NCT03525977

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 16, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

May 28, 2019

Status Verified

May 1, 2019

Enrollment Period

1.2 years

First QC Date

May 3, 2018

Last Update Submit

May 23, 2019

Conditions

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

Outcome Measures

Primary Outcomes (10)

  • 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 Outcomes (1)

  • Ambulation distance

    Two days after surgery

Study Arms (2)

Control

NO INTERVENTION

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.

Fascia iliaca block

EXPERIMENTAL

Patients in the intervention arm will receive the regional fascia iliaca block performed by the anesthesiologists on call.

Procedure: Fascia iliaca block arm

Interventions

Fascia iliaca block armPROCEDURE

The fascia iliaca block will be performed by the anesthesiologist on call

Also known as: FIB
Fascia iliaca block

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with femoral neck and intertrochanteric hip fractures
  • At least 18 years of age
  • Require operative management

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center

El Paso, Texas, 79905, United States

Location

Related Publications (1)

  • 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.

    PMID: 33238043DERIVED

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Mai Nguyen, MD

    Texas Tech University Health Sciences Center, El Paso

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 3, 2018

First Posted

May 16, 2018

Study Start

February 20, 2018

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

May 28, 2019

Record last verified: 2019-05

Locations

US(1)