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

August 30, 2024 updated by: Alexandria University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Procedure: PENG block
US guided PENG block in hip fracture without anti thrombotic therapy
Other Names:
  • US guided PENG block in hip fracture with anti thrombotic therapy
Experimental: group C: PENG block in hip fracture without antithrombotic therapy
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
Other Names:
  • US guided PENG block in hip fracture with anti thrombotic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
first 48 hours postintervention
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.
immediately during the procedure ( first 10 minutes after PENG block)
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
after performing the block ( 12 hours after surgery) and subsequent assessments on the next 48 hours
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).
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)
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
On the same day of surgery ( 12 hours after surgery) and first day postoperative
- Perioperative opiate use
Time Frame: from the end of surgery to 48 hours postoperative
will be calculated over 48 hours in milligrams
from the end of surgery to 48 hours postoperative
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
from the date of admission to the date of discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 17, 2024

Primary Completion (Estimated)

January 17, 2025

Study Completion (Estimated)

April 17, 2025

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

August 30, 2024

First Posted (Actual)

September 3, 2024

Study Record Updates

Last Update Posted (Actual)

September 3, 2024

Last Update Submitted That Met QC Criteria

August 30, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PENG block with antithrombotic

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

i would like to share my data with other researchers for more citations

IPD Sharing Time Frame

around 1 year

IPD Sharing Access Criteria

for anyone interested in regional blocks

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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