Impact of Fascia Iliaca Block in Hip Fracture Patients

Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures) Clinical Trial

Official title:

Impact of Fascia Iliaca Block on Pain Outcomes and Opioid Consumption for Hip Fracture Patients-A Prospective, Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03525977
• Other study ID #: E18046
• Status: Completed
• Phase: N/A
• Start date: February 20, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: May 2019
• Source: Texas Tech University Health Sciences Center, El Paso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is a prospective randomized examining the impact of fascia iliaca block on perioperative pain control and post operative ambulation in patients with hip fractures.

Description:

Regional anesthesia is an important element of multimodal pain control regimen for surgical patients. Recently, regional anesthesia using a fascia iliaca block (FIB) to help treat pain in patients who present with hip fractures has been gaining popularity and has been incorporated as part of a multi-modal pain control protocol in many centers. It is commonly offered in addition to oral and intravenous medications to help patients deal with pain in the perioperative period. The block is done by an anesthesiologist under anesthesia using ultrasound guidance. We propose a prospective, randomized study evaluating the efficacy of the FIB as an adjunct in the pre-operative or postoperative period for pain control as measured by visual analog scale (VAS) scores and morphine equivalent dosing (MED), as well as its efficacy in promoting patient participation in physical therapy postoperatively in patients who present with hip fractures. We hypothesize that those patients who receive FIBs will report lower VAS scores as well as decreased narcotic requirement at all time points; and have improved participation in therapy when measured by ambulation distance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients with femoral neck and intertrochanteric hip fractures

• At least 18 years of age

• Require operative management

Exclusion Criteria:

• Poly-trauma patients

• Pathologic fractures

• Patient who required revision procedures

• Patients with chronic opioid use

• Patients with a clinical status that precludes verbal pain assessment such as dementia, head injuries, and unwillingness to participate.

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)

Intervention

Procedure:
• Fascia iliaca block arm
The fascia iliaca block will be performed by the anesthesiologist on call

Locations

Country	Name	City	State
United States	University Medical Center	El Paso	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center, El Paso

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain level	Visual analog scale scores (from 0-10 with 0 being no pain and 10 being the worst pain)	Pre operatively
Primary	Pain medication requirement	Morphine equivalent dosing	Pre operatively
Primary	Pain level	Visual analog scale scores (from 0-10 with 0 being no pain and 10 being the worst pain)	Four hours after surgery
Primary	Pain medication requirement	Morphine equivalent dosing	Four hours after surgery
Primary	Pain level	Visual analog scale scores (from 0-10 with 0 being no pain and 10 being the worst pain)	One day after surgery
Primary	Pain medication requirement	Morphine equivalent dosing	One day after surgery
Primary	Pain level	Visual analog scale scores (from 0-10 with 0 being no pain and 10 being the worst pain)	Two days after surgery
Primary	Pain medication requirement	Morphine equivalent dosing	Two days after surgery
Primary	Pain level	Visual analog scale scores and morphine equivalent dosing	Three days after surgery
Primary	Pain medication requirement	Morphine equivalent dosing	Three days after surgery
Secondary	Ambulation distance	Ambulation distance with physical therapy post op	Two days after surgery