Regional Versus General Anesthesia for Promoting Independence After Hip Fracture

NCT ID: NCT02507505

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1848 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2022-03-31

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.

Conditions

Hip Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Regional Anesthesia

Approximately half of the subjects will be randomized to the arm which receives Regional Anesthesia.

Group Type: ACTIVE_COMPARATOR

Regional Anesthesia

Intervention Type: PROCEDURE

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

Approximately half of the subjects will be randomized to the arm which receives General Anesthesia.

Group Type: ACTIVE_COMPARATOR

General Anesthesia

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Regional Block or Spinal Block; General Endotracheal Anesthesia

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark D Neuman, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Alabama Birmingham

Birmingham, Alabama, United States

University of California Davis Medical Center

Sacramento, California, United States

Hartford Hospital

Hartford, Connecticut, United States

Yale School of Medicine

New Haven, Connecticut, United States

Christiana Care Health Services

Newark, Delaware, United States

University of Florida Gainesville

Gainesville, Florida, United States

University of Florida Jacksonville

Jacksonville, Florida, United States

Florida Hospital

Winter Park, Florida, United States

Northwestern University

Chicago, Illinois, United States

University of Iowa Hospital & Clinics

Iowa City, Iowa, United States

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

Lahey Hospital & Medical Center

Burlington, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Cooper University Hospital

Camden, New Jersey, United States

Englewood Hospital and Medical Center

Englewood, New Jersey, United States

Rutgers-Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Maimonides Medical Center

Brooklyn, New York, United States

NYU-Winthrop Hospital

Mineola, New York, 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

Stony Brook University

Stony Brook, New York, United States

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Sacred Heart at RiverBend

Springfield, Oregon, United States

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospitals

Philadelphia, Pennsylvania, United States

Temple University Hospital

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

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University Medical Center Brackenridge and Seton Medical Center Williamson

Austin, Texas, United States

University of Vermont Medical Center

Burlington, Vermont, United States

Inova Fairfax Medical Campus

Fairfax, Virginia, United States

Virginia Commonwealth University Medical Center

Richmond, Virginia, United States

Virginia Mason Medical Center

Seattle, Washington, United States

University of Wisconsin-Madison

Madison, Wisconsin, United States

University of Alberta

Edmonton, Alberta, Canada

Simon Fraser Orthopaedic Fund - Royal Columbian Hospital

New Westminster, British Columbia, Canada

Dalhousie University

Halifax, Nova Scotia, Canada

London Health Sciences Centre

London, Ontario, Canada

Ottawa Hospital

Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Toronto Western Hospital

Toronto, Ontario, Canada

Countries

United States; Canada

References

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Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PCORI-1406-18876

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

822632

Identifier Type: -

Identifier Source: org_study_id