Hip FractureNCT04692428
Comparison of the Ultrasound Supra-inguinal Fascia Iliaca Block vs Femoral Nerve Block
A study testing Locoregional analgesia in people with Hip Fracture, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
Patients were randomly assigned to tow groups: infrainguinal ultrasound guided iliaca fascia block (FIBSI) and femoral nerve block (FNB) for FIBSI, the probe is placed transversely between anterior superior iliac spine (ASIS) and the pubic spine. The transducer is translated laterally to identify the Sartorius muscle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fracture
- What is being tested?
- Locoregional analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTunisia
- Study dates
- 20 Apr 2019to 20 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA (American Society of Anesthesiologists) class I, II, and III patients scheduled for emergency surgery with the diagnosis of proximal femur fracture
Who cannot join
- hemorrhagic diathesis,
- peripheral neuropathies,
- allergy to amide local anaesthetics,
- mental disorders,
- those on analgesics within 8 hour prior to performing nerve block
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fracture of the Upper Femoral Extremity in the Elderly Patients: Comparison of the Supra-inguinal Fascia Iliaca Block VS Femoral Nerve Block Ultrasound Guided in the Positioning and Post-operative Analgesia for Spinal Anesthesia
Patients were randomly assigned to tow groups: infrainguinal ultrasound guided iliaca fascia block (FIBSI) and femoral nerve block (FNB) for FIBSI, the probe is placed transversely between anterior superior iliac spine (ASIS) and the pubic spine. The transducer is translated laterally to identify the Sartorius muscle. Cephalic inclination of the probe. The medial end of the transducer faces towards the umbilicus, which is the final position. The 100mm neurostimulation needle is advanced in the In Plan approach to pass through the iliac fascia. Once the correct position is confirmed, 30 ml of 1% Ropivacaine is gradually injected between the iliac fascia and the iliac muscle.
For FNB, the probe was placed under the inguinal ligament. The femoral vessels and the nerve section are visualized; The 100mm neurostimulation needle is advanced in the In Plan approach and 30ml of 1% Ropivacaine has been injected along the nerve sheath
Read the detailed description
Patients were randomly assigned to tow groups: infrainguinal ultrasound guided iliaca fascia block (FIBSI) and femoral nerve block (FNB) for FIBSI,the probe is placed transversely between the EIAS and the pubic spine,The transducer is translated laterally to identify the sartorius muscle. Cephalic inclination of the probe: The iliac muscle is located at the medial border in the shadow of the superior anterior iliac spine.The medial end of the transducer faces towards the umbilicus, which is the final position.
The anatomy identified, from superficial to deep, consisting of subcutaneous fat, internal oblique muscle, transverse abdominal muscle, iliaca fascia covering the iliac muscle. The 100mm neurostimulation needle is advanced in In Plan approach to cross the iliaca fascia. With the tip of the needle just below the iliaca fascia, 2 ml of local anesthetic was injected to confirm the location of the tip. Once the correct position is confirmed, 30 ml of 1% Ropivacaine is gradually injected between the iliac fascia and the iliac muscle.
for FNB,The probe was placed under the inguinal ligament. Femoral vessels and sectional nerve are visualized. The nerve was located, an 100mm neurostimulation needle is advanced in In Plan approach, and 30 ml of 1% Ropivacaine was injected along the nerve sheath.
- Conditions
- Hip Fracture
- Being tested
- Locoregional analgesia
- Keywords
- analgesia, hip fracture, nerve block
- Medical subject headings
- Hip Fractures, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locoregional analgesiaProcedure or surgery
the supra-inguinal fascia iliaca block versus the femoral nerve block
| Study group | Role | What they receive |
|---|---|---|
| FIBSI group | Experimental | ultrasound supra inguinal Fascia iliaca block Receives: Procedure: Locoregional analgesia |
| FNB group | Experimental | ultrasound femoral nerve block Receives: Procedure: Locoregional analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positioning pain before performing spinal anesthesia
Pain in positioning was assessed by measuring the simple verbal scale (0= no pain- 4= worst pain possible) after 20 minutes for realization block
Measured: 20 minutes after realization of blocks
Secondary outcomes (4)
Postoperative pain
Postoperative pain was assessed by the Simple Verbal Scale (SVS) at the third, sixth, twelfth and twenty-four hours postoperatively
Measured: at the third, sixth, twelfth and twenty-four hours postoperatively
quality of patient placement in the sitting position
The quality of patient positioning was subjectively rated as unsatisfactory, good or optimal depending on the ease of positioning for spinal anesthesia
Measured: after 20 minutes of realization of block
The level of sensory block at 20 minutes after realization of block
The quality of the sensory block was evaluated by the PinPrick Test in the external, internal and anterior part of the thigh in comparison with the same stimulation at the level of the contralateral limb.
using a sterile needle at 20 minutes after realization of block on the territory of femoral, obturator and lateral cutaneous nerve of the thigh
Measured: before and 20 minutes after realization of blocks
Patient satisfaction
Patient satisfaction was evaluated after completion of spinal anesthesia by using a two-point score: 1= good, if necessary, I'll repeat it and 2= bad, I will never repeat it again.
Measured: five minutes after the end of the realization of spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start20 Apr 2019
- Primary completion20 Dec 2019
- Study completion20 Dec 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mechaal Benali, University Tunis El Manar
- Investigators
- mechaal benali, PROFESSOR, Principal investigator, university manar Tunis tunisia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692428
- Sponsor's protocol ID
- UTEM FIBSI
- Status last verified
- Jan 2021
- First submitted
- 25 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fracture of the Upper Femoral Extremity in the Elderly Patients: Comparison of the Supra-inguinal Fascia Iliaca Block VS Femoral Nerve Block Ultrasound Guided in the Positioning and Post-operative Analgesia for Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT04692428
- Acronym / sponsor ID
- UTEM FIBSI
- Conditions
- Hip Fracture
- Keywords
- analgesia, hip fracture, nerve block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 20 Apr 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 31 Dec 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.
Patients were randomly assigned to tow groups: infrainguinal ultrasound guided iliaca fascia block (FIBSI) and femoral nerve block (FNB) for FIBSI, the probe is placed transversely between anterior superior iliac spine (ASIS) and the pubic spine. The transducer is translated laterally to identify the Sartorius muscle. Cephalic inclination of the probe. The medial end of the transducer faces towards the umbilicus, which is the final position. The 100mm neurostimulation needle is advanced in the In Plan approach to pass through the iliac fascia. Once the correct position is confirmed, 30 ml of 1% Ropivacaine is gradually injected between the iliac fascia and the iliac muscle.
For FNB, the probe was placed under the inguinal ligament. The femoral vessels and the nerve section are visualized; The 100mm neurostimulation needle is advanced in the In Plan approach and 30ml of 1% Ropivacaine has been injected along the nerve sheath
Detailed description
Patients were randomly assigned to tow groups: infrainguinal ultrasound guided iliaca fascia block (FIBSI) and femoral nerve block (FNB) for FIBSI,the probe is placed transversely between the EIAS and the pubic spine,The transducer is translated laterally to identify the sartorius muscle. Cephalic inclination of the probe: The iliac muscle is located at the medial border in the shadow of the superior anterior iliac spine.The medial end of the transducer faces towards the umbilicus, which is the final position.
The anatomy identified, from superficial to deep, consisting of subcutaneous fat, internal oblique muscle, transverse abdominal muscle, iliaca fascia covering the iliac muscle. The 100mm neurostimulation needle is advanced in In Plan approach to cross the iliaca fascia. With the tip of the needle just below the iliaca fascia, 2 ml of local anesthetic was injected to confirm the location of the tip. Once the correct position is confirmed, 30 ml of 1% Ropivacaine is gradually injected between the iliac fascia and the iliac muscle.
for FNB,The probe was placed under the inguinal ligament. Femoral vessels and sectional nerve are visualized. The nerve was located, an 100mm neurostimulation needle is advanced in In Plan approach, and 30 ml of 1% Ropivacaine was injected along the nerve sheath.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FIBSI group | Experimental | Procedure: Locoregional analgesiaultrasound supra inguinal Fascia iliaca block |
| FNB group | Experimental | Procedure: Locoregional analgesiaultrasound femoral nerve block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA (American Society of Anesthesiologists) class I, II, and III patients scheduled for emergency surgery with the diagnosis of proximal femur fracture
Key exclusion criteria (5 listed)
- hemorrhagic diathesis,
- peripheral neuropathies,
- allergy to amide local anaesthetics,
- mental disorders,
- those on analgesics within 8 hour prior to performing nerve block
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 |
|---|---|---|
| Locoregional analgesiathe supra-inguinal fascia iliaca block versus the femoral nerve block | Procedure or surgery | FIBSI group, FNB group |
Primary outcome
Positioning pain before performing spinal anesthesia
Time frame: 20 minutes after realization of blocks
Pain in positioning was assessed by measuring the simple verbal scale (0= no pain- 4= worst pain possible) after 20 minutes for realization block
4 secondary outcomes
Postoperative pain
Time frame: at the third, sixth, twelfth and twenty-four hours postoperatively
quality of patient placement in the sitting position
Time frame: after 20 minutes of realization of block
The level of sensory block at 20 minutes after realization of block
Time frame: before and 20 minutes after realization of blocks
Patient satisfaction
Time frame: five minutes after the end of the realization of spinal anesthesia
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 5 Jan 2021.
Related trials for Hip Fracture
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures
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.
mechaal benali, PROFESSOR principal investigator
university manar Tunis tunisia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Locoregional analgesia in people with Hip Fracture, run by University Tunis El Manar at 1 site in Tunisia.
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 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 5 Jan 2021. 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 Tunisia. 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?
Positioning pain before performing spinal anesthesia (time frame: 20 minutes after realization of blocks). 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 5 Jan 2021.