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Completed

NCT Number: NCT03525977

Impact of Fascia Iliaca Block in Hip Fracture Patients

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center

El Paso, Texas, 79905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fascia iliaca block arm

Procedure

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

Other names: FIB

Primary outcomes

  1. Pain level

    Time frame: Pre operatively

    Visual analog scale scores (from 0-10 with 0 being no pain and 10 being the worst pain)

  2. Pain medication requirement

    Time frame: Pre operatively

    Morphine equivalent dosing

  3. Pain level

    Time frame: Four hours after surgery

    Visual analog scale scores (from 0-10 with 0 being no pain and 10 being the worst pain)

  4. Pain medication requirement

    Time frame: Four hours after surgery

    Morphine equivalent dosing

  5. Pain level

    Time frame: One day after surgery

    Visual analog scale scores (from 0-10 with 0 being no pain and 10 being the worst pain)

  6. Pain medication requirement

    Time frame: One day after surgery

    Morphine equivalent dosing

  7. Pain level

    Time frame: Two days after surgery

    Visual analog scale scores (from 0-10 with 0 being no pain and 10 being the worst pain)

  8. Pain medication requirement

    Time frame: Two days after surgery

    Morphine equivalent dosing

  9. Pain level

    Time frame: Three days after surgery

    Visual analog scale scores and morphine equivalent dosing

  10. Pain medication requirement

    Time frame: Three days after surgery

    Morphine equivalent dosing

Secondary outcomes

  1. Ambulation distance

    Time frame: Two days after surgery

    Ambulation distance with physical therapy post op

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center, El Paso

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 16, 2018
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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