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REGAIN: Regional Versus General Anesthesia for Promoting Independence After Hip Fracture

Sponsor
University of Pennsylvania (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02507505
Collaborator
Patient-Centered Outcomes Research Institute (Other)
1,848
Enrollment
45
Locations
2
Arms
82
Duration (Months)
41.1
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Regional Anesthesia
  • Procedure: General Anesthesia
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1848 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Randomized Controlled Trial of Regional Versus General Anesthesia for Promoting Independence After Hip Fracture
Study Start Date :
Feb 1, 2016
Actual Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Overall health and disability [Approximately 60, 180, and 365 days after randomization]

      Will be assessed via the World Health Organization Disability Assessment Schedule (WHODAS)

    2. Ability to return to home [Approximately 60, 180, and 365 days after randomization]

      Will be assessed via telephone interview

    3. 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

    4. Cognitive Function [Baseline and approximately 60, 180, and 365 days after randomization]

      Will be assessed via Short Blessed Test

    5. All-cause mortality [Approximately 60, 180, and 365 days after randomization]

      Will be assessed via telephone interview and National Death Index (NDI) search

    6. Cause of death [One year after randomization]

      Will be assessed via NDI search

    7. Need for assistive devices for walking [Approximately 60, 180, and 365 days after randomization]

      Will be assessed via telephone interview

    8. 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

    9. Satisfaction with care [Postoperative day 3 or day of discharge, whichever occurs first]

      Will be assessed via Bauer Patient Satisfaction Questionnaire

    10. 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

    11. Inpatient mortality and major inpatient morbidity [During initial hospitalization until day of discharge or 30 days after randomization, whichever occurs first]

      Will be assessed via medical chart review

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama Birmingham Birmingham Alabama United States 35249
    2 University of California Davis Medical Center Sacramento California United States 95817
    3 Hartford Hospital Hartford Connecticut United States 06102
    4 Yale School of Medicine New Haven Connecticut United States 06520
    5 Christiana Care Health Services Newark Delaware United States 19718
    6 University of Florida Gainesville Gainesville Florida United States 32608
    7 University of Florida Jacksonville Jacksonville Florida United States 32209
    8 Florida Hospital Winter Park Florida United States 32792
    9 Northwestern University Chicago Illinois United States 60611
    10 University of Iowa Hospital & Clinics Iowa City Iowa United States 52242
    11 Johns Hopkins Bayview Medical Center Baltimore Maryland United States 21224
    12 Brigham & Women's Hospital Boston Massachusetts United States 02115
    13 Lahey Hospital & Medical Center Burlington Massachusetts United States 01805
    14 Henry Ford Hospital Detroit Michigan United States 48202
    15 Cooper University Hospital Camden New Jersey United States 08103
    16 Englewood Hospital and Medical Center Englewood New Jersey United States 07631
    17 Rutgers-Robert Wood Johnson University Hospital New Brunswick New Jersey United States 08901
    18 Maimonides Medical Center Brooklyn New York United States 11219
    19 NYU-Winthrop Hospital Mineola New York United States 11501
    20 NYU Langone Medical Center New York New York United States 10003
    21 New York-Presbyterian Hospital/Weill Cornell Medical Center New York New York United States 10065
    22 Stony Brook University Stony Brook New York United States 11794
    23 Wake Forest University Baptist Medical Center Winston-Salem North Carolina United States 27157
    24 Cleveland Clinic Cleveland Ohio United States 44195
    25 Sacred Heart at RiverBend Springfield Oregon United States 97477
    26 Penn Presbyterian Medical Center Philadelphia Pennsylvania United States 19104
    27 Thomas Jefferson University Hospitals Philadelphia Pennsylvania United States 19107
    28 Temple University Hospital Philadelphia Pennsylvania United States 19140
    29 Allegheny Health Network Pittsburgh Pennsylvania United States 15212
    30 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15232
    31 Reading Hospital Reading Pennsylvania United States 19611
    32 Vanderbilt University Medical Center Nashville Tennessee United States 37212
    33 University Medical Center Brackenridge and Seton Medical Center Williamson Austin Texas United States 78705
    34 University of Vermont Medical Center Burlington Vermont United States 05401
    35 Inova Fairfax Medical Campus Fairfax Virginia United States 22042
    36 Virginia Commonwealth University Medical Center Richmond Virginia United States 23298
    37 Virginia Mason Medical Center Seattle Washington United States 98101
    38 University of Wisconsin-Madison Madison Wisconsin United States 53792
    39 University of Alberta Edmonton Alberta Canada T6G 2B7
    40 Simon Fraser Orthopaedic Fund - Royal Columbian Hospital New Westminster British Columbia Canada V3L 3M2
    41 Dalhousie University Halifax Nova Scotia Canada B3H 1V7
    42 London Health Sciences Centre London Ontario Canada N6A 5W9
    43 Ottawa Hospital Ottawa Ontario Canada K1Y 4E9
    44 Sunnybrook Health Sciences Centre Toronto Ontario Canada
    45 Toronto Western Hospital Toronto Ontario Canada

    Sponsors and Collaborators

    • University of Pennsylvania
    • Patient-Centered Outcomes Research Institute

    Investigators

    • Principal Investigator: Mark D Neuman, MD, MSc, University of Pennsylvania

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT02507505
    Other Study ID Numbers:
    • 822632
    • PCORI-1406-18876
    First Posted:
    Jul 24, 2015
    Last Update Posted:
    Jan 11, 2022
    Last Verified:
    Jan 1, 2022
    Additional relevant MeSH terms:
    Fractures, Bone
    Hip Fractures
    Anesthetics

    Study Results

    No Results Posted as of Jan 11, 2022