An interventional study of PENG block in Hip Fracture, Antithrombotic Therapy and PENG Block, sponsored by Alexandria University. Not yet recruiting at 1 site in Egypt. Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-09-03.
Sponsored by Alexandria University · Not applicable, Interventional, and Health services research
PENG block will be done on patients with hip fracture either receiving antithrombotic therapy or not under ultrasound guidance
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
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's planned enrollment of 100 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Alexandria University is the lead sponsor of 570 studies on the registry; 126 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
50 patients will receive US guided PENG block and on antithrombotic therapy in hip fracture
Procedure: PENG block
50 patients will receive US guided PENG block without antithrombotic therapy in hip fracture
Procedure: PENG block
US guided PENG block in hip fracture without anti thrombotic therapy
Also known as: US guided PENG block in hip fracture with anti thrombotic therapy
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.
Time frame: first 48 hours postintervention
Bloody Tab on the Needle:
Presence of blood on the needle during the performance of the PENG block.
Time frame: 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
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.
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.
Time frame: 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).
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)
15 values score ranges from 0-150 ,excellent \>135, good \> 122 and \< 135, moderate \>90 and \< 121, poor \< 90
Time frame: 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
Time frame: 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
Time frame: from the date of admission to the date of discharge
Plan to share: Yes — i would like to share my data with other researchers for more citations
Supporting information: Study protocol, Sap, Icf
This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Alexandria University