ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 14 of 127 for:    Recruiting, Not yet recruiting, Available Studies | "Hip Injuries"

Impact of Fascia Iliaca Block in Hip Fracture Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03525977
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Mai P. Nguyen, Texas Tech University Health Sciences Center, El Paso

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.

Condition or disease Intervention/treatment Phase
Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures) Procedure: Fascia iliaca block arm Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Fascia Iliaca Block on Pain Outcomes and Opioid Consumption for Hip Fracture Patients-A Prospective, Randomized Study
Actual Study Start Date : February 20, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine


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 Name: FIB




Primary Outcome Measures :
  1. Pain control [ Time Frame: 4h, 24 h and 72 h post op ]
    Visual analog scale scores and morphine equivalent dosing


Secondary Outcome Measures :
  1. Ambulation distance [ Time Frame: 24 h, 48 h and 72 h post op ]
    Ambulation distance with physical therapy post op



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03525977


Contacts
Contact: Mai Nguyen, MD 915-215-5480 mai.p.nguyen@ttuhsc.edu
Contact: Michael Reich, MD 915-215-5480 Michael.s.reich@ttuhsc.edu

Locations
United States, Texas
University Medical Center Recruiting
El Paso, Texas, United States, 79905
Contact: Mai Nguyen, MD    915-215-5480    mai.p.nguyen@ttuhsc.edu   
Principal Investigator: Mai Nguyen, MD         
Sponsors and Collaborators
Texas Tech University Health Sciences Center, El Paso
Investigators
Principal Investigator: Mai Nguyen, MD Texas Tech University Health Sciences Center, El Paso

Responsible Party: Mai P. Nguyen, Assistant Professor, Texas Tech University Health Sciences Center, El Paso
ClinicalTrials.gov Identifier: NCT03525977     History of Changes
Other Study ID Numbers: E18046
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries