Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Multicenter Study
. 2016 Nov 15;6(11):e013473.
doi: 10.1136/bmjopen-2016-013473.

Regional versus General Anesthesia for Promoting Independence after Hip Fracture (REGAIN): protocol for a pragmatic, international multicentre trial

Mark D Neuman  1   2   3   4 , Susan S Ellenberg  5 , Frederick E Sieber  6 , Jay S Magaziner  7 , Rui Feng  5 , Jeffrey L Carson  8 ; REGAIN Investigators
Collaborators, Affiliations
Multicenter Study

Regional versus General Anesthesia for Promoting Independence after Hip Fracture (REGAIN): protocol for a pragmatic, international multicentre trial

Mark D Neuman et al. BMJ Open. .

Abstract

Introduction: Hip fractures occur 1.6 million times each year worldwide, with substantial associated mortality and losses of independence. At present, anaesthesia care for hip fracture surgery varies widely within and between countries, with general anaesthesia and spinal anaesthesia representing the 2 most common approaches. Limited randomised evidence exists regarding potential short-term or long-term differences in outcomes between patients receiving spinal or general anaesthesia for hip fracture surgery.

Methods: The REGAIN trial (Regional vs General Anesthesia for Promoting Independence after Hip Fracture) is an international, multicentre, pragmatic randomised controlled trial. 1600 previously ambulatory patients aged 50 and older will be randomly allocated to receive either general or spinal anaesthesia for hip fracture surgery. The primary outcome is a composite of death or new inability to walk 10 feet or across a room at 60 days after randomisation, which will be assessed via telephone interview by staff who are blinded to treatment assignment. Secondary outcomes will be assessed by in-person assessment and medical record review for in-hospital end points (delirium; major inpatient medical complications and mortality; acute postoperative pain; patient satisfaction; length of stay) and by telephone interview for 60-day, 180-day and 365-day end points (mortality; disability-free survival; chronic pain; return to the prefracture residence; need for new assistive devices for ambulation; cognitive impairment).

Ethics and dissemination: The REGAIN trial has been approved by the ethics boards of all participating sites. Recruitment began in February 2016 and will continue until the end of 2019. Dissemination plans include presentations at scientific conferences, scientific publications, stakeholder engagement efforts and presentation to the public via lay media outlets.

Trial registration number: NCT02507505, Pre-results.

Keywords: ANAESTHETICS; GERIATRIC MEDICINE.

PubMed Disclaimer

Conflict of interest statement

MDN, SSE and RF report grants from PCORI, during the conduct of the study. MDN reports grants from National Institutes of Health, outside the submitted work. JSM, JLC and FES report grants from University of Pennsylvania subcontract as study investigator, during the conduct of the study. JSM reports personal fees from Novartis, personal fees from Scholar Rock, personal fees from Ammonett LLC, personal fees from Viking, personal fees from Sanofi, outside the submitted work.

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Brauer CA, Coca-Perraillon M, Cutler DM et al. . Incidence and mortality of hip fractures in the United States. JAMA 2009;302:1573–9. 10.1001/jama.2009.1462 - DOI - PMC - PubMed
    1. Blackman DK, Kamimoto LA, Smith SM. Overview: surveillance for selected public health indicators affecting older adults—United States. MMWR CDC Surveill Summ 1999;48:1–6. - PubMed
    1. Haentjens P, Autier P, Barette M et al. . Survival and functional outcome according to hip fracture type: a one-year prospective cohort study in elderly women with an intertrochanteric or femoral neck fracture. Bone 2007;41:958–64. 10.1016/j.bone.2007.08.026 - DOI - PubMed
    1. Leslie WD, O'Donnell S, Jean S et al. . Trends in hip fracture rates in Canada. JAMA 2009;302:883–9. 10.1001/jama.2009.1231 - DOI - PubMed
    1. Tajeu GS, Delzell E, Smith W et al. . Death, debility, and destitution following hip fracture. J Gerontol A Biol Sci Med Sci 2014;69:346–53. 10.1093/gerona/glt105 - DOI - PMC - PubMed

Publication types

Associated data