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NCT Number: NCT06582667

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

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

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Key information

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PENG block

Procedure

US guided PENG block in hip fracture without anti thrombotic therapy

Other names: US guided PENG block in hip fracture with anti thrombotic therapy

Primary outcomes

  1. Incidence of Hematoma Formation

    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.

  2. Bloody Tab on the Needle:

    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.

  3. Rest and mobilization pain by numerical rating scale

    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

Secondary outcomes

  1. Incidence of Nerve Injury

    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.

  2. Postoperative quadriceps strength

    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).

  3. 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)

    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

  4. - Perioperative opiate use

    Time frame: from the end of surgery to 48 hours postoperative

    will be calculated over 48 hours in milligrams

  5. length of hospital stay in days

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Wessam El-amrawy, myself

CONTACT

[email protected]

01280998606

tarek ismail, study director

CONTACT

[email protected]

01001467166

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 3, 2024
Registry last updated
Sep 3, 2024

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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