Proximal Femur FractureNCT04309539
Which Analgesia is Better for Proximal Femoral Fractures?
A study testing Fascia iliaca block and combined LFCN block with PENG block in people with Proximal Femur Fracture, run by Mansoura University at 1 site in Egypt.
Trial summary
This patient population is typically elderly and frail. They are at risk of adverse effects secondary to inadequate pain management such as prolonged admissions and poor functional outcomes. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Proximal Femur Fracture
- What is being tested?
- Fascia iliaca block and combined LFCN block with PENG block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Sep 2020to Mar 2022
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I, II and III.
Who cannot join
- Patient refusal.
- Neuromuscular diseases
- Hematological diseases
- Bleeding abnormality
- Coagulation abnormality.
- Psychiatric diseases.
Show all 11Show fewer
- Local skin infection at the site of the block.
- Local skin sepsis at the site of the block
- Known intolerance to the study drugs.
- Body Mass Index > 40 Kg/m2.
- Multiple trauma patients.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University, emergency hospital
Al Mansurah, DK, 050
Mona A Hasheesh, MD, 00201027034020, drmonahasheesh@hotmail.com
Eyad A Ramzy, MD, 00201005774079, eiadramzy@yahoo.com
About this study
Official title: - Efficacy of Combined Lateral Femoral Cutaneous Nerve Block With Pericapsular Nerve Group Block Versus Fascia Iliaca Block in Proximal Femoral Fractures
This patient population is typically elderly and frail. They are at risk of adverse effects secondary to inadequate pain management such as prolonged admissions and poor functional outcomes.
Regional analgesia is preferred due to their opioid-sparing effects and reduction in related adverse effects but The analgesia from these blocks is only moderate and literature suggests that the obturator nerve (ON) is not covered.
Read the detailed description
The aim of this study is to compare the effect of combined lateral femoral cutaneous nerve block with pericapsular nerve group block versus fascia iliaca block for proximal femur surgery.
Fascia iliaca compartment block is a simple technique to manage pain before positioning for spinal anesthesia performance and it constitutes a practical choice for perioperative pain control.
A recent anatomical study confirmed the innervation of the anterior hip by these 3 main nerves, but also found that the AON and FN play a greater role in the anterior hip innervation than previously reported The high articular branches from FN and AON are consistently found between the anterior inferior iliac spine (AIIS) and the iliopubic eminence (IPE), whereas the ON is located close to the inferomedial acetabulum.
The ultrasound-guided technique for blockade of these articular branches to the hip, the PENG (Pericapsular Nerve Group) block reported significantly reduced pain scores compared with baseline. Roy et al 2019 recommended the use of PENG block together with LFCN block as adjunctive to cover the lateral surgical incision.
- Conditions
- Proximal Femur Fracture
- Being tested
- Fascia iliaca block, combined LFCN block with PENG block
- Medical subject headings
- Proximal Femoral 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
A linear probe will be placed in the sagittal plane to the inguinal ligament to obtain an image of "bow-tie sign" formed by the muscle fascias, a spinal needle will be inserted 1 cm cephalad Using an in-plane approach, the fascia iliaca is penetrated, 30 mL of bupivacaine 0.25% before spinal anesthesia.
combined LFCN block with PENG blockProcedure or surgery
With the patient supine, the linear probe is placed parallel to the inguinal ligament. LFCN appear as a hypoechoic oval structure between the tensor fascia lata and Sartorius muscles. The needle is inserted in plane. 5 mL of LA is injected. The PENG block will be performed in the supine position. A curvilinear probe will be placed transversely over the anterior inferior iliac spine and then rotated counterclockwise 45 degrees. the ilio pubic eminence, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be observed. A spinal needle will be inserted in plane to the plane between the psoas tendon and the pubic ramus. 25 mL of bupivacaine 0.25% will be injected
| Study group | Role | What they receive |
|---|---|---|
| Fascia iliaca block | Active comparator | Patients will receive Fascia iliaca block Receives: Procedure: Fascia iliaca block |
| combined LFCN block with PENG block | Active comparator | Patients will receive a combined lateral femoral cutaneous nerve block with pericapsular nerve group block Receives: Procedure: combined LFCN block with PENG block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of performance of Spinal Anesthesia
Is defined as the time measured from the start of positioning to the completion of the intrathecal bupivacaine injection
Measured: just before surgery.
Secondary outcomes (18)
Pain measurement at rest
10-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain
Measured: immediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery.
Pain measurement on movement
(attempted hip flexion to 15 degrees).: 10-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain
Measured: immediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery.
Pain measurement during positioning for spinal anesthesia
visual analog scale (0-10, 0: no pain, 10: worst pain imaginable) during changing position from supine to sitting one
Measured: Just before surgery
The severity of postoperative pain at rest
10-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain
Measured: immediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery.
The severity of postoperative pain on movement
(attempted hip flexion to 15 degrees): 10-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain
Measured: immediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery.
Time to onset of Sensory blockade
cold perception loss in the lateral, anterior and medial part of the thigh (corresponding to lateral femoral cutaneous (LFC), femoral (F) and obturator (O)nerve sensory distributions, respectively)
Measured: evaluated 15 and 30 min after block administration
Time to onset of motor block
defined as assessment of quadriceps femoris muscle strength by straight leg raise test to 15 degree and classified as follow: +ve =normal power, -ve =motor weakness
Measured: evaluated 15 and 30 min after block administration
Duration of sensory block
blockade is defined as the interval between end of injection and complete end of sensory block (score=2)
Measured: postoperative 24 hours
Duration of motor block
blockade is defined as the interval between end of injection and complete end of injection and complete recovery of normal motor function (score=0),
Measured: postoperative 24 hours
Anesthesiology satisfaction for patient positioning
evaluated as 0=unsatisfactory, 1=satisfactory, 2=good or 3=optimal
Measured: just before surgery
heart rate
Changes in heart rate
Measured: pre-block, 15, 30 min after block, immediately after spinal anesthesia, 5min, 15min then every 30 min till end of surgery
Mean arterial blood pressure
Changes in Mean arterial blood pressure
Measured: pre-block, 15, 30 min after block, immediately after spinal anesthesia, 5min, 15min then every 30 min till end of surgery
Peripheral oxygen saturation
Changes in peripheral oxygen saturation as measured with pulse oximetry
Measured: pre-block, 15, 30 min after block, immediately after spinal anesthesia, 5min, 15min then every 30 min till end of surgery
Time for first analgesic request
defined as the time period from end of injection to the first time patient requests analgesia postoperatively
Measured: Within 24 hours after surgery
Total analgesics received
cumulative consumption of opioids during the first postoperative day
Measured: for 24 hrs after surgery
Pruritis
number of patients with pruritis
Measured: Within 24 hours after surgery
nausea
number of patients with nausea
Measured: Within 24 hours after surgery
vomiting
number of patients with vomiting
Measured: Within 24 hours 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 Mar 2020
- Study start21 Sep 2020
- Primary completionJun 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Femur FractureStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mona A Hasheesh, MD, Study chair, Professor of Anesthesia and Surgical Intensive care,,PEiad A Ramzy, MD, Study director, Associate Professor of Anesthesia and Surgical Intensive care,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309539
- Sponsor's protocol ID
- MFM-IRB, MD.20.02.280
- Status last verified
- Sep 2020
- First submitted
- 12 Mar 2020
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes, Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- - Efficacy of Combined Lateral Femoral Cutaneous Nerve Block With Pericapsular Nerve Group Block Versus Fascia Iliaca Block in Proximal Femoral Fractures
- ClinicalTrials.gov ID
- NCT04309539
- Acronym / sponsor ID
- MFM-IRB, MD.20.02.280
- Conditions
- Proximal Femur Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 16 Mar 2020 (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.
This patient population is typically elderly and frail. They are at risk of adverse effects secondary to inadequate pain management such as prolonged admissions and poor functional outcomes.
Regional analgesia is preferred due to their opioid-sparing effects and reduction in related adverse effects but The analgesia from these blocks is only moderate and literature suggests that the obturator nerve (ON) is not covered.
Detailed description
The aim of this study is to compare the effect of combined lateral femoral cutaneous nerve block with pericapsular nerve group block versus fascia iliaca block for proximal femur surgery.
Fascia iliaca compartment block is a simple technique to manage pain before positioning for spinal anesthesia performance and it constitutes a practical choice for perioperative pain control.
A recent anatomical study confirmed the innervation of the anterior hip by these 3 main nerves, but also found that the AON and FN play a greater role in the anterior hip innervation than previously reported The high articular branches from FN and AON are consistently found between the anterior inferior iliac spine (AIIS) and the iliopubic eminence (IPE), whereas the ON is located close to the inferomedial acetabulum.
The ultrasound-guided technique for blockade of these articular branches to the hip, the PENG (Pericapsular Nerve Group) block reported significantly reduced pain scores compared with baseline. Roy et al 2019 recommended the use of PENG block together with LFCN block as adjunctive to cover the lateral surgical incision.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fascia iliaca block | Active comparator | Procedure: Fascia iliaca blockPatients will receive Fascia iliaca block |
| combined LFCN block with PENG block | Active comparator | Procedure: combined LFCN block with PENG blockPatients will receive a combined lateral femoral cutaneous nerve block with pericapsular nerve group block |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status I, II and III.
Key exclusion criteria (11 listed)
- Patient refusal.
- Neuromuscular diseases
- Hematological diseases
- Bleeding abnormality
- Coagulation abnormality.
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 blockA linear probe will be placed in the sagittal plane to the inguinal ligament to obtain an image of "bow-tie sign" formed by the muscle fascias, a spinal needle will be inserted 1 cm cephalad Using an in-plane approach, the fascia iliaca is penetrated, 30 mL of bupivacaine 0.25% before spinal anesthesia. | Procedure or surgery | Fascia iliaca block |
| combined LFCN block with PENG blockWith the patient supine, the linear probe is placed parallel to the inguinal ligament. LFCN appear as a hypoechoic oval structure between the tensor fascia lata and Sartorius muscles. The needle is inserted in plane. 5 mL of LA is injected. The PENG block will be performed in the supine position. A curvilinear probe will be placed transversely over the anterior inferior iliac spine and then rotated counterclockwise 45 degrees. the ilio pubic eminence, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be observed. A spinal needle will be inserted in plane to the plane between the psoas tendon and the pubic ramus. 25 mL of bupivacaine 0.25% will be injected | Procedure or surgery | combined LFCN block with PENG block |
Primary outcome
Time of performance of Spinal Anesthesia
Time frame: just before surgery.
Is defined as the time measured from the start of positioning to the completion of the intrathecal bupivacaine injection
18 secondary outcomes
Pain measurement at rest
Time frame: immediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery.
Pain measurement on movement
Time frame: immediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery.
Pain measurement during positioning for spinal anesthesia
Time frame: Just before surgery
The severity of postoperative pain at rest
Time frame: immediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery.
The severity of postoperative pain on movement
Time frame: immediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery.
Time to onset of Sensory blockade
Time frame: evaluated 15 and 30 min after block administration
Time to onset of motor block
Time frame: evaluated 15 and 30 min after block administration
Duration of sensory block
Time frame: postoperative 24 hours
Duration of motor block
Time frame: postoperative 24 hours
Anesthesiology satisfaction for patient positioning
Time frame: just before surgery
heart rate
Time frame: pre-block, 15, 30 min after block, immediately after spinal anesthesia, 5min, 15min then every 30 min till end of surgery
Mean arterial blood pressure
Time frame: pre-block, 15, 30 min after block, immediately after spinal anesthesia, 5min, 15min then every 30 min till end of surgery
Peripheral oxygen saturation
Time frame: pre-block, 15, 30 min after block, immediately after spinal anesthesia, 5min, 15min then every 30 min till end of surgery
Time for first analgesic request
Time frame: Within 24 hours after surgery
Total analgesics received
Time frame: for 24 hrs after surgery
Pruritis
Time frame: Within 24 hours after surgery
nausea
Time frame: Within 24 hours after surgery
vomiting
Time frame: Within 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Individual participant dataSharing planned: Yes. Yes, Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)
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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.
Mona A Hasheesh, MD study chair
Professor of Anesthesia and Surgical Intensive care,,P
Eiad A Ramzy, MD study director
Associate Professor of Anesthesia and Surgical Intensive care,
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 combined LFCN block with PENG block in people with Proximal Femur Fracture, run by Mansoura University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 23 Sep 2020. 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 Egypt. 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 Mona A Hasheesh, MD (00201027034020, drmonahasheesh@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of performance of Spinal Anesthesia (time frame: just before surgery.). 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 23 Sep 2020.