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

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ClinicalTrials.gov Identifier: NCT02804542
Recruitment Status : Unknown
Verified January 2018 by Spectrum Health Hospitals.
Recruitment status was:  Enrolling by invitation
First Posted : June 17, 2016
Last Update Posted : January 11, 2018
Sponsor:
Collaborator:
Grand Rapids Medical Education Partners
Information provided by (Responsible Party):
Spectrum Health Hospitals

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.

Condition or disease Intervention/treatment
Hip Fracture Other: Observational Other: Retrospective review

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Pre-operative Fascia Iliaca Blocks and Opioid Requirements in Hip Fracture Patients
Actual Study Start Date : August 11, 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Mean Pre-op Pain Score [ Time Frame: From Date of admission until date of surgery, approximately 48 hours ]
    Mean patient-reported pain score

  2. Length of Hospital Stay (LOS) [ Time Frame: Through study completion, approximately 5 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804542


Sponsors and Collaborators
Spectrum Health Hospitals
Grand Rapids Medical Education Partners
Investigators
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Principal Investigator: Matthew Flannigan, MD ECS
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Responsible Party: Spectrum Health Hospitals
ClinicalTrials.gov Identifier: NCT02804542    
Other Study ID Numbers: 2016-160
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Spectrum Health Hospitals:
fascia iliaca blocks
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries