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

May 3, 2022 updated by: Daniel Wilhelms, University Hospital, Linkoeping

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Block
Blind technique.
Other Names:
  • Regional anesthesia
  • Peripheral nerve block
Drug: Ropivacaine
Ropivacaine dosed according to local guidelines.
Other Names:
  • Naropin
  • Local anesthetic
Femoral Nerve Block (FNB)
Participants with a radiologically verified hip fracture receiving a FNB using ultrasound guidance for direct nerve visualisation.
Drug: Ropivacaine
Ropivacaine dosed according to local guidelines.
Other Names:
  • Naropin
  • Local anesthetic
Procedure: Femoral Nerve Block
Ultrasound guided.
Other Names:
  • Regional anesthesia
  • Peripheral nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Measured 30 minutes after administered nerve block.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ratio of Failed Blocks
Time Frame: Through study completion, an average of 1 year
Defined by a failure to reduce reported pain 30 minutes after administered block by at least one whole unit on the numeric rating scale
Through study completion, an average of 1 year
Rate of Complications
Time Frame: Through study completion, an average of 1 year
Comparing the rate of any reported complication between cohorts
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Linkoeping

Investigators

  • Principal Investigator: Daniel Wilhelms, PhD, MD, University Hospital, Linköping

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

April 27, 2022

First Submitted That Met QC Criteria

May 3, 2022

First Posted (Actual)

May 9, 2022

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SE2021-05967-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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