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

NCT06582667 | Not Yet Recruiting DMC

• 1 other identifier: PENG block with antithrombotic
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hip Fracture; Antithrombotic Therapy; PENG Block

Keywords

antithrombotic therapy; PENG block

Outcome Measures

Primary Outcomes (3)

• Incidence of Hematoma Formation

  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:

  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

  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 Outcomes (5)

• Incidence of Nerve Injury

  after performing the block ( 12 hours after surgery) and subsequent assessments on the next 48 hours

• Postoperative quadriceps strength

  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)

  On the same day of surgery ( 12 hours after surgery) and first day postoperative

• - Perioperative opiate use

  from the end of surgery to 48 hours postoperative

• length of hospital stay in days

  from the date of admission to the date of discharge

Study Arms (2)

group A: PENG block in hip fracture with antithrombotic therapy

EXPERIMENTAL

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

Procedure: PENG block

group C: PENG block in hip fracture without antithrombotic therapy

EXPERIMENTAL

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

Procedure: PENG block

Interventions

PENG block PROCEDURE

US guided PENG block in hip fracture without anti thrombotic therapy

Also known as: US guided PENG block in hip fracture with anti thrombotic therapy

group A: PENG block in hip fracture with antithrombotic therapy; group C: PENG block in hip fracture without antithrombotic therapy

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Medicine

Alexandria, Egypt

Location

Related Publications (1)

• 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.

  PMID: 30063657 BACKGROUND

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Central Study Contacts

Wessam El-amrawy, myself

CONTACT

01280998606; wesam.amrawy@alexu.edu.eg

tarek ismail, study director

CONTACT

01001467166; drtarek.anesth@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: outcomes assessor
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: group I: PENG block with antithrombotic therapy group II: PENG block without antithrombotic therapy

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: September 3, 2024
• Study Start: September 17, 2024
• Primary Completion: January 17, 2025
• Study Completion: April 17, 2025
• Last Updated: September 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: around 1 year
• Access Criteria: for anyone interested in regional blocks

Locations

EG (1)