Impact of Fascia Iliaca Block in Hip Fracture Patients
Primary Purpose
Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fascia iliaca block arm
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)
Eligibility 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.
Sites / Locations
- University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Fascia iliaca block
Arm Description
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.
Patients in the intervention arm will receive the regional fascia iliaca block performed by the anesthesiologists on call.
Outcomes
Primary Outcome Measures
Pain level
Visual analog scale scores (from 0-10 with 0 being no pain and 10 being the worst pain)
Pain medication requirement
Morphine equivalent dosing
Pain level
Visual analog scale scores (from 0-10 with 0 being no pain and 10 being the worst pain)
Pain medication requirement
Morphine equivalent dosing
Pain level
Visual analog scale scores (from 0-10 with 0 being no pain and 10 being the worst pain)
Pain medication requirement
Morphine equivalent dosing
Pain level
Visual analog scale scores (from 0-10 with 0 being no pain and 10 being the worst pain)
Pain medication requirement
Morphine equivalent dosing
Pain level
Visual analog scale scores and morphine equivalent dosing
Pain medication requirement
Morphine equivalent dosing
Secondary Outcome Measures
Ambulation distance
Ambulation distance with physical therapy post op
Full Information
NCT ID
NCT03525977
First Posted
May 3, 2018
Last Updated
May 23, 2019
Sponsor
Texas Tech University Health Sciences Center, El Paso
1. Study Identification
Unique Protocol Identification Number
NCT03525977
Brief Title
Impact of Fascia Iliaca Block in Hip Fracture Patients
Official Title
Impact of Fascia Iliaca Block on Pain Outcomes and Opioid Consumption for Hip Fracture Patients-A Prospective, Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
February 20, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Tech University Health Sciences Center, El Paso
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Fascia iliaca block
Arm Type
Experimental
Arm Description
Patients in the intervention arm will receive the regional fascia iliaca block performed by the anesthesiologists on call.
Intervention Type
Procedure
Intervention Name(s)
Fascia iliaca block arm
Other Intervention Name(s)
FIB
Intervention Description
The fascia iliaca block will be performed by the anesthesiologist on call
Primary Outcome Measure Information:
Title
Pain level
Description
Visual analog scale scores (from 0-10 with 0 being no pain and 10 being the worst pain)
Time Frame
Pre operatively
Title
Pain medication requirement
Description
Morphine equivalent dosing
Time Frame
Pre operatively
Title
Pain level
Description
Visual analog scale scores (from 0-10 with 0 being no pain and 10 being the worst pain)
Time Frame
Four hours after surgery
Title
Pain medication requirement
Description
Morphine equivalent dosing
Time Frame
Four hours after surgery
Title
Pain level
Description
Visual analog scale scores (from 0-10 with 0 being no pain and 10 being the worst pain)
Time Frame
One day after surgery
Title
Pain medication requirement
Description
Morphine equivalent dosing
Time Frame
One day after surgery
Title
Pain level
Description
Visual analog scale scores (from 0-10 with 0 being no pain and 10 being the worst pain)
Time Frame
Two days after surgery
Title
Pain medication requirement
Description
Morphine equivalent dosing
Time Frame
Two days after surgery
Title
Pain level
Description
Visual analog scale scores and morphine equivalent dosing
Time Frame
Three days after surgery
Title
Pain medication requirement
Description
Morphine equivalent dosing
Time Frame
Three days after surgery
Secondary Outcome Measure Information:
Title
Ambulation distance
Description
Ambulation distance with physical therapy post op
Time Frame
Two days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mai Nguyen, MD
Organizational Affiliation
Texas Tech University Health Sciences Center, El Paso
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33238043
Citation
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.
Results Reference
derived
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Impact of Fascia Iliaca Block in Hip Fracture Patients
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