Impact of Fascia Iliaca Block in Hip Fracture Patients

NCT ID: NCT03525977

Last Updated: 2019-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-20
• Study Completion Date: 2019-05-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Fascia iliaca block

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

Group Type: EXPERIMENTAL

Fascia iliaca block arm

Intervention Type: PROCEDURE

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

Interventions

Fascia iliaca block arm

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

Intervention Type: PROCEDURE

Other Intervention Names

FIB

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Texas Tech University Health Sciences Center, El Paso

OTHER

Sponsor Role: lead

Responsible Party

Mai P. Nguyen

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mai Nguyen, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University Health Sciences Center, El Paso

Locations

University Medical Center

El Paso, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33238043 (View on PubMed)

Other Identifiers

E18046

Identifier Type: -

Identifier Source: org_study_id