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

Mark D Neuman, Susan S Ellenberg, Frederick E Sieber, Jay S Magaziner, Rui Feng, Jeffrey L Carson, REGAIN Investigators, Lee A Fleisher, Denise Orwig, Samir Mehta, Edward Marcantonio, Nabil Elkassabany, J Sanford Schwartz, Steven L Kates, Lakisha Gaskins, Brittany Montgomery, Elaine Spangler, Denise Cifelli, Christopher Helker, Ro-Pauline Doe, Nyra Williams, Jim Datillo, Ann Tierney, Kamen Vlassakov, Lauren Gavin, Daniel Sessler, Wael Ali Sakr Esr, Sabry Ayad, Manal Hassan, Mark Cipolle, Aryeh Shander, Gregg Lobel, Thomas Looke, Courtland Lewis, Richard Sheppard, Mohamed Rida Alsaden, Jean-Pierre Ouanes, Robert Hymes, David Sanders, Alexander Hannenberg, Antoun Nader, Tiffany Tedore, Mitchell Marshall, Steven Papp, Derek Donegan, Sanjib Adhikary, Karen Troxell, Geza Kiss, Barry Perlman, Stephen Choi, Syed Azim, Meera Gonzalez, Christopher Haydel, Ki Jinn Chin, Joshua Sappenfield, Matthew Warrick, Mark Powell, Derek Dillane, Jonathan Waters, Timothy Dominick, A Jared Dabiri, Wade Weigel, J Douglas Jaffe, Shamsuddin Akhatar, Greg O'Neill, Patricia D'Antonio, Diane Menio, Jennifer Hruslinski, Sandy Diamond, Catherine Ferrick, James Hunt, Christine Langlois, Donna Nurick, Bernice Soffer, Linda Stojak, Eleanor Sokoloff, Mark D Neuman, Susan S Ellenberg, Frederick E Sieber, Jay S Magaziner, Rui Feng, Jeffrey L Carson, REGAIN Investigators, Lee A Fleisher, Denise Orwig, Samir Mehta, Edward Marcantonio, Nabil Elkassabany, J Sanford Schwartz, Steven L Kates, Lakisha Gaskins, Brittany Montgomery, Elaine Spangler, Denise Cifelli, Christopher Helker, Ro-Pauline Doe, Nyra Williams, Jim Datillo, Ann Tierney, Kamen Vlassakov, Lauren Gavin, Daniel Sessler, Wael Ali Sakr Esr, Sabry Ayad, Manal Hassan, Mark Cipolle, Aryeh Shander, Gregg Lobel, Thomas Looke, Courtland Lewis, Richard Sheppard, Mohamed Rida Alsaden, Jean-Pierre Ouanes, Robert Hymes, David Sanders, Alexander Hannenberg, Antoun Nader, Tiffany Tedore, Mitchell Marshall, Steven Papp, Derek Donegan, Sanjib Adhikary, Karen Troxell, Geza Kiss, Barry Perlman, Stephen Choi, Syed Azim, Meera Gonzalez, Christopher Haydel, Ki Jinn Chin, Joshua Sappenfield, Matthew Warrick, Mark Powell, Derek Dillane, Jonathan Waters, Timothy Dominick, A Jared Dabiri, Wade Weigel, J Douglas Jaffe, Shamsuddin Akhatar, Greg O'Neill, Patricia D'Antonio, Diane Menio, Jennifer Hruslinski, Sandy Diamond, Catherine Ferrick, James Hunt, Christine Langlois, Donna Nurick, Bernice Soffer, Linda Stojak, Eleanor Sokoloff

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.

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.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

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