Regional Versus General Anesthesia for Promoting Independence After Hip Fracture (REGAIN)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02507505|
Recruitment Status : Active, not recruiting
First Posted : July 24, 2015
Last Update Posted : April 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hip Fractures||Procedure: Regional Anesthesia Procedure: General Anesthesia||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1848 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Controlled Trial of Regional Versus General Anesthesia for Promoting Independence After Hip Fracture|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
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 Name: 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 Name: General Endotracheal Anesthesia
- Death or inability to walk 10 feet or across a room without human assistance [ Time Frame: Approximately 60 days after Randomization ]Will be assessed via telephone interview
- Overall health and disability [ Time Frame: Approximately 60, 180, and 365 days after randomization ]Will be assessed via the World Health Organization Disability Assessment Schedule (WHODAS)
- Ability to return to home [ Time Frame: Approximately 60, 180, and 365 days after randomization ]Will be assessed via telephone interview
- Chronic Pain [ Time Frame: 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
- Cognitive Function [ Time Frame: Baseline and approximately 60, 180, and 365 days after randomization ]Will be assessed via Short Blessed Test
- All-cause mortality [ Time Frame: Approximately 60, 180, and 365 days after randomization ]Will be assessed via telephone interview and National Death Index (NDI) search
- Cause of death [ Time Frame: One year after randomization ]Will be assessed via NDI search
- Need for assistive devices for walking [ Time Frame: Approximately 60, 180, and 365 days after randomization ]Will be assessed via telephone interview
- Acute postoperative pain [ Time Frame: Before surgery and daily through postoperative day 3 or day of discharge, whichever occurs first ]Will be assessed via in-person interview
- Satisfaction with care [ Time Frame: Postoperative day 3 or day of discharge, whichever occurs first ]Will be assessed via Bauer Patient Satisfaction Questionnaire
- Postoperative delirium [ Time Frame: 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
- Inpatient mortality and major inpatient morbidity [ Time Frame: During initial hospitalization until day of discharge or 30 days after randomization, whichever occurs first ]Will be assessed via medical chart review
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02507505
|Principal Investigator:||Mark D Neuman, MD, MSc||University of Pennsylvania|