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BMJ Open. 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.

Author information

1
Department of Anesthesiology and Critical Care, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
2
Leonard Davis Institute for Health Economics, The University of Pennsylvania, Philadelphia, Pennsylvania, USA.
3
Department of Internal Medicine, Division of Geriatric Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
4
Center for Perioperative Outcomes Research and Transformation (CPORT), University of Pennsylvania, Philadelphia, Pennsylvania, USA.
5
Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
6
Department of Anesthesiology, Johns Hopkins Bayview Medical Center, Baltimore, Maryland, USA.
7
Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.
8
Department of Medicine, Division of General Internal Medicine, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA.

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

PMID:
27852723
PMCID:
PMC5129073
DOI:
10.1136/bmjopen-2016-013473
[Indexed for MEDLINE]
Free PMC Article

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.

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