Hip FractureNCT04285333
Ultrasound Percapsular Nerve Group Block VS Fascia Iliaca Block for Hip Fracture
A study testing fascia iliaca block and percapsular nerve group block in people with Hip Fracture and Analgesia, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
Spinal anesthesia (SA) is a widely accepted anesthetic technique for hip fracture repair among elderly. Positioning for SA can be extremely painful. Effective management of pain is important for these patients comfort. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fracture, Analgesia, Acute Pain
- What is being tested?
- fascia iliaca block and percapsular nerve group block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTunisia
- Study dates
- 17 Mar 2020to 31 May 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- - Patients aged ≥ 65 years old and undergoing hip fracture surgical repair under continuous spinal anesthesia (CSA).
- Patients for whom pain was felt when raising the affected limb to 15 degrees (VERBAL PAIN SCALE =2)
Who cannot join
- - ASA physical status ≥ 4.
- Impaired cognition or Dementia.
- Multiple fractures.
- Contraindication to regional anesthesia.
- Patient's disapproval.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Techniques Before Spinal Anesthesia for Hip Fracture Repair: Ultrasound Percapsular Nerve Group Block VS Fascia Iliaca Block
Spinal anesthesia (SA) is a widely accepted anesthetic technique for hip fracture repair among elderly. Positioning for SA can be extremely painful. Effective management of pain is important for these patients comfort.
Fascia Iliaca block (FIB) and Femoral nerve blocks are commonly used for analgesia in hip fracture patients. However, they often provide a modest reduction in pain.
Read more
The Percapsular Nerve Group block (PENG Block) has the advantage that it covers the accessory obturator nerve.
Aim of the study: compare FIB with PENG prior to positioning hip fracture patients for standardized SA.
In a prospective randomized double blind we included 80 patients aged more than 65 years old, for whom pain was felt when raising the affected limb to 15 degrees. Patients were assigned to receive either ultrasound guided Fascia Iliaca block or Percapsular Nerve Group block using 20 mL Lidocaine 1.5% in both groups. We compared pain on positioning for spinal anesthesia using Verbal Rating Scale (VRS 0 = no pain , VRS 1 = mild pain, t 2= severe pain) for both groups. We also recorded different times to perfom block.
Read the detailed description
The purpose of the study was to compare analgesis effect of Percapsula nerve group block to fascia iliaca block prior to positioning hip fracture patients for standardized SA. We included 80 patients reporting pain with Verbal Rating Scale at 2 when raising the affected limb to 15 degrees. All patients admitted to induction room, were given standard monitoring and we randomized to receive either: ultrasound fascia iliaca block using linear high frequency ultrasound probe (10-15MHz) placed in a transverse direction over the anterior thigh below the inguinal ligament. A 50 mm needle was advanced until the tips placed underneath the fascia iliaca and 20 mL 1.5% Lidocaine was injected or ultrasound Percapsula nerve group block A curvilinear using low-frequency ultrasound probe (2-5MHz) that was initially placed in a transverse plane over the anterior inferior iliac spine and then aligned with the pubic ramus by rotating the probe counter clockwise approximately 45 degrees. In this view, the iliopubic eminence , the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed and than a 100 mm needle was advanced to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly and 20 mL 1.5% Lidocaine.We compared pain on positioning for spinal anesthesia and also different time to realise both blocks.
- Conditions
- Hip Fracture, Analgesia, Acute Pain
- Being tested
- fascia iliaca block, percapsular nerve group block
- Keywords
- hip fracture, nerve block, spinal anesthesia, analgesia
- Medical subject headings
- Hip Fractures, Agnosia, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fascia iliaca blockProcedure or surgery
Also called BIF for hip fracture
ultrasound guided block with 20 mL lidocaine 1.5%
percapsular nerve group blockProcedure or surgery
Also called PENG block for hip fracture
ultrasound guided block with 20 mL lidocaine 1.5%
| Study group | Role | What they receive |
|---|---|---|
| fascial iliaca | Active comparator | : A linear high frequency ultrasound probe (10-15MHz) was placed in a transverse direction over the anterior thigh below the inguinal ligament. We identified the femoral artery and the iliacus muscle lateral to it, covered by the fascia iliaca. The needle was inserted in plane and a 22 gauge, 50 mm needle was advanced until the tips placed underneath the fascia iliaca. Following negative aspiration, the local anesthetic solution was injected in 5mL increments while observing for adequate fluid spread in this plane for a total volume of 20 mL of 1.5% Lidocaine Receives: Procedure: fascia iliaca block |
| Percapsular nerve group block | Experimental | A curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the anterior inferior iliac spine (AIIS) and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the iliopubic eminence (IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 100-mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anesthetic solution was injected in 5 mL increments while observing for adequate fluid spread in this plane for a total volume of 20 mL of 1.5% Lidocaine. Receives: Procedure: percapsular nerve group block |
What is being measured
The primary outcome is the main question the study is designed to answer.
positioning pain
Verbal Rating Scale (VRS) [0=no pain ; 4=worst pain]
Measured: up to 30 minutes
Secondary outcomes (9)
Positioning Rating
verbal rating scale (VRS) [0=no pain ; 4=worst pain]
Measured: up to 40 minutes
Imaging time
For the PENG block:the femoral artery, the anterior inferior iliac spine, the iliopubic eminence and the psoas tendon.
For the FIB: the femoral artery, the iliacus muscle, the fascia iliaca and the fascia lata.
Measured: up to 10 minutes
Puncture time
the time that stretches from the introduction of the needle until the end of the injection of local anesthetic
Measured: up to 10 minutes
Performance time
the imaging time + time to puncture.
Measured: up to 10 minutes
Number of punctures
the number of redirection of the needle after removing 2 cm.
Measured: up to 10 minutes
pain 5 after block
verbal rating scale (VRS) [0=no pain ; 4=worst pain]
Measured: up to 5 minutes
pain 10 after block
verbal rating scale (VRS) [0=no pain ; 4=worst pain]
Measured: up to 10 minutes
pain 15 after block
verbal rating scale (VRS) [0=no pain ; 4=worst pain]
Measured: up to 15 minutes
pain 20 after block
verbal rating scale (VRS) [0=no pain ; 4=worst pain]
Measured: up to 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start17 Mar 2020
- Primary completion30 Apr 2020
- Study completion31 May 2022
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomised single blinded study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Kassab d'Orthopédie
- Responsible party
- Principal investigator, Olfa kaabachi, MD, University Tunis El Manar
- Investigators
- khaireddine Raddaoui, MD, Principal investigator, Tunis El Manar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285333
- Sponsor's protocol ID
- CE-IMKO 102/2019
- Status last verified
- Feb 2024
- First submitted
- 9 Feb 2020
- Last updated
- 13 Feb 2024
- 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 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Techniques Before Spinal Anesthesia for Hip Fracture Repair: Ultrasound Percapsular Nerve Group Block VS Fascia Iliaca Block
- ClinicalTrials.gov ID
- NCT04285333
- Acronym / sponsor ID
- CE-IMKO 102/2019
- Conditions
- Hip Fracture, Analgesia, Acute Pain
- Keywords
- hip fracture, nerve block, spinal anesthesia, analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Collaborators
- Institut Kassab d'Orthopédie
- Study start
- 17 Mar 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 26 Feb 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.
Spinal anesthesia (SA) is a widely accepted anesthetic technique for hip fracture repair among elderly. Positioning for SA can be extremely painful. Effective management of pain is important for these patients comfort.
Fascia Iliaca block (FIB) and Femoral nerve blocks are commonly used for analgesia in hip fracture patients. However, they often provide a modest reduction in pain.
The Percapsular Nerve Group block (PENG Block) has the advantage that it covers the accessory obturator nerve.
Aim of the study: compare FIB with PENG prior to positioning hip fracture patients for standardized SA.
In a prospective randomized double blind we included 80 patients aged more than 65 years old, for whom pain was felt when raising the affected limb to 15 degrees. Patients were assigned to receive either ultrasound guided Fascia Iliaca block or Percapsular Nerve Group block using 20 mL Lidocaine 1.5% in both groups. We compared pain on positioning for spinal anesthesia using Verbal Rating Scale (VRS 0 = no pain , VRS 1 = mild pain, t 2= severe pain) for both groups. We also recorded different times to perfom block.
Detailed description
The purpose of the study was to compare analgesis effect of Percapsula nerve group block to fascia iliaca block prior to positioning hip fracture patients for standardized SA. We included 80 patients reporting pain with Verbal Rating Scale at 2 when raising the affected limb to 15 degrees. All patients admitted to induction room, were given standard monitoring and we randomized to receive either: ultrasound fascia iliaca block using linear high frequency ultrasound probe (10-15MHz) placed in a transverse direction over the anterior thigh below the inguinal ligament. A 50 mm needle was advanced until the tips placed underneath the fascia iliaca and 20 mL 1.5% Lidocaine was injected or ultrasound Percapsula nerve group block A curvilinear using low-frequency ultrasound probe (2-5MHz) that was initially placed in a transverse plane over the anterior inferior iliac spine and then aligned with the pubic ramus by rotating the probe counter clockwise approximately 45 degrees. In this view, the iliopubic eminence , the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed and than a 100 mm needle was advanced to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly and 20 mL 1.5% Lidocaine.We compared pain on positioning for spinal anesthesia and also different time to realise both blocks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Prospective randomised single blinded study
| Arm | Type | Receives |
|---|---|---|
| fascial iliaca | Active comparator | Procedure: fascia iliaca block: A linear high frequency ultrasound probe (10-15MHz) was placed in a transverse direction over the anterior thigh below the inguinal ligament. We identified the femoral artery and the iliacus muscle lateral to it, covered by the fascia iliaca. The needle was inserted in plane and a 22 gauge, 50 mm needle was advanced until the tips placed underneath the fascia iliaca. Following negative aspiration, the local anesthetic solution was injected in 5mL increments while observing for adequate fluid spread in this plane for a total volume of 20 mL of 1.5% Lidocaine |
| Percapsular nerve group block | Experimental | Procedure: percapsular nerve group blockA curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the anterior inferior iliac spine (AIIS) and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the iliopubic eminence (IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 100-mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anesthetic solution was injected in 5 mL increments while observing for adequate fluid spread in this plane for a total volume of 20 mL of 1.5% Lidocaine. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- - Patients aged ≥ 65 years old and undergoing hip fracture surgical repair under continuous spinal anesthesia (CSA).
- Patients for whom pain was felt when raising the affected limb to 15 degrees (VERBAL PAIN SCALE =2)
Key exclusion criteria (5 listed)
- - ASA physical status ≥ 4.
- Impaired cognition or Dementia.
- Multiple fractures.
- Contraindication to regional anesthesia.
- Patient's disapproval.
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 blockAlso: BIF for hip fractureultrasound guided block with 20 mL lidocaine 1.5% | Procedure or surgery | fascial iliaca |
| percapsular nerve group blockAlso: PENG block for hip fractureultrasound guided block with 20 mL lidocaine 1.5% | Procedure or surgery | Percapsular nerve group block |
Primary outcome
positioning pain
Time frame: up to 30 minutes
Verbal Rating Scale (VRS) [0=no pain ; 4=worst pain]
9 secondary outcomes
Positioning Rating
Time frame: up to 40 minutes
Imaging time
Time frame: up to 10 minutes
Puncture time
Time frame: up to 10 minutes
Performance time
Time frame: up to 10 minutes
Number of punctures
Time frame: up to 10 minutes
pain 5 after block
Time frame: up to 5 minutes
pain 10 after block
Time frame: up to 10 minutes
pain 15 after block
Time frame: up to 15 minutes
pain 20 after block
Time frame: up to 20 minutes
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 13 Feb 2024.
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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.
khaireddine Raddaoui, MD principal investigator
Tunis El Manar University
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 percapsular nerve group block in people with Hip Fracture and Analgesia, 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 2 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 13 Feb 2024. 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 (time frame: up to 30 minutes). 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 13 Feb 2024.