Faculty of Medicine
Alexandria, Egypt
Location contact
tarek ismail, investigator
CONTACT
wessam El-amrawy, myself
CONTACT
NCT Number: NCT06582667
PENG block will be done on patients with hip fracture either receiving antithrombotic therapy or not under ultrasound guidance
Trial opening soon.
Get Notified65 year–85 year
All sexes
Interventional
Not applicable
Alexandria, Egypt
tarek ismail, investigator
CONTACT
wessam El-amrawy, myself
CONTACT
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
US guided PENG block in hip fracture without anti thrombotic therapy
Other names: US guided PENG block in hip fracture with anti thrombotic therapy
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.
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.
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
Time frame: after performing the block ( 12 hours after surgery) and subsequent assessments on the next 48 hours
Any signs of sensory or motor deficits, paresthesia, or neuropathic pain related to nerve injury or compression due to hematoma formation.
Time frame: first day postoperative postoperative (12 hours after surgery)
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).
Time frame: On the same day of surgery ( 12 hours after surgery) and first day postoperative
15 values score ranges from 0-150 ,excellent >135, good > 122 and < 135, moderate >90 and < 121, poor < 90
Time frame: from the end of surgery to 48 hours postoperative
will be calculated over 48 hours in milligrams
Time frame: from the date of admission to the date of discharge
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
Contact information is provided by the study sponsor or research team.
Wessam El-amrawy, myself
CONTACT
tarek ismail, study director
CONTACT
Alexandria University
Other
Assessing the Effectiveness and Safety of Pericapsular Nerve Group (PENG) Block in Hip Fracture Patients on Antithrombotic Therapy: A Randomized Controlled Trial
Acronym: PENG Block
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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