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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date June 1, 2016
First Posted Date June 17, 2016
Last Update Posted Date January 11, 2018
Actual Study Start Date August 11, 2016
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 13, 2017)
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
Original Primary Outcome Measures
 (submitted: June 14, 2016)
Total Pre-op IV Morphine Equivalents (TIVME) per 24 hour period [ Time Frame: From Date of admission until date of surgery, approximately 48 hours ]
IV morphine equivalent dosing per 24 hour period
Change History
Current Secondary Outcome Measures
 (submitted: June 17, 2016)
  • Mean Pre-op Pain Score [ Time Frame: From Date of admission until date of surgery, approximately 48 hours ]
    Mean patient-reported pain score
  • Length of Hospital Stay (LOS) [ Time Frame: Through study completion, approximately 5 days ]
Original Secondary Outcome Measures
 (submitted: June 14, 2016)
  • Mean Pre-op Pain Score [ Time Frame: From Date of admission until date of surgery, approximately 48 hours ]
    Mean patient-reported pain score
  • Length of Stay (LOS) [ Time Frame: Through study completion, approximately 5 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Fascia Iliaca Blocks and Pre-operative Opioid Requirements in Hip Fracture Patients
Official Title Pre-operative Fascia Iliaca Blocks and Opioid Requirements in Hip Fracture Patients
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Hip Fracture
Intervention
  • Other: Observational
  • Other: Retrospective review
Study Groups/Cohorts
  • 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.
    Intervention: 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).
    Intervention: Other: Retrospective review
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 14, 2016)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2018
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02804542
Other Study ID Numbers 2016-160
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Spectrum Health Hospitals
Study Sponsor Spectrum Health Hospitals
Collaborators Grand Rapids Medical Education Partners
Investigators
Principal Investigator: Matthew Flannigan, MD ECS
PRS Account Spectrum Health Hospitals
Verification Date January 2018