NCT02804542

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2016

Typical duration for all trials

Status
completed

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

June 1, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

August 11, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

2.7 years

First QC Date

June 1, 2016

Last Update Submit

September 21, 2023

Conditions

Keywords

fascia iliaca blocks

Outcome Measures

Primary Outcomes (1)

  • Total Pre-op IV Morphine Equivalents (TIVME)

    IV morphine equivalent dosing pre-operatively

    From Date of admission until date of surgery, approximately 48 hours

Secondary Outcomes (2)

  • Mean Pre-op Pain Score

    From Date of admission until date of surgery, approximately 48 hours

  • Length of Hospital Stay (LOS)

    Through study completion, approximately 5 days

Study Arms (2)

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

Interventions

Fascia Iliaca Block Cohort
Retrospective Control Cohort

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hip Fractures

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Matthew Flannigan, MD

    ECS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2016

First Posted

June 17, 2016

Study Start

August 11, 2016

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

September 22, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share