Regional Versus General Anesthesia for Promoting Independence After Hip Fracture
- Conditions
- Hip Fractures
- Interventions
- Procedure: Regional AnesthesiaProcedure: General Anesthesia
- Registration Number
- NCT02507505
- Lead Sponsor
- University of Pennsylvania
- Brief Summary
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.
- 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.
Approximately 2,424 subjects will be enrolled (i.e. informed consent for participation will be obtained) in order to yield approximately 1,600 randomized patients. This estimate is based on an assumption that one in three patients (33%) who undergo consent prior to surgery will not be randomized on the day of surgery due to active clinical issues, timing of medication dosing, clinical assessments by treating physicians or the site Clinical Director or their designate, or patient withdrawal of consent.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1848
- 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
- Planned concurrent surgery not amenable to spinal anesthesia
- Absolute contraindications to spinal anesthesia
- Periprosthetic fracture
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Regional Anesthesia Regional Anesthesia Approximately half of the subjects will be randomized to the arm which receives Regional Anesthesia. General Anesthesia General Anesthesia Approximately half of the subjects will be randomized to the arm which receives General Anesthesia.
- Primary Outcome Measures
Name Time Method Death or Inability to Walk 10 Feet or Across a Room Without Human Assistance Approximately 60 days after Randomization Will be assessed via telephone interview
- Secondary Outcome Measures
Name Time Method Chronic Pain Approximately 60, 180, and 365 days after randomization Will be assessed via the Numeric Rating Scale (NRS) and the need for prescription medications as evaluated during telephone interview. NRS values range from 0 to 10, with higher values indicating greater pain.
Cognitive Function Baseline and approximately 60, 180, and 365 days after randomization Will be assessed via Short Blessed Test (SBT); SBT values range from 0 to 28, with higher scores indicating greater degrees of cognitive impairment.
Need for Assistive Devices for Walking Approximately 60, 180, and 365 days after randomization Will be assessed via telephone interview
Postoperative Delirium Baseline and daily through postoperative day 3 or day of discharge, whichever occurs first Will be assessed via 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) assessment tool. Any positive 3D-CAM screen over the first 3 postoperative days in a patient with a negative pre-randomization screen was counted as a case of incident delirium.
Inpatient Mortality During initial hospitalization until day of discharge or 30 days after randomization, whichever occurs first Will be assessed via medical chart review. Data reported here on inpatient mortality.
Major Inpatient Morbidity During initial hospitalization until day of discharge or 30 days after randomization, whichever occurs first Indicates occurrence of any of 12 complications based on medical record review: Myocardial infarction; Nonfatal cardiac arrest; Stroke; Pneumonia; Pulmonary edema; Pulmonary embolism; Unplanned postoperative intubation; Surgical-site infection; Urinary tract infection; Any return to the operating room; Critical care admission; Acute kidney injury.
Overall Health and Disability Approximately 60, 180, and 365 days after randomization Will be assessed via the 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). The 12-item WHODAS 2.0 scale measures disability in six functional domains (cognition, mobility, self-care, social interaction, life activities, and community participation). Scores range from 0 to 100, with lower scores indicating lower degrees of disability.
Ability to Return to Home Approximately 60, 180, and 365 days after randomization Will be assessed via telephone interview. Measure assessed as death or new transition to nursing home residence at each time point.
All-cause Mortality Approximately 60, 180, and 365 days after randomization Will be assessed via telephone interview and National Death Index (NDI) search
Satisfaction With Care Postoperative day 3 or day of discharge, whichever occurs first Will be assessed via Bauer Patient Satisfaction Questionnaire. Data reported here corresponds to a response of "dissatisfied" or "very dissatisfied" to one or more of 5 Bauer questionnaire items assessing the following domains: information given by anesthesiologist before surgery; waking up from anesthesia; pain therapy after surgery; treatment of nausea and vomiting after surgery; care provided by department of anesthesia in general.
Acute Postoperative Pain Before surgery and daily through postoperative day 3 or day of discharge, whichever occurs first Will be assessed via in-person interview using numeric rating scale (NRS). NRS values range from 0 to 10, with greater values indicating worse pain.
Trial Locations
- Locations (45)
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
University of Iowa Hospital & Clinics
🇺🇸Iowa City, Iowa, United States
Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
University of Florida Jacksonville
🇺🇸Jacksonville, Florida, United States
Johns Hopkins Bayview Medical Center
🇺🇸Baltimore, Maryland, United States
Florida Hospital
🇺🇸Winter Park, Florida, United States
Allegheny Health Network
🇺🇸Pittsburgh, Pennsylvania, United States
NYU Langone Medical Center
🇺🇸New York, New York, United States
New York-Presbyterian Hospital/Weill Cornell Medical Center
🇺🇸New York, New York, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
Thomas Jefferson University Hospitals
🇺🇸Philadelphia, Pennsylvania, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Penn Presbyterian Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Sacred Heart at RiverBend
🇺🇸Springfield, Oregon, United States
Inova Fairfax Medical Campus
🇺🇸Fairfax, Virginia, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
University Medical Center Brackenridge and Seton Medical Center Williamson
🇺🇸Austin, Texas, United States
Simon Fraser Orthopaedic Fund - Royal Columbian Hospital
🇨🇦New Westminster, British Columbia, Canada
University of Alberta
🇨🇦Edmonton, Alberta, Canada
University of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
Dalhousie University
🇨🇦Halifax, Nova Scotia, Canada
NYU-Winthrop Hospital
🇺🇸Mineola, New York, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Rutgers-Robert Wood Johnson University Hospital
🇺🇸New Brunswick, New Jersey, United States
Englewood Hospital and Medical Center
🇺🇸Englewood, New Jersey, United States
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Lahey Hospital & Medical Center
🇺🇸Burlington, Massachusetts, United States
Maimonides Medical Center
🇺🇸Brooklyn, New York, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
Virginia Commonwealth University Medical Center
🇺🇸Richmond, Virginia, United States
University of Florida Gainesville
🇺🇸Gainesville, Florida, United States
Stony Brook University
🇺🇸Stony Brook, New York, United States
Reading Hospital
🇺🇸Reading, Pennsylvania, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
Yale School of Medicine
🇺🇸New Haven, Connecticut, United States
Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
University of Wisconsin-Madison
🇺🇸Madison, Wisconsin, United States