Blind Fascia Iliaca Compartment Block Compared to Ultrasound-guided Femoral Nerve Block in Patients With Hip Fractures

NCT ID: NCT05365555

Last Updated: 2022-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Hip fractures often present to the emergency department and elderly, already fragile, patients are overrepresented. The pain associated with a hip fracture can be severe and have deleterious effects on the patient. Many studies, and a Cochrane review, have shown that a peripheral nerve block provides good pain relief and has many benefits compared to traditional pain relief, such as intravenous morphine. There is less consensus regarding which kind of nerve block, and which technique, is best to use. Many studies compared different kinds of nerve blocks to traditional methods, or more recently compared different kinds of ultrasound-guided techniques to each other.

This study proposes to compare the widely used technique of a blind fascia iliaca compartment block (FICB) to an ultrasound-guided femoral nerve block (FNB) that is currently being rolled out locally as an alternative. During the implementation period of this new clinical routine, it will be possible to compare the efficacy of FICB and FNB in reducing participant-reported pain.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hip Fractures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fascia Iliaca Compartment Block (FICB)

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

Fascia Iliaca Compartment Block

Intervention Type PROCEDURE

Blind technique.

Ropivacaine

Intervention Type DRUG

Ropivacaine dosed according to local guidelines.

Femoral Nerve Block (FNB)

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

Femoral Nerve Block

Intervention Type PROCEDURE

Ultrasound guided.

Ropivacaine

Intervention Type DRUG

Ropivacaine dosed according to local guidelines.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fascia Iliaca Compartment Block

Blind technique.

Intervention Type PROCEDURE

Femoral Nerve Block

Ultrasound guided.

Intervention Type PROCEDURE

Ropivacaine

Ropivacaine dosed according to local guidelines.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Peripheral nerve block Regional anesthesia Peripheral nerve block Regional anesthesia Local anesthetic Naropin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Linkoeping

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Daniel Wilhelms

MD, Emergency Department Head of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Daniel Wilhelms, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Linköping

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Akutmottagningen US Östergötland

Linköping, Östergötland County, Sweden

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Daniel Leckström, MBBS

Role: CONTACT

+46704555507

Sofia Freland, PhD, MD

Role: CONTACT

+46705868671

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Daniel Wilhelms, PhD

Role: primary

+46101033000

Erika Hörlin, Msc

Role: backup

+46101033041

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SE2021-05967-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.