca block except that the needle has to go slightly deeper (by a few centimeters) to reach a better target.
Based on the current understanding on anatomy it is possible that this new technique may provide better pain control than a Fascia Iliaca Block.
The purpose of the study is to investigate the degree of pain relief achieved by the two different nerve block techniques: 1) Fascia iliaca block (FIB) and 2) Femoral and AON articular branches block (FAB).
Read the detailed description
The anterior hip joint is innervated by articular branches from the femoral nerve (FN), the obturator nerve (ON) and the accessory obturator nerve (AON). The posterior and inferior parts of the hip joint capsule are innervated by the sacral plexus via a) the sciatic nerve, b) the sciatic branch to the quadratus femoris muscle and c) the superior gluteal nerves. Gerhardt et al showed that nociceptive fibers are predominantly present in the anterior and superolateral parts of the joint capsule, suggesting that the femoral and obturator nerves should be the most important nerves to target for hip analgesia.
The 3-in-1 block and FIB are currently used to provide hip analgesia. However, recent MRI imaging studies have shown that proximal local anesthetic spread was not consistent following a 3-in-1 block and did not consistently cover the obturator nerve. Similar findings were reported for the FIB.
A recent study on the innervation of the anterior hip revealed the relevant landmarks for the articular branches of the FN, AON and ON. This study found that high branches of femoral nerve, which were given off superior to the inguinal ligament, play a greater role in the anterior hip innervation than previously reported. These high articular branches of the FN and AON are consistently found between anterior inferior iliac spine (AIIS) and iliopubic eminence (IPE). With the help of ultrasound imaging, these landmarks can be identifiable and it is possible to target them directly in order to provide hip analgesia.
These recent data suggests that blocking these branches as they course deep to the iliopsoas muscle should result in superior hip joint analgesia compared to a FIB since the local anesthetic spread from a FIB is neither proximal nor deep enough to cover these articular branches consistently. Real-time ultrasound can help identify these proximal FN and AON branches using the anterior inferior iliac spine and the iliopubic eminence as landmarks.
The overall aim of this study is to determine in a prospective, randomized, double blind manner, the analgesic profile associated with two different regional anesthetic techniques: (1) FIB and (2) Femoral articular branches (FAB) block.
- Conditions
- Hip Fractures
- Being tested
- Fascia iliaca block, Femoral articular branches block(FAB)
- Keywords
- Fascia Iliaca Block, Femoral and Obturator Articular Branch Block
- 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 blockProcedure or surgery
FIB Placebo Block: 20mL of Normal Saline Active drug: 20mL of 0.25% Bupivacaine with epinephrine (1:400, 000)
FAB block Placebo Block: 20mL of Normal Saline Active Drug: 20mL of 0.25% Bupivacaine with epinephrine (1:400,000)
Femoral articular branches block(FAB)Procedure or surgery
FIB Placebo Block: 20mL of Normal Saline Active drug: 20mL of 0.25% Bupivacaine with epinephrine (1:400, 000)
FAB block Placebo Block: 20mL of Normal Saline Active Drug: 20mL of 0.25% Bupivacaine with epinephrine (1:400,000)
| Study group | Role | What they receive |
|---|---|---|
| Fascia iliaca block (FIB) | Active comparator | Group will receive Fascia iliaca block (FIB) with local anesthetic and femoral articular branch block (FAB) with normal saline (Placebo). Receives: Procedure: Fascia iliaca block |
| Femoral articular branches block(FAB) | Experimental | Group will receive Fascia iliaca block (FIB) with normal saline (Placebo) and Femoral AON articular branch block (FAB) with local anesthetic. Receives: Procedure: Femoral articular branches block(FAB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic pain score
Pain scores will be assessed with an 11-point verbal numeric rating scale (NSR) where 0 is "no pain" and 10 is "the worst pain imaginable" and dynamic pain will be assessed with 15 degrees straight leg raise.
The 15 degrees straight leg raise is a safe and standardized test to evaluate dynamic pain in hip fracture patients and has been used in a previous study.
Measured: 60 minutes after the block procedure
Secondary outcomes (4)
Rest pain score
Pain scores will be assessed with an 11-point verbal numeric rating scale (NSR) where 0 is "no pain" and 10 is "the worst pain imaginable" and dynamic pain will be assessed.
Measured: 30, 60, 120 and 180 minutes post-block
Dynamic pain score
Pain scores will be assessed with an 11-point verbal numeric rating scale (NSR) where 0 is "no pain" and 10 is "the worst pain imaginable" and dynamic pain will be assessed with 15 degrees straight leg raise.
Measured: 30, 120 and 180 minutes post-block
Cumulative systemic opioid consumption
oral morphine mg equivalents
Measured: 1 hour, 3 hours and 24 hours after the block procedure
Requirement "rescue" intravenous patient controlled analgesia (IV PCA)
If oral pain medication and block is not enough patient can get IV PCA.We will be recording requirement of IV PCA anytime in the first 24 hours after the block procedure.
Measured: within first 24 hours after the block procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start19 Feb 2019
- Primary completionSep 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double-blinded randomized prospective study involving patients with hip fracture who are undergoing surgical fixation.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip Peng, MD, Principal investigator, University Health Network-Toronto Western Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609645
- Sponsor's protocol ID
- 17-6067
- Status last verified
- Jul 2018
- First submitted
- 25 Jul 2018
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Analgesia for Hip Fracture: Femoral and Obturator Articular Branch Block vs. Fascia Iliaca Block. A Double-blind, Randomized- Controlled Trial.
- ClinicalTrials.gov ID
- NCT03609645
- Acronym / sponsor ID
- 17-6067
- Conditions
- Hip Fractures
- Keywords
- Fascia Iliaca Block, Femoral and Obturator Articular Branch Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 1 Aug 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 Fracture is a common orthopedic emergency in elderly people, which causes moderate to severe pain. Until now, different methods of pain treatment have been used, including pain-killer medication, which given in to the vein, and a nerve block.. A nerve block is the defined as injection of a freezing/numbing medication (local anesthetic) around the nerve area in order to stop pain.
Painkiller medications by themselves are not enough to stop pain, especially the pain that start with movement.
At the Toronto Western hospital, patients with hip fracture will generally receive a fascia iliac block (FIB) within 24 hours of hospital admission as a standard of care.
Fascia iliaca block is a nerve block done by injecting local anestheticat the level of the groin. This done to provide pain relief and is done either in the emergency room or in the inpatient area.
Studies have shown that nerves supplying other areas in the hip may be blocked to relive hip pain fracture.
Additional to this method, there is a newer type of nerve block, called the femoral articular branch block (FAB) that aim to block the nerves supplying the hip joint.
This new block has been described based on better understanding of the anatomy of the nerves that control hip pain. This block consists on an injection in the groin at a similar location as the Fascia iliaca block except that the needle has to go slightly deeper (by a few centimeters) to reach a better target.
Based on the current understanding on anatomy it is possible that this new technique may provide better pain control than a Fascia Iliaca Block.
The purpose of the study is to investigate the degree of pain relief achieved by the two different nerve block techniques: 1) Fascia iliaca block (FIB) and 2) Femoral and AON articular branches block (FAB).
Detailed description
The anterior hip joint is innervated by articular branches from the femoral nerve (FN), the obturator nerve (ON) and the accessory obturator nerve (AON). The posterior and inferior parts of the hip joint capsule are innervated by the sacral plexus via a) the sciatic nerve, b) the sciatic branch to the quadratus femoris muscle and c) the superior gluteal nerves. Gerhardt et al showed that nociceptive fibers are predominantly present in the anterior and superolateral parts of the joint capsule, suggesting that the femoral and obturator nerves should be the most important nerves to target for hip analgesia.
The 3-in-1 block and FIB are currently used to provide hip analgesia. However, recent MRI imaging studies have shown that proximal local anesthetic spread was not consistent following a 3-in-1 block and did not consistently cover the obturator nerve. Similar findings were reported for the FIB.
A recent study on the innervation of the anterior hip revealed the relevant landmarks for the articular branches of the FN, AON and ON. This study found that high branches of femoral nerve, which were given off superior to the inguinal ligament, play a greater role in the anterior hip innervation than previously reported. These high articular branches of the FN and AON are consistently found between anterior inferior iliac spine (AIIS) and iliopubic eminence (IPE). With the help of ultrasound imaging, these landmarks can be identifiable and it is possible to target them directly in order to provide hip analgesia.
These recent data suggests that blocking these branches as they course deep to the iliopsoas muscle should result in superior hip joint analgesia compared to a FIB since the local anesthetic spread from a FIB is neither proximal nor deep enough to cover these articular branches consistently. Real-time ultrasound can help identify these proximal FN and AON branches using the anterior inferior iliac spine and the iliopubic eminence as landmarks.
The overall aim of this study is to determine in a prospective, randomized, double blind manner, the analgesic profile associated with two different regional anesthetic techniques: (1) FIB and (2) Femoral articular branches (FAB) block.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a double-blinded randomized prospective study involving patients with hip fracture who are undergoing surgical fixation.
| Arm | Type | Receives |
|---|---|---|
| Fascia iliaca block (FIB) | Active comparator | Procedure: Fascia iliaca blockGroup will receive Fascia iliaca block (FIB) with local anesthetic and femoral articular branch block (FAB) with normal saline (Placebo). |
| Femoral articular branches block(FAB) | Experimental | Procedure: Femoral articular branches block(FAB)Group will receive Fascia iliaca block (FIB) with normal saline (Placebo) and Femoral AON articular branch block (FAB) with local anesthetic. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA Physical Status I-III
- 60 years old or older
- BMI 18-40
- Scheduled for hip fracture surgical fixation
Key exclusion criteria (5 listed)
- Bilateral hip fracture
- Lack of mental ability to provide informed consent
- Pre-existing neuropathic pain or sensory disorders of the surgical limb
- Contraindication to regional anesthesia (Intolerance to the study drugs, bleeding diathesis, coagulopathy, malignancy or infection at the site of the block)
- Chronic opioid use defined as >30 mg of daily oral morphine equivalents
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 blockFIB Placebo Block: 20mL of Normal Saline Active drug: 20mL of 0.25% Bupivacaine with epinephrine (1:400, 000) FAB block Placebo Block: 20mL of Normal Saline Active Drug: 20mL of 0.25% Bupivacaine with epinephrine (1:400,000) | Procedure or surgery | Fascia iliaca block (FIB) |
| Femoral articular branches block(FAB)FIB Placebo Block: 20mL of Normal Saline Active drug: 20mL of 0.25% Bupivacaine with epinephrine (1:400, 000) FAB block Placebo Block: 20mL of Normal Saline Active Drug: 20mL of 0.25% Bupivacaine with epinephrine (1:400,000) | Procedure or surgery | Femoral articular branches block(FAB) |
Primary outcome
Dynamic pain score
Time frame: 60 minutes after the block procedure
Pain scores will be assessed with an 11-point verbal numeric rating scale (NSR) where 0 is "no pain" and 10 is "the worst pain imaginable" and dynamic pain will be assessed with 15 degrees straight leg raise. The 15 degrees straight leg raise is a safe and standardized test to evaluate dynamic pain in hip fracture patients and has been used in a previous study.
4 secondary outcomes
Rest pain score
Time frame: 30, 60, 120 and 180 minutes post-block
Dynamic pain score
Time frame: 30, 120 and 180 minutes post-block
Cumulative systemic opioid consumption
Time frame: 1 hour, 3 hours and 24 hours after the block procedure
Requirement "rescue" intravenous patient controlled analgesia (IV PCA)
Time frame: within first 24 hours after the block procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
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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.
Philip Peng, MD principal investigator
University Health Network-Toronto Western Hospital
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 and Femoral articular branches block(FAB) in people with Hip Fractures, run by University Health Network, Toronto 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 4 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: status not confirmed, as of the sponsor's last update on 19 Mar 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rongyu Jin (4166035800 ext. 2016, rongyu.jin@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic pain score (time frame: 60 minutes after the block procedure). 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 19 Mar 2019; AzTrials last refreshed its copy on 6 Nov 2026.