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

NCT ID: NCT06582667

Last Updated: 2024-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-17

Study Completion Date

2025-04-17

Brief Summary

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PENG block will be done on patients with hip fracture either receiving antithrombotic therapy or not under ultrasound guidance

Detailed Description

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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

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Hip Fracture Antithrombotic Therapy PENG Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

group I: PENG block with antithrombotic therapy group II: PENG block without antithrombotic therapy
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors
outcomes assessor

Study Groups

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group A: PENG block in hip fracture with antithrombotic therapy

50 patients will receive US guided PENG block and on antithrombotic therapy in hip fracture

Group Type EXPERIMENTAL

PENG block

Intervention Type PROCEDURE

US guided PENG block in hip fracture without anti thrombotic therapy

group C: PENG block in hip fracture without antithrombotic therapy

50 patients will receive US guided PENG block without antithrombotic therapy in hip fracture

Group Type EXPERIMENTAL

PENG block

Intervention Type PROCEDURE

US guided PENG block in hip fracture without anti thrombotic therapy

Interventions

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PENG block

US guided PENG block in hip fracture without anti thrombotic therapy

Intervention Type PROCEDURE

Other Intervention Names

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US guided PENG block in hip fracture with anti thrombotic therapy

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculty of Medicine

Alexandria, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Wessam El-amrawy, myself

Role: CONTACT

01280998606

tarek ismail, study director

Role: CONTACT

01001467166

Facility Contacts

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wessam El-amrawy, myself

Role: primary

01280998606

tarek ismail, investigator

Role: backup

01001467166

References

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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.

Reference Type BACKGROUND
PMID: 30063657 (View on PubMed)

Other Identifiers

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PENG block with antithrombotic

Identifier Type: -

Identifier Source: org_study_id

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