Regional Versus General Anesthesia for Promoting Independence After Hip Fracture

Hip Fractures Clinical Trial

— REGAIN  

Official title:

A Randomized Controlled Trial of Regional Versus General Anesthesia for Promoting Independence After Hip Fracture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02507505
• Other study ID #: 822632
• Secondary ID: PCORI-1406-18876
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: March 2022

Study information

• Verified date: December 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1848
• Est. completion date: March 2022
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	Dalhousie University	Halifax	Nova Scotia
Canada	London Health Sciences Centre	London	Ontario
Canada	Simon Fraser Orthopaedic Fund - Royal Columbian Hospital	New Westminster	British Columbia
Canada	Ottawa Hospital	Ottawa	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario
United States	University Medical Center Brackenridge and Seton Medical Center Williamson	Austin	Texas
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	University of Alabama Birmingham	Birmingham	Alabama
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Maimonides Medical Center	Brooklyn	New York
United States	Lahey Hospital & Medical Center	Burlington	Massachusetts
United States	University of Vermont Medical Center	Burlington	Vermont
United States	Cooper University Hospital	Camden	New Jersey
United States	Northwestern University	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	Englewood Hospital and Medical Center	Englewood	New Jersey
United States	Inova Fairfax Medical Campus	Fairfax	Virginia
United States	University of Florida Gainesville	Gainesville	Florida
United States	Hartford Hospital	Hartford	Connecticut
United States	University of Iowa Hospital & Clinics	Iowa City	Iowa
United States	University of Florida Jacksonville	Jacksonville	Florida
United States	University of Wisconsin-Madison	Madison	Wisconsin
United States	NYU-Winthrop Hospital	Mineola	New York
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Rutgers-Robert Wood Johnson University Hospital	New Brunswick	New Jersey
United States	Yale School of Medicine	New Haven	Connecticut
United States	New York-Presbyterian Hospital/Weill Cornell Medical Center	New York	New York
United States	NYU Langone Medical Center	New York	New York
United States	Christiana Care Health Services	Newark	Delaware
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospitals	Philadelphia	Pennsylvania
United States	Allegheny Health Network	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Reading Hospital	Reading	Pennsylvania
United States	Virginia Commonwealth University Medical Center	Richmond	Virginia
United States	University of California Davis Medical Center	Sacramento	California
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Sacred Heart at RiverBend	Springfield	Oregon
United States	Stony Brook University	Stony Brook	New York
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina
United States	Florida Hospital	Winter Park	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Patient-Centered Outcomes Research Institute

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death or Inability to Walk 10 Feet or Across a Room Without Human Assistance	Will be assessed via telephone interview	Approximately 60 days after Randomization
Secondary	Overall Health and Disability	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.	Approximately 60, 180, and 365 days after randomization
Secondary	Ability to Return to Home	Will be assessed via telephone interview. Measure assessed as death or new transition to nursing home residence at each time point.	Approximately 60, 180, and 365 days after randomization
Secondary	Chronic Pain	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.	Approximately 60, 180, and 365 days after randomization
Secondary	Cognitive Function	Will be assessed via Short Blessed Test (SBT); SBT values range from 0 to 28, with higher scores indicating greater degrees of cognitive impairment.	Baseline and approximately 60, 180, and 365 days after randomization
Secondary	All-cause Mortality	Will be assessed via telephone interview and National Death Index (NDI) search	Approximately 60, 180, and 365 days after randomization
Secondary	Need for Assistive Devices for Walking	Will be assessed via telephone interview	Approximately 60, 180, and 365 days after randomization
Secondary	Acute Postoperative Pain	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.	Before surgery and daily through postoperative day 3 or day of discharge, whichever occurs first
Secondary	Satisfaction With Care	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.	Postoperative day 3 or day of discharge, whichever occurs first
Secondary	Postoperative Delirium	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.	Baseline and daily through postoperative day 3 or day of discharge, whichever occurs first
Secondary	Inpatient Mortality	Will be assessed via medical chart review. Data reported here on inpatient mortality.	During initial hospitalization until day of discharge or 30 days after randomization, whichever occurs first
Secondary	Major Inpatient Morbidity	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.	During initial hospitalization until day of discharge or 30 days after randomization, whichever occurs first