Hip FracturesNCT04692857
US-guided FICB After Hip Fracture: the Effect of the Local Anesthetic Volume on the Quality of Preoperative Analgesia
A study testing supra inguinal fascia iliaca block in people with Hip Fractures, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
participants were randomly divided into three groups : group 30 , group 40 and group 50 . for all the three groups an ultrasound guided supra-inguinal fascia iliaca block had been performed. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- supra inguinal fascia iliaca block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTunisia
- Study dates
- 2 Jan 2020to 31 Aug 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patients aged above 65 years , american society of anesthesiologists physical status I to III , and with body mass index (BMI) of 35 kg/m² or less , undergoing hip fracture surgical repair .
Who cannot join
- inability or refusal to sign informed consent
- younger than 65 years
- BMI greater than 35 kg/m²
- presence of contraindications for regional nerve block or spinal anesthesia
- impaired cognition or dementia
- multiple fractures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Fascia Iliaca Compartment Block After Hip Fracture : the Effect of the Local Anesthetic Volume on the Quality of Preoperative Analgesia
participants were randomly divided into three groups : group 30 , group 40 and group 50 . for all the three groups an ultrasound guided supra-inguinal fascia iliaca block had been performed.
for group 30 ,a volume of 30 ml of 0,2 % ropivacaine had been injected for group 40 ,a volume of 40 ml of 0,2 % ropivacaine had been injected for group 50 ,a volume of 50 ml of 0,2 % ropivacaine had been injected
Read the detailed description
participants were randomly divided into three groups : group 30 , group 40 and group 50 . for all the three groups an ultrasound guided supra-inguinal fascia iliaca block had been performed.
A linear ultrasound probe was placed in the sagittal plane to obtain an image of the superior iliac spine.the fascia iliaca and sartorious,iliopsoas,and oblique internal muscles were identified by sliding the probe medially. After identifiying the "bow-tie sign"formed by the muscle fascias , an 50 mm needle was introduced 1-2 cm inferior to the inguinal ligament.using an in-plane approch, the fascia iliaca was penetrated and hydrodissected , separating the fascia iliaca from the iliac muscle. in this created space a total volume of 30 ml, 40ml or 50ml of 0.2% ropivacaine was injected , respectively to group 30 ,group 40 and group 50 .
pain score at rest and with a straight leg raise of the affected limb to 15 degrees were assessed before and 30 minutes after block performance.
- Conditions
- Hip Fractures
- Being tested
- supra inguinal fascia iliaca 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.
supra inguinal fascia iliaca blockProcedure or surgery
injection of 30,40 or 50 ml of 0.2 ropivacaine .
| Study group | Role | What they receive |
|---|---|---|
| group 30 | Experimental | participants received a supra inguinal fascia iliaca compartment block with 30 ml of 0.2% ropivacaine Receives: Procedure: supra inguinal fascia iliaca block |
| group 40 | Experimental | participants received a supra inguinal fascia iliaca compartment block with 40 ml of 0.2% ropivacaine Receives: Procedure: supra inguinal fascia iliaca block |
| group 50 | Experimental | participants received a supra inguinal fascia iliaca compartment block with 50 ml of 0.2% ropivacaine Receives: Procedure: supra inguinal fascia iliaca block |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in pain score on movement
change in verbal ranking scale(( vrs) with 0 indicating no pain and 10 indicating the worst imaginable pain)) during passive leg elevation to 15 degrees of the affected limb , before and 30 minutes after block placement
Measured: before and 30 minutes after block placement
Secondary outcomes (2)
change in pain score at rest
change in verbal ranking scale(( vrs) with 0 indicating no pain and 10 indicating the worst imaginable pain)) at rest, before and 30 minutes after block placement
Measured: before and 30 minutes after block placement
assessement of sensory block
sensory assessment of Femoral nerve , obturator nerve, and lateral femoral cutaneous nerve using the cold test . in the anterior , medial and lateral aspects of the thigh.
Measured: 30 minutes after block placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start2 Jan 2020
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
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.
- 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
- Outcomes assessor
- Enrolment
- 75 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, Study chair, university manar Tunis tunisia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692857
- Sponsor's protocol ID
- UTEM VOL FIBSI
- Status last verified
- Jan 2021
- First submitted
- 29 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- Ultrasound-guided Fascia Iliaca Compartment Block After Hip Fracture : the Effect of the Local Anesthetic Volume on the Quality of Preoperative Analgesia
- ClinicalTrials.gov ID
- NCT04692857
- Acronym / sponsor ID
- UTEM VOL FIBSI
- Conditions
- Hip Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 5 Jan 2021 (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.
participants were randomly divided into three groups : group 30 , group 40 and group 50 . for all the three groups an ultrasound guided supra-inguinal fascia iliaca block had been performed.
for group 30 ,a volume of 30 ml of 0,2 % ropivacaine had been injected for group 40 ,a volume of 40 ml of 0,2 % ropivacaine had been injected for group 50 ,a volume of 50 ml of 0,2 % ropivacaine had been injected
Detailed description
participants were randomly divided into three groups : group 30 , group 40 and group 50 . for all the three groups an ultrasound guided supra-inguinal fascia iliaca block had been performed.
A linear ultrasound probe was placed in the sagittal plane to obtain an image of the superior iliac spine.the fascia iliaca and sartorious,iliopsoas,and oblique internal muscles were identified by sliding the probe medially. After identifiying the "bow-tie sign"formed by the muscle fascias , an 50 mm needle was introduced 1-2 cm inferior to the inguinal ligament.using an in-plane approch, the fascia iliaca was penetrated and hydrodissected , separating the fascia iliaca from the iliac muscle. in this created space a total volume of 30 ml, 40ml or 50ml of 0.2% ropivacaine was injected , respectively to group 30 ,group 40 and group 50 .
pain score at rest and with a straight leg raise of the affected limb to 15 degrees were assessed before and 30 minutes after block performance.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 30 | Experimental | Procedure: supra inguinal fascia iliaca blockparticipants received a supra inguinal fascia iliaca compartment block with 30 ml of 0.2% ropivacaine |
| group 40 | Experimental | Procedure: supra inguinal fascia iliaca blockparticipants received a supra inguinal fascia iliaca compartment block with 40 ml of 0.2% ropivacaine |
| group 50 | Experimental | Procedure: supra inguinal fascia iliaca blockparticipants received a supra inguinal fascia iliaca compartment block with 50 ml of 0.2% ropivacaine |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- patients aged above 65 years , american society of anesthesiologists physical status I to III , and with body mass index (BMI) of 35 kg/m² or less , undergoing hip fracture surgical repair .
Key exclusion criteria (6 listed)
- inability or refusal to sign informed consent
- younger than 65 years
- BMI greater than 35 kg/m²
- presence of contraindications for regional nerve block or spinal anesthesia
- impaired cognition or 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 |
|---|---|---|
| supra inguinal fascia iliaca blockinjection of 30,40 or 50 ml of 0.2 ropivacaine . | Procedure or surgery | group 30, group 40, group 50 |
Primary outcome
change in pain score on movement
Time frame: before and 30 minutes after block placement
change in verbal ranking scale(( vrs) with 0 indicating no pain and 10 indicating the worst imaginable pain)) during passive leg elevation to 15 degrees of the affected limb , before and 30 minutes after block placement
2 secondary outcomes
change in pain score at rest
Time frame: before and 30 minutes after block placement
assessement of sensory block
Time frame: 30 minutes after block placement
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.
- Individual participant dataSharing planned: No
Related trials for Hip Fractures
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 study chair
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 supra inguinal fascia iliaca block in people with Hip Fractures, 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 6 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?
change in pain score on movement (time frame: before and 30 minutes after block placement). 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.