Assessing the Effectiveness and Safety of Pericapsular Nerve Group (PENG) Block in Hip Fracture Patients on Antithrombotic Therapy

Not Applicable

Not yet recruiting

• Conditions: Hip Fracture; Antithrombotic Therapy; PENG Block
• Interventions: Procedure: PENG block

• Registration Number: NCT06582667
• Lead Sponsor: Alexandria University

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

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-08-08
• Study First Submitted QC: 2024-08-30
• Last Update Submitted: 2024-08-30
• Study First Posted: 2024-09-03
• Last Update Posted: 2024-09-03
• Study Start: 2024-09-17
• Primary Completion: 2025-01-17
• Study Completion: 2025-04-17

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A: PENG block in hip fracture with antithrombotic therapy	PENG block	50 patients will receive US guided PENG block and on antithrombotic therapy in hip fracture
group C: PENG block in hip fracture without antithrombotic therapy	PENG block	50 patients will receive US guided PENG block without antithrombotic therapy in hip fracture

Primary Outcome Measures

Name	Time	Method
Incidence of Hematoma Formation	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:	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	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

Secondary Outcome Measures

Name	Time	Method
Postoperative quadriceps strength	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).
length of hospital stay in days	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
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)	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
Incidence of Nerve Injury	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.
- Perioperative opiate use	from the end of surgery to 48 hours postoperative	will be calculated over 48 hours in milligrams

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Alexandria, Egypt