NCT05002725

Brief Summary

Neck of femur (NOF) fracture is a common presentation to the emergency department, particularly in our older population. NOF fracture is associated with a high social and economic cost with significant effects on patients' quality of life. Analgesia and ambulation are important determinants of outcome following NOF surgery. We propose to compare whether PENG or Femoral Nerve Block is associated with a greater degree of quadriceps motor dysfunction.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 28, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

August 12, 2021

Status Verified

August 1, 2021

Enrollment Period

7 months

First QC Date

August 4, 2021

Last Update Submit

August 4, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quadriceps Motor Block

    Presence or absence of motor block

    20 mins post procedure

Secondary Outcomes (5)

  • Pain

    20 mins post procedure

  • 12 hr Pain

    20 mins post procedure

  • 24 hr Pain

    20 mins post procedure

  • Quadriceps Motor block

    24 hours post op

  • cumulative opiate consumption

    24 hours post op

Study Arms (2)

PENG

EXPERIMENTAL

An ultrasound guided PENG catheter will be inserted. 20ml of 1.5% lidocaine will be administered.

Drug: Lidocain

Femoral Block

ACTIVE COMPARATOR

An ultrasound guided Femoral Nerve catheter will be inserted. 20ml of 1.5% lidocaine will be administered.

Drug: Lidocain

Interventions

300mg (20ml) will be injected

Femoral BlockPENG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients scheduled for operative repair of hip fracture Patient age 16 years or more ASA I - III

You may not qualify if:

  • Patient refusal Coagulopathy Local infection Allergy to Local Anaesthetics Significant cognitive impairment (4AT score\>=4) Weight \<60kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cork University Hospital

Cork, Ireland

RECRUITING

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Central Study Contacts

Brian D O'Donnell

CONTACT

Brian O'Donnell

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
This will be a double blinded study where patients and assessors are blinded to the technique used. The operator performing the block cannot be blinded. It will not be possible to tell from the appearance of the catheter whether it is a femoral nerve catheter or PENG catheter
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Senior Lecturer

Study Record Dates

First Submitted

August 4, 2021

First Posted

August 12, 2021

Study Start

January 28, 2021

Primary Completion

September 1, 2021

Study Completion

December 1, 2021

Last Updated

August 12, 2021

Record last verified: 2021-08

Locations