Health TrialsbyHealthPanel

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

ConditionsHip FractureAntithrombotic TherapyPENG Block
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-85
SponsorAlexandria University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 65 years or older

diagnosis of hip fracture

scheduled for surgical intervention within 48 hours

Informed consent obtained.

Disqualifiers

Allergy to local anesthetics,

Contraindications to the PENG block

inability to provide informed consent.

Trial design

Design model

Parallel

Treatments tested in this trial

  • PENG block

    Procedure/Surgery

    US guided PENG block in hip fracture without anti thrombotic therapy

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: group A: PENG block in hip fracture with antithrombotic therapyExperimental treatment 1 intervention
Group B: group C: PENG block in hip fracture without antithrombotic therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
first 48 hours postintervention
2

Bloody Tab on the Needle:

Presence of blood on the needle during the performance of the PENG block.

Time frame
immediately during the procedure ( first 10 minutes after PENG block)
3

Rest and mobilization pain by numerical rating scale

post intervention to be assessed 0-10

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.

Secondary outcomes

1

Incidence of Nerve Injury

Any signs of sensory or motor deficits, paresthesia, or neuropathic pain related to nerve injury or compression due to hematoma formation.

Time frame
after performing the block ( 12 hours after surgery) and subsequent assessments on the next 48 hours
2

Postoperative quadriceps strength

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).

Time frame
first day postoperative postoperative (12 hours after surgery)
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)

15 values score ranges from 0-150 ,excellent \>135, good \> 122 and \< 135, moderate \>90 and \< 121, poor \< 90

Time frame
On the same day of surgery ( 12 hours after surgery) and first day postoperative
4

- Perioperative opiate use

will be calculated over 48 hours in milligrams

Time frame
from the end of surgery to 48 hours postoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alexandria University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: