Project Summary

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final. In the meantime, results have been published in peer-reviewed journals, as listed below.

PCORI has identified the need for large studies that look at real-life questions faced by diverse patients, caregivers, and clinicians. To address this need, PCORI launched the Pragmatic Clinical Studies initiative in 2014. Pragmatic clinical studies allow for larger-scale studies with longer timelines to compare the benefits and harms of two or more approaches known to be effective for preventing, diagnosing, treating, or managing a disease or symptom. They focus on everyday care for a wide range of patients. This research project is one of the studies PCORI awarded as part of this program.

What is the research about?

Each year, more than 300,000 adults in the United States break a hip. Nine out of 10 hip fractures occur in people age 50 or older. Hip fractures can cause serious problems. After a fracture, half of people who lived on their own previously either die within a year or move to a nursing home. Many adults who could walk without help, need help to walk 10 feet after a fracture.

Nearly all people with a hip fracture need surgery, and they need anesthesia during surgery. Anesthesia uses medicines that block pain or make people sleep. The two most common types of anesthesia for hip fracture surgery are general anesthesia and spinal anesthesia. With general anesthesia, doctors make patients sleep during surgery by giving them medicine through an IV or mask. With spinal anesthesia, doctors give patients a shot of medicine in the spine to numb the legs and lower abdomen. People who get spinal anesthesia usually also get medicine to make them sleep so that they’re comfortable during surgery.

Previous research suggests that using spinal anesthesia during hip fracture surgery may help patients get better faster and with less pain than general anesthesia. But research findings are unclear and outdated. This study compares how these two types of anesthesia during hip fracture surgery affect patients’ recovery and long-term health. The research team wants to learn if the two types of anesthesia have the same results or if one is better for people having hip fracture surgery.

Who can this research help?

This study can help adults age 50 and older undergoing hip fracture surgery and their doctors choose a type of anesthesia.

What is the research team doing?

The research team is working with 45 university and community hospitals in the United States and Canada. The team is enrolling 1,600 patients aged 50 and older who are scheduled to have surgery for a hip fracture. They must have been able to walk across a room without help before the fracture. The research team is assigning people by chance to get either spinal anesthesia or general anesthesia during surgery.

Research staff members are contacting patients by phone two months after surgery. They are asking patients if they can walk at least 10 feet across a room without help. Researchers are also asking patients about their overall health, pain, memory, concentration, ability to walk, and ability to live on their own.

The research team designed the study with a patient advocacy group, medical professional societies, and a patient and caregiver advisory group. Patient advisors are meeting regularly with the research team to receive study updates and to give input on activities, findings, and sharing results.

Research methods at a glance

Design Element Description
Study Design Randomized controlled trial
Population Adults aged 50 and older who are having hip fracture surgery, are eligible for spinal and general anesthesia, and could walk 10 feet without help before the fracture
Interventions/
Comparators
  • Spinal anesthesia
  • General anesthesia
Outcomes

Primary: ability to walk

Secondary: overall health and disability, ability to live at home independently, self-reported pain rating, memory and concentration

Timeframe Timeframe Length of follow-up for collecting data on primary outcomes. View Glossary 60-day follow-up for primary outcome

Engagement Resources

Journal Citations

Article Highlight: Each year, more than 300,000 adults in the United States break a hip and nearly all will need surgery. This study, which compared how general anesthesia and spinal anesthesia during hip fracture surgery affected recovery, found patients who received spinal anesthesia received fewer opioids in the operating room but had more pain and prescription pain medication use after surgery. These results were published in the Annals of Internal Medicine. Overall, patients with spinal anesthesia had slightly higher levels of pain (7.9 out of 10) compared to those who had general anesthesia (7.6). Further results showed spinal anesthesia patients were also 33 percent more likely than general anesthesia patients to still be taking prescription painkillers roughly two months out from their procedure.

Project Information

Mark D. Neuman, MD, MS
University of Pennsylvania
$11,824,195
A Practical Intervention to Improve Patient-Centered Outcomes after Hip Fractures among Older Adults (Regain Trial)

Key Dates

April 2015
November 2023
2015

Study Registration Information

Tags

Has Results
Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: November 30, 2022