Clinical trial NCT06582667: Assessing the Effectiveness and Safety of Pericapsular Nerve Group (PENG) Block in Hip Fracture Patients on Antithrombotic Therapy
Official title: Assessing the Effectiveness and Safety of Pericapsular Nerve Group (PENG) Block in Hip Fracture Patients on Antithrombotic Therapy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hip Fracture
Antithrombotic Therapy
PENG Block
Keywords: antithrombotic therapy
PENG block
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: group I: PENG block with antithrombotic therapy group II: PENG block without antithrombotic therapy
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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

Eligibility criteria: Inclusion Criteria:

* Age 65 years or older
* diagnosis of hip fracture
* scheduled for surgical intervention within 48 hours
* Informed consent obtained.

Exclusion Criteria:

* Allergy to local anesthetics,
* Contraindications to the PENG block
* inability to provide informed consent.

Primary outcomes:
measure: Incidence of Hematoma Formation
timeFrame: first 48 hours postintervention
measure: Bloody Tab on the Needle:
timeFrame: immediately during the procedure ( first 10 minutes after PENG block)
measure: Rest and mobilization pain by numerical rating scale
timeFrame: 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:
measure: Incidence of Nerve Injury
timeFrame: after performing the block ( 12 hours after surgery) and subsequent assessments on the next 48 hours
measure: Postoperative quadriceps strength
timeFrame: first day postoperative postoperative (12 hours after surgery)
measure: 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)
timeFrame: On the same day of surgery ( 12 hours after surgery) and first day postoperative
measure: - Perioperative opiate use
timeFrame: from the end of surgery to 48 hours postoperative
measure: length of hospital stay in days
timeFrame: from the date of admission to the date of discharge
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
citation: 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.