Regional Versus General Anesthesia for Promoting Independence After Hip Fracture

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hip Fractures

Intervention / Treatment
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* Procedure: Regional Anesthesia
* Procedure: General Anesthesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Regional Anesthesia<br>Approximately half of the subjects will be randomized to the arm which receives Regional Anesthesia. | Procedure: Regional Anesthesia<br>* 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.<br>* Other names: Regional Block or Spinal Block;|
| Active Comparator: General Anesthesia<br>Approximately half of the subjects will be randomized to the arm which receives General Anesthesia. | Procedure: General Anesthesia<br>* 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.<br>* Other names: General Endotracheal Anesthesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall health and disability | Will be assessed via the World Health Organization Disability Assessment Schedule (WHODAS) | Approximately 60, 180, and 365 days after randomization | 
| Ability to return to home | Will be assessed via telephone interview | Approximately 60, 180, and 365 days after randomization | 
| Chronic Pain | Will be assessed via the Numeric Rating Scale (NRS) and the need for prescription medications as evaluated during telephone interview | Approximately 60, 180, and 365 days after randomization | 
| Cognitive Function | Will be assessed via Short Blessed Test | Baseline and approximately 60, 180, and 365 days after randomization | 
| All-cause mortality | Will be assessed via telephone interview and National Death Index (NDI) search | Approximately 60, 180, and 365 days after randomization | 
| Cause of death | Will be assessed via NDI search | One year after randomization | 
| Need for assistive devices for walking | Will be assessed via telephone interview | Approximately 60, 180, and 365 days after randomization | 
| Acute postoperative pain | Will be assessed via in-person interview | Before surgery and daily through postoperative day 3 or day of discharge, whichever occurs first | 
| Satisfaction with care | Will be assessed via Bauer Patient Satisfaction Questionnaire | Postoperative day 3 or day of discharge, whichever occurs first | 
| Postoperative delirium | Will be assessed via 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) assessment tool | Baseline and daily through postoperative day 3 or day of discharge, whichever occurs first | 
| Inpatient mortality and major inpatient morbidity | Will be assessed via medical chart review | During initial hospitalization until day of discharge or 30 days after randomization, whichever occurs first |