Clinical trial NCT03525977: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)
Lead sponsor: Texas Tech University Health Sciences Center, El Paso
Sponsor class: OTHER
First posted: 2018-05-16
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain level
timeFrame: Pre operatively
measure: Pain medication requirement
timeFrame: Pre operatively
measure: Pain level
timeFrame: Four hours after surgery
measure: Pain medication requirement
timeFrame: Four hours after surgery
measure: Pain level
timeFrame: One day after surgery
measure: Pain medication requirement
timeFrame: One day after surgery
measure: Pain level
timeFrame: Two days after surgery
measure: Pain medication requirement
timeFrame: Two days after surgery
measure: Pain level
timeFrame: Three days after surgery
measure: Pain medication requirement
timeFrame: Three days after surgery
Secondary outcomes:
measure: Ambulation distance
timeFrame: Two days after surgery
Other outcomes:
Locations:
city: El Paso
country: United States
facility: University Medical Center
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center, El Paso
name: Mai Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.