NCT05365555

Brief Summary

The goal of this study is to compare the analgesic effect of a blind fascia iliaca compartment block to an ultrasound-guided femoral nerve block in patients that present to the emergency department with hip fractures.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 9, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

11 months

First QC Date

April 27, 2022

Last Update Submit

May 3, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mean Change from Baseline in Pain Scores on the Numeric Rating Scale (0 to 10, where 10 is Maximum Pain) at 30 minutes after Administration of Block, at Rest and During Active Hip Flexion

    Change in reported pain score should be at least one whole unit on the numeric rating scale.

    Measured 30 minutes after administered nerve block.

Secondary Outcomes (2)

  • Ratio of Failed Blocks

    Through study completion, an average of 1 year

  • Rate of Complications

    Through study completion, an average of 1 year

Study Arms (2)

Fascia Iliaca Compartment Block (FICB)

Participants with a radiologically verified hip fracture receiving a FICB using a blind technique guided by anatomical landmarks.

Procedure: Fascia Iliaca Compartment BlockDrug: Ropivacaine

Femoral Nerve Block (FNB)

Participants with a radiologically verified hip fracture receiving a FNB using ultrasound guidance for direct nerve visualisation.

Procedure: Femoral Nerve BlockDrug: Ropivacaine

Interventions

Blind technique.

Also known as: Peripheral nerve block, Regional anesthesia
Fascia Iliaca Compartment Block (FICB)

Ultrasound guided.

Also known as: Peripheral nerve block, Regional anesthesia
Femoral Nerve Block (FNB)

Ropivacaine dosed according to local guidelines.

Also known as: Local anesthetic, Naropin
Fascia Iliaca Compartment Block (FICB)Femoral Nerve Block (FNB)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult patients in the emergency department with a radiologically verified hip fracture eligible for a peripheral nerve block according to local guidelines

You may qualify if:

  • Adult emergency department patient over 18 years of age with a radiologically verified fracture classified as hip fracture that are eligible for a peripheral nerve block according to local guidelines

You may not qualify if:

  • Multi-system trauma
  • Isolated pelvic or diaphyseal femur fracture
  • Patients unable to communicate regardless of reason
  • Patients with contraindications to receiving a peripheral nerve block with an amide local anaesthetic according to local guidelines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akutmottagningen US Östergötland

Linköping, Östergötland County, 58185, Sweden

RECRUITING

MeSH Terms

Conditions

Hip Fractures

Interventions

Anesthesia, ConductionRopivacaineAnesthetics, Local

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and AnalgesiaAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic Uses

Study Officials

  • Daniel Wilhelms, PhD, MD

    University Hospital, Linköping

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Emergency Department Head of Research

Study Record Dates

First Submitted

April 27, 2022

First Posted

May 9, 2022

Study Start

May 1, 2022

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

May 9, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations