Purpose

The purpose of this study is to find out if two types of standard care anesthesia are the same or if one is better for people who have hip fractures.

Condition

Eligibility

Eligible Ages
Over 50 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Clinically or radiographically diagnosed intracapsular or extracapsular hip fracture
  • Planned surgical treatment via hemiarthroplasty, total hip arthroplasty or appropriate fixation procedure
  • Ability to walk 10 feet or across a room without human assistance before fracture

Exclusion Criteria

  • Planned concurrent surgery not amenable to spinal anesthesia
  • Absolute contraindications to spinal anesthesia
  • Periprosthetic fracture

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Regional Anesthesia
Approximately half of the subjects will be randomized to the arm which receives Regional Anesthesia.
  • Procedure: Regional Anesthesia
    Regional anesthesia involves temporarily numbing parts of the body with nerve blocks. Spinal anesthesia is a type of regional anesthesia that uses medications injected into the fluid surrounding the spinal cord to temporarily numb the legs and lower abdomen. Spinal anesthesia is the most widely used type of regional anesthesia for hip fracture surgery. While intravenous sedation is typically used for comfort with spinal anesthesia, invasive airway interventions are not typically required.
    Other names:
    • Regional Block or Spinal Block
Active Comparator
General Anesthesia
Approximately half of the subjects will be randomized to the arm which receives General Anesthesia.
  • Procedure: General Anesthesia
    General anesthesia uses injected or inhaled medications to keep people unconscious during surgery. Since general anesthesia depresses breathing and impairs protective airway reflexes, invasive airway interventions such as breathing tube placement and mechanical ventilation are usually required.
    Other names:
    • General Endotracheal Anesthesia

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37212
Contact:
Valerie Lineberry, RN, CCRP

More Details

Status
Recruiting
Sponsor
University of Pennsylvania

Study Contact

Lakisha Gaskins, MHS
(215) 746-6094
regain@lists.upenn.edu

Detailed Description

Hip fracture is a clinical condition that involves a break in the femur (hip bone) near where it attaches to the pelvis. Hip fractures occur more than 300,000 times each year in the US and over 1.6 million times each year worldwide.

Over 90% of hip fractures occur in individuals aged 50 or older, most commonly resulting from low-energy traumatic injuries, such as falls from standing in the context of established osteoporosis, chronic illness, or disability. Surgical treatment, via fixation of the fractured bone or partial or total replacement of the hip joint, is indicated for all types of hip fractures and approximately 95% of hip fracture patients undergo surgery.

No evidence-based interventions now exist to improve functional outcomes after hip fracture surgery beyond the immediate postoperative period. Nearly all hip fracture patients require orthopedic surgery and anesthesia,making the anesthetic care episode a major opportunity to impact outcomes.

Spinal and general anesthesia represent the two standard care approaches to anesthesia for hip fracture surgery. Basic and clinical research has identified multiple plausible mechanisms by which spinal anesthesia may improve outcomes after hip fracture; nonetheless, major guidelines and systematic reviews have identified key evidence gaps and anesthesia care for hip fracture varies markedly in practice. While spinal and general anesthesia for hip fracture have been previously compared in retrospective studies and small randomized trials, much of the available prospective trial data is old and may not be reflective of current clinical practice.

REGAIN will be the first pragmatic multicenter prospective randomized trial of spinal versus general anesthesia for hip fracture surgery designed to evaluate the association of anesthesia technique with functional recovery after hip fracture. As such, it will fill critical evidence gaps to inform policy and practice.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.