Regional versus General Anesthesia for Promoting Independence after Hip Fracture (REGAIN): protocol for a pragmatic, international multicentre trial. Issue 11 (15th November 2016)

• Record Type: Journal Article
• Authors: Neuman, Mark D; Ellenberg, Susan S; Sieber, Frederick E; Magaziner, Jay S; Feng, Rui; Carson, Jeffrey L
• Other Names: author non-byline.; Fleisher Lee A author non-byline.; Orwig Denise author non-byline.; Mehta Samir author non-byline.; Marcantonio Edward author non-byline.; Elkassabany Nabil author non-byline.; Schwartz J Sanford author non-byline.; Kates Steven L author non-byline.; Gaskins Lakisha author non-byline.; Montgomery Brittany author non-byline.; Spangler Elaine author non-byline.; Cifelli Denise author non-byline.; Helker Christopher author non-byline.; Doe Ro-Pauline author non-byline.; Williams Nyra author non-byline.; Datillo Jim author non-byline.; Tierney Ann author non-byline.; Vlassakov Kamen author non-byline.; Gavin Lauren author non-byline.; Sessler Daniel author non-byline.; Esr Wael Ali Sakr author non-byline.; Ayad Sabry author non-byline.; Hassan Manal author non-byline.; Cipolle Mark author non-byline.; Shander Aryeh author non-byline.; Lobel Gregg author non-byline.; Looke Thomas author non-byline.; Lewis Courtland author non-byline.; Sheppard Richard author non-byline.; Alsaden Mohamed Rida author non-byline.; Ouanes Jean-Pierre author non-byline.; Hymes Robert author non-byline.; Sanders David author non-byline.; Hannenberg Alexander author non-byline.; Nader Antoun author non-byline.; Tedore Tiffany author non-byline.; Marshall Mitchell author non-byline.; Papp Steven author non-byline.; Donegan Derek author non-byline.; Adhikary Sanjib author non-byline.; Troxell Karen author non-byline.; Kiss Geza author non-byline.; Perlman Barry author non-byline.; Choi Stephen author non-byline.; Azim Syed author non-byline.; Gonzalez Meera author non-byline.; Haydel Christopher author non-byline.; Chin Ki Jinn author non-byline.; Sappenfield Joshua author non-byline.; Warrick Matthew author non-byline.; Powell Mark author non-byline.; Dillane Derek author non-byline.; Waters Jonathan author non-byline.; Dominick Timothy author non-byline.; Dabiri A Jared author non-byline.; Weigel Wade author non-byline.; Jaffe J Douglas author non-byline.; Akhatar Shamsuddin author non-byline.; O'Neill Greg author non-byline.; D'Antonio Patricia author non-byline.; Menio Diane author non-byline.; Hruslinski Jennifer author non-byline.; Diamond Sandy author non-byline.; Ferrick Catherine author non-byline.; Hunt James author non-byline.; Langlois Christine author non-byline.; Nurick Donna author non-byline.; Soffer Bernice author non-byline.; Stojak Linda author non-byline.; Sokoloff Eleanor author non-byline.;
• Is Part Of: BMJ open. Volume 6:Issue 11(2016)
• Publication Date: 2016-11-15
• Subjects: ANAESTHETICS -- GERIATRIC MEDICINE; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2016-013473
• Languages: English
• ISSNs: 2044-6055

Abstract

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.