Hip FractureNCT06878963
COmparison of PENG Block and SIFICB in Hip Fracture Surgeries
A study testing PENG Block and SIFICB Block in people with Hip Fracture and Pericapsular Nerve Group Block (PENG Block), run by Adiyaman University Research Hospital.
Trial summary
The aim of this study is to compare the effectiveness of the PENG block and SIFIB in facilitating the positioning for neuroaxial anesthesia and their impact on the quality of postoperative analgesia. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Hip Fracture, Pericapsular Nerve Group Block (PENG Block), Suprainguinal Fasya Iliaca Block
- What is being tested?
- PENG Block and SIFICB Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hip fractures
- 40-80 years
Who cannot join
- Contraindicated to spinal anesthesia
- allergy to local anesthetics
- severe peripheral neuropathy
- mental disorders
About this study
Official title: Comparison of the Effects of Pericapsular Nerve Group Block and Suprainguinal Fascia Iliaca Compartment Block on Neuraxial Anesthesia Positioning and Postoperative Analgesia in Hip Fracture Surgeries
The aim of this study is to compare the effectiveness of the PENG block and SIFIB in facilitating the positioning for neuroaxial anesthesia and their impact on the quality of postoperative analgesia.
Read the detailed description
Hip fractures are a significant health problem that leads to severe morbidity and mortality in elderly individuals. Neuroaxial anesthesia is often preferred in the surgical treatment of these patients due to its ability to maintain hemodynamic stability and manage postoperative analgesia. However, the severe pain accompanying these fractures makes it difficult to achieve an appropriate position for neuroaxial anesthesia, which complicates both patient comfort and the work of the anesthesia provider.
In recent years, peripheral nerve blocks have emerged as an effective method to overcome this challenge. The pericapsular nerve group (PENG) block and supra-inguinal fascia iliaca compartment block (SIFIB) are commonly used techniques for the management of pain related to hip fractures. While studies comparing the analgesic efficacy of these two blocks exist in the literature, data regarding their specific effects on neuroaxial anesthesia positioning are limited.
In this study, patients scheduled for surgery due to hip fractures will receive either a pericapsular nerve group (PENG) block or a supra-inguinal fascia iliaca compartment block (SIFIB). Both block procedures will be performed under ultrasound guidance and sterile conditions, following standard protocols. After the block procedure, the time taken for patients to transition into the neuroaxial anesthesia position (primary outcome) will be measured, and the level of pain experienced during positioning will be assessed using the Visual Analog Scale (VAS).
In the postoperative period, VAS scores and additional analgesic requirements (secondary outcomes) will be recorded for 24 hours. Demographic data (age, gender, body mass index) and comorbidities will also be collected and used for intergroup comparisons. Throughout the study, patient privacy will be respected, and the collected data will be analyzed anonymously.
The study will be conducted in accordance with the Declaration of Helsinki, and informed consent will be obtained from all participants.
- Conditions
- Hip Fracture, Pericapsular Nerve Group Block (PENG Block), Suprainguinal Fasya Iliaca Block
- Being tested
- PENG Block, SIFICB Block
- Keywords
- Hip fracture, Pericapsular nerve group block, Suprainguinal fasya iliaca block, Patient positioning
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG BlockProcedure or surgery
The PENG block will be performed on the patient with the injection of local anesthesia under ultrasound guidance in the femoral region, beneath the biceps tendon.
SIFICB BlockProcedure or surgery
The SIFIB block will be performed on the patient with the injection of local anesthetic between the iliac fascia and iliac muscle in the femoral region, under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Group P | Experimental | The PENG block will be performed on the patient with the injection of local anesthesia under ultrasound guidance in the femoral region, beneath the biceps tendon. Receives: Procedure: PENG Block |
| Group S | Experimental | The SIFIB block will be performed on the patient with the injection of local anesthetic between the iliac fascia and iliac muscle in the femoral region, under ultrasound guidance. Receives: Procedure: SIFICB Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient positioning
In patients with hip fractures, during spinal anesthesia, the angle between the patient's back and the operating table will be recorded while positioning the patient.
Measured: During neuroaxial block procedure
Secondary outcomes (1)
Visual Analog Scale (VAS) score
VAS score is a measurement instrument for subjective characteristics of pain. VAS score range from 0 to 10. 0 refers to no pain and 10 refers to the worst pain ever had
Measured: During neuroaxial block procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nezir Yılmaz, Adiyaman University Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878963
- Sponsor's protocol ID
- ADYU-ANS-NY-008
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Pericapsular Nerve Group Block and Suprainguinal Fascia Iliaca Compartment Block on Neuraxial Anesthesia Positioning and Postoperative Analgesia in Hip Fracture Surgeries
- ClinicalTrials.gov ID
- NCT06878963
- Acronym / sponsor ID
- ADYU-ANS-NY-008
- Conditions
- Hip Fracture, Pericapsular Nerve Group Block (PENG Block), Suprainguinal Fasya Iliaca Block
- Keywords
- Hip fracture, Pericapsular nerve group block, Suprainguinal fasya iliaca block, Patient positioning
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 17 Mar 2025 (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.
The aim of this study is to compare the effectiveness of the PENG block and SIFIB in facilitating the positioning for neuroaxial anesthesia and their impact on the quality of postoperative analgesia.
Detailed description
Hip fractures are a significant health problem that leads to severe morbidity and mortality in elderly individuals. Neuroaxial anesthesia is often preferred in the surgical treatment of these patients due to its ability to maintain hemodynamic stability and manage postoperative analgesia. However, the severe pain accompanying these fractures makes it difficult to achieve an appropriate position for neuroaxial anesthesia, which complicates both patient comfort and the work of the anesthesia provider.
In recent years, peripheral nerve blocks have emerged as an effective method to overcome this challenge. The pericapsular nerve group (PENG) block and supra-inguinal fascia iliaca compartment block (SIFIB) are commonly used techniques for the management of pain related to hip fractures. While studies comparing the analgesic efficacy of these two blocks exist in the literature, data regarding their specific effects on neuroaxial anesthesia positioning are limited.
In this study, patients scheduled for surgery due to hip fractures will receive either a pericapsular nerve group (PENG) block or a supra-inguinal fascia iliaca compartment block (SIFIB). Both block procedures will be performed under ultrasound guidance and sterile conditions, following standard protocols. After the block procedure, the time taken for patients to transition into the neuroaxial anesthesia position (primary outcome) will be measured, and the level of pain experienced during positioning will be assessed using the Visual Analog Scale (VAS).
In the postoperative period, VAS scores and additional analgesic requirements (secondary outcomes) will be recorded for 24 hours. Demographic data (age, gender, body mass index) and comorbidities will also be collected and used for intergroup comparisons. Throughout the study, patient privacy will be respected, and the collected data will be analyzed anonymously.
The study will be conducted in accordance with the Declaration of Helsinki, and informed consent will be obtained from all participants.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group P | Experimental | Procedure: PENG BlockThe PENG block will be performed on the patient with the injection of local anesthesia under ultrasound guidance in the femoral region, beneath the biceps tendon. |
| Group S | Experimental | Procedure: SIFICB BlockThe SIFIB block will be performed on the patient with the injection of local anesthetic between the iliac fascia and iliac muscle in the femoral region, under ultrasound guidance. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hip fractures
- 40-80 years
Key exclusion criteria (4 listed)
- Contraindicated to spinal anesthesia
- allergy to local anesthetics
- severe peripheral neuropathy
- mental disorders
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 |
|---|---|---|
| PENG BlockThe PENG block will be performed on the patient with the injection of local anesthesia under ultrasound guidance in the femoral region, beneath the biceps tendon. | Procedure or surgery | Group P |
| SIFICB BlockThe SIFIB block will be performed on the patient with the injection of local anesthetic between the iliac fascia and iliac muscle in the femoral region, under ultrasound guidance. | Procedure or surgery | Group S |
Primary outcome
Patient positioning
Time frame: During neuroaxial block procedure
In patients with hip fractures, during spinal anesthesia, the angle between the patient's back and the operating table will be recorded while positioning the patient.
1 secondary outcome
Visual Analog Scale (VAS) score
Time frame: During neuroaxial block procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PENG Block and SIFICB Block in people with Hip Fracture and Pericapsular Nerve Group Block (PENG Block), run by Adiyaman University Research Hospital.
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 4 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: opening soon, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Patient positioning (time frame: During neuroaxial 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 17 Mar 2025.