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

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

Study Description

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

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Sponsors and Collaborators

Spectrum Health Hospitals

Grand Rapids Medical Education Partners

Investigators

• Principal Investigator: Matthew Flannigan, MD; ECS

More Information

• Responsible Party: Spectrum Health Hospitals
• ClinicalTrials.gov Identifier: NCT02804542
• Other Study ID Numbers: 2016-160
• First Posted: June 17, 2016
• 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:

Fractures, Bone; Hip Fractures; Wounds and Injuries; Femoral Fractures; Hip Injuries; Leg Injuries