Hip FracturePENG BlockNCT06582667
Assessing the Effectiveness and Safety of Pericapsular Nerve Group (PENG) Block in Hip Fracture Patients on Antithrombotic Therapy
A study testing PENG block in people with Hip Fracture and Antithrombotic Therapy, run by Alexandria University at 1 site in Egypt.
Trial summary
PENG block will be done on patients with hip fracture either receiving antithrombotic therapy or not under ultrasound guidance Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Hip Fracture, Antithrombotic Therapy, PENG Block
- What is being tested?
- 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
- 17 Sep 2024to 17 Apr 2025
- 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 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 years or older
- diagnosis of hip fracture
- scheduled for surgical intervention within 48 hours
- Informed consent obtained.
Who cannot join
- Allergy to local anesthetics,
- Contraindications to the PENG block
- inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine
Alexandria
wessam El-amrawy, myself, 01280998606, wesam.amrawy@alexu.edu.eg
tarek ismail, investigator, 01001467166, drtarek.anesth@gmail.com
About this study
Official title: Assessing the Effectiveness and Safety of Pericapsular Nerve Group (PENG) Block in Hip Fracture Patients on Antithrombotic Therapy: A Randomized Controlled Trial
PENG block will be done on patients with hip fracture either receiving antithrombotic therapy or not under ultrasound guidance
Read the detailed description
Patients will be randomized into two groups:
Group A (Antithrombotic Therapy Group): 50 Patients on continuous antithrombotic therapy will receive BENG block.
Group C (Control Group): 50 Patients without antithrombotic therapy will receive BENG block.
Intervention:
PENG Block: Standardized administration of the PENG block will be performed by experienced anesthesiologists for both groups using ultrasound device.
The patients will be subjected to standard monitoring and received nasal cannula oxygen (2 L/min). Midazolam (1-2 mg) will be administered intravenously for light sedation.
Under sterile conditions, a low-frequency curvilinear probe of ultrasound (SonoSite S-Nerve Machine, Fujifilm) is initially placed in a transverse plane over the anterior inferior iliac spine, and is then rotated parallel to the pubic ramus to obtain a short-axis view of the iliopsoas muscle and tendon lying on the ramus pubic adjacent to the iliopubic eminence. After skin infiltration with 1-3 mL 1% lidocaine, a 23 G, 70 mm insulated block needle is inserted in-plane in a lateral-to- medial direction to place the tip in the musculofascial plane between the psoas tendon and the pubic ramus. A total of 20 mL 0.5% bupivacaine (AstraZeneca, EGYPT) is injected slowly in 5 mL increments with intermittent aspiration and under constant ultrasound surveillance for adequate fluid spread. Thirty minutes after the block completion, standardized endotracheal general anesthesia is induced with propofol (2-2.5 mg/kg), fentanyl (0.5-1,5 μg/kg), and atracurium (0.5 mg/kg).maintenance of anesthesia is done with sevoflurane (2-2.5%) with o2and air 60:40% Antithrombotic Management: Clear protocols for managing antithrombotic therapy in Group A will be implemented, considering perioperative bleeding risk
- Conditions
- Hip Fracture, Antithrombotic Therapy, PENG Block
- Being tested
- PENG block
- Keywords
- antithrombotic therapy, PENG 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.
PENG blockProcedure or surgery
Also called US guided PENG block in hip fracture with anti thrombotic therapy
US guided PENG block in hip fracture without anti thrombotic therapy
| Study group | Role | What they receive |
|---|---|---|
| group A: PENG block in hip fracture with antithrombotic therapy | Experimental | 50 patients will receive US guided PENG block and on antithrombotic therapy in hip fracture Receives: Procedure: PENG block |
| group C: PENG block in hip fracture without antithrombotic therapy | Experimental | 50 patients will receive US guided PENG block without antithrombotic therapy in hip fracture Receives: Procedure: PENG block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Hematoma Formation
The occurrence and severity of hematomas at the PENG block site. Measurement: Regular clinical examinations and imaging studies to assess for hematoma formation.
Measured: first 48 hours postintervention
Bloody Tab on the Needle:
Presence of blood on the needle during the performance of the PENG block.
Measured: immediately during the procedure ( first 10 minutes after PENG block)
Rest and mobilization pain by numerical rating scale
post intervention to be assessed 0-10
Measured: 1 hour and 6 hours after surgery, on the same day of surgery (D 0) and first day postoperative(D 1) at 8 a.m., 1 p.m. and 6 p.m.
Secondary outcomes (5)
Incidence of Nerve Injury
Any signs of sensory or motor deficits, paresthesia, or neuropathic pain related to nerve injury or compression due to hematoma formation.
Measured: after performing the block ( 12 hours after surgery) and subsequent assessments on the next 48 hours
Postoperative quadriceps strength
Quadriceps strength is assessed using the knee extension Test and Oxford muscle strength grading with grouped scores of intact (5/5), reduced (1-4/5) and absent (0/5).
Measured: first day postoperative postoperative (12 hours after surgery)
The quality of Postoperative functional recovery and the variations and differences between groups will be assessed using the validated arabic version of the quality-of-recovery 15-items score (QoR-15)
15 values score ranges from 0-150 ,excellent >135, good > 122 and < 135, moderate >90 and < 121, poor < 90
Measured: On the same day of surgery ( 12 hours after surgery) and first day postoperative
- Perioperative opiate use
will be calculated over 48 hours in milligrams
Measured: from the end of surgery to 48 hours postoperative
length of hospital stay in days
the number of days spent in the hospital will be calculated at the date of discharge the starting day is the date of admission called day 1 and all days spent in the hospital will be counted till the day of going home and this expected to be from 3-10 days after operation
Measured: from the date of admission to the date of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start17 Sep 2024 (estimated)
- Primary completion17 Jan 2025 (estimated)
- Study completion17 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- group I: PENG block with antithrombotic therapy group II: PENG block without antithrombotic therapy
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582667
- Sponsor's protocol ID
- PENG block with antithrombotic
- Acronym
- PENG Block
- Status last verified
- Jul 2024
- First submitted
- 8 Aug 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: i would like to share my data with other researchers for more citations
Publications
Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
PubMed 30063657
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness and Safety of Pericapsular Nerve Group (PENG) Block in Hip Fracture Patients on Antithrombotic Therapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06582667
- Acronym / sponsor ID
- PENG Block / PENG block with antithrombotic
- Conditions
- Hip Fracture, Antithrombotic Therapy, PENG Block
- Keywords
- antithrombotic therapy, PENG block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 17 Sep 2024 (estimated)
- Primary completion
- 17 Jan 2025 (estimated)
- Study completion
- 17 Apr 2025 (estimated)
- First posted
- 3 Sep 2024 (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.
PENG block will be done on patients with hip fracture either receiving antithrombotic therapy or not under ultrasound guidance
Detailed description
Patients will be randomized into two groups:
Group A (Antithrombotic Therapy Group): 50 Patients on continuous antithrombotic therapy will receive BENG block.
Group C (Control Group): 50 Patients without antithrombotic therapy will receive BENG block.
Intervention:
PENG Block: Standardized administration of the PENG block will be performed by experienced anesthesiologists for both groups using ultrasound device.
The patients will be subjected to standard monitoring and received nasal cannula oxygen (2 L/min). Midazolam (1-2 mg) will be administered intravenously for light sedation.
Under sterile conditions, a low-frequency curvilinear probe of ultrasound (SonoSite S-Nerve Machine, Fujifilm) is initially placed in a transverse plane over the anterior inferior iliac spine, and is then rotated parallel to the pubic ramus to obtain a short-axis view of the iliopsoas muscle and tendon lying on the ramus pubic adjacent to the iliopubic eminence. After skin infiltration with 1-3 mL 1% lidocaine, a 23 G, 70 mm insulated block needle is inserted in-plane in a lateral-to- medial direction to place the tip in the musculofascial plane between the psoas tendon and the pubic ramus. A total of 20 mL 0.5% bupivacaine (AstraZeneca, EGYPT) is injected slowly in 5 mL increments with intermittent aspiration and under constant ultrasound surveillance for adequate fluid spread. Thirty minutes after the block completion, standardized endotracheal general anesthesia is induced with propofol (2-2.5 mg/kg), fentanyl (0.5-1,5 μg/kg), and atracurium (0.5 mg/kg).maintenance of anesthesia is done with sevoflurane (2-2.5%) with o2and air 60:40% Antithrombotic Management: Clear protocols for managing antithrombotic therapy in Group A will be implemented, considering perioperative bleeding risk
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- group I: PENG block with antithrombotic therapy group II: PENG block without antithrombotic therapy
| Arm | Type | Receives |
|---|---|---|
| group A: PENG block in hip fracture with antithrombotic therapy | Experimental | Procedure: PENG block50 patients will receive US guided PENG block and on antithrombotic therapy in hip fracture |
| group C: PENG block in hip fracture without antithrombotic therapy | Experimental | Procedure: PENG block50 patients will receive US guided PENG block without antithrombotic therapy in hip fracture |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age 65 years or older
- diagnosis of hip fracture
- scheduled for surgical intervention within 48 hours
- Informed consent obtained.
Key exclusion criteria (3 listed)
- Allergy to local anesthetics,
- Contraindications to the PENG block
- inability to provide informed consent.
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 blockAlso: US guided PENG block in hip fracture with anti thrombotic therapyUS guided PENG block in hip fracture without anti thrombotic therapy | Procedure or surgery | group A: PENG block in hip fracture with antithrombotic therapy, group C: PENG block in hip fracture without antithrombotic therapy |
Primary outcome
Incidence of Hematoma Formation
Time frame: first 48 hours postintervention
The occurrence and severity of hematomas at the PENG block site. Measurement: Regular clinical examinations and imaging studies to assess for hematoma formation.
Bloody Tab on the Needle:
Time frame: immediately during the procedure ( first 10 minutes after PENG block)
Presence of blood on the needle during the performance of the PENG block.
Rest and mobilization pain by numerical rating scale
Time frame: 1 hour and 6 hours after surgery, on the same day of surgery (D 0) and first day postoperative(D 1) at 8 a.m., 1 p.m. and 6 p.m.
post intervention to be assessed 0-10
5 secondary outcomes
Incidence of Nerve Injury
Time frame: after performing the block ( 12 hours after surgery) and subsequent assessments on the next 48 hours
Postoperative quadriceps strength
Time frame: first day postoperative postoperative (12 hours after surgery)
The quality of Postoperative functional recovery and the variations and differences between groups will be assessed using the validated arabic version of the quality-of-recovery 15-items score (QoR-15)
Time frame: On the same day of surgery ( 12 hours after surgery) and first day postoperative
- Perioperative opiate use
Time frame: from the end of surgery to 48 hours postoperative
length of hospital stay in days
Time frame: from the date of admission to the date of discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Background: PubMed 30063657Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
- Individual participant dataSharing planned: Yes. i would like to share my data with other researchers for more citations
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PENG block in people with Hip Fracture and Antithrombotic Therapy, run by Alexandria 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 4 inclusion and 3 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 3 Sep 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 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 Wessam El-amrawy, myself (01280998606, wesam.amrawy@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Hematoma Formation (time frame: first 48 hours postintervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06582667, which also lists 1 linked publication.
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 3 Sep 2024.