Impact of Fascia Iliaca Block in Hip Fracture Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)
• Intervention / Treatment: Procedure: Fascia iliaca block arm

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • El Paso, Texas, United States, 79905
      • University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; Patients in the control arm will receive pain control via traditional oral and intravenous pain medications such as opioids and non-steroidal anti-inflammatory medication as needed.
EXPERIMENTAL: Fascia iliaca block; Patients in the intervention arm will receive the regional fascia iliaca block performed by the anesthesiologists on call.	Procedure: Fascia iliaca block arm; The fascia iliaca block will be performed by the anesthesiologist on call; Other Names: FIB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level	Visual analog scale scores (from 0-10 with 0 being no pain and 10 being the worst pain)	Pre operatively
Pain medication requirement	Morphine equivalent dosing	Pre operatively
Pain level	Visual analog scale scores (from 0-10 with 0 being no pain and 10 being the worst pain)	Four hours after surgery
Pain medication requirement	Morphine equivalent dosing	Four hours after surgery
Pain level	Visual analog scale scores (from 0-10 with 0 being no pain and 10 being the worst pain)	One day after surgery
Pain medication requirement	Morphine equivalent dosing	One day after surgery
Pain level	Visual analog scale scores (from 0-10 with 0 being no pain and 10 being the worst pain)	Two days after surgery
Pain medication requirement	Morphine equivalent dosing	Two days after surgery
Pain level	Visual analog scale scores and morphine equivalent dosing	Three days after surgery
Pain medication requirement	Morphine equivalent dosing	Three days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ambulation distance	Ambulation distance with physical therapy post op	Two days after surgery

Collaborators and Investigators

• Sponsor: Texas Tech University Health Sciences Center, El Paso
• Investigators: Principal Investigator: Mai Nguyen, MD, Texas Tech University Health Sciences Center, El Paso

Publications and helpful links

General Publications

• Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 20, 2018
• Primary Completion (ACTUAL): May 1, 2019
• Study Completion (ACTUAL): May 1, 2019

Study Registration Dates

• First Submitted: May 3, 2018
• First Submitted That Met QC Criteria: May 3, 2018
• First Posted (ACTUAL): May 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 28, 2019
• Last Update Submitted That Met QC Criteria: May 23, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: E18046

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No