Fascia Iliaca Blocks and Pre-operative Opioid Requirements in Hip Fracture Patients

September 21, 2023 updated by: Spectrum Health Hospitals

Pre-operative Fascia Iliaca Blocks and Opioid Requirements in Hip Fracture Patients

The purpose of this study is to determine if non-continuous local anesthetic fascia iliaca blocks performed in the emergency department are effective for preoperative analgesia in hip fracture patients. Investigators hypothesize that patients with these blocks will have lower opioid requirements than patients in a historical group in whom blocks were not performed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

29

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients >65 years of age presenting to Spectrum Health Butterworth hospital with low-energy hip fractures (displaced and non-displaced femoral neck, pertrochanteric-type including subtrochanteric extension) will be screened for the study.

Description

Inclusion Criteria:

  • low energy femoral neck and pertrochanteric-type hip fractures
  • age 65+
  • intact cognition upon admission and ability to provide written informed consent

Exclusion Criteria:

  • pathologic fractures (tumor)
  • high energy fractures
  • concomitant fractures besides hip fractures
  • chronic home opioid exposure prior to hospitalization
  • moderate to severe dementia
  • pre-fracture hospitalization
  • time from arrival to block >6 hours
  • time from arrival to OR <6 hours or >48 hours

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fascia Iliaca Block Cohort
Prospective patients receiving fascia iliaca blocks A prospective Observational study of Hip fracture patients that are offered fascia iliaca blocks as standard of care in the ED.
Other: Observational
Retrospective Control Cohort
No fascia iliaca block performed A retrospective review will be done of hip fracture patients that did not receive fascia iliaca blocks (before fascia iliaca blocks being offered in the ED as standard of care).
Other: Retrospective review

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Pre-op IV Morphine Equivalents (TIVME)
Time Frame: From Date of admission until date of surgery, approximately 48 hours
IV morphine equivalent dosing pre-operatively
From Date of admission until date of surgery, approximately 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Pre-op Pain Score
Time Frame: From Date of admission until date of surgery, approximately 48 hours
Mean patient-reported pain score
From Date of admission until date of surgery, approximately 48 hours
Length of Hospital Stay (LOS)
Time Frame: Through study completion, approximately 5 days
Through study completion, approximately 5 days

Collaborators and Investigators

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

Sponsor

Spectrum Health Hospitals

Collaborators

Grand Rapids Medical Education Partners

Investigators

  • Principal Investigator: Matthew Flannigan, MD, ECS

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)

August 11, 2016

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

June 1, 2016

First Submitted That Met QC Criteria

June 14, 2016

First Posted (Estimated)

June 17, 2016

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-160

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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