TY - JOUR
T1 - Spinal anesthesia or general anesthesia for hip surgery in older adults
AU - Neuman, Mark D.
AU - Feng, Rui
AU - Carson, Jeffrey L.
AU - Gaskins, Lakisha J.
AU - Dillane, Derek
AU - Sessler, Daniel I.
AU - Sieber, Frederick
AU - Magaziner, Jay
AU - Marcantonio, Edward R.
AU - Mehta, Samir
AU - Menio, Diane
AU - Ayad, Sabry
AU - Stone, Trevor
AU - Papp, Steven
AU - Schwenk, Eric S.
AU - Elkassabany, Nabil
AU - Marshall, Mitchell
AU - Jaffe, J. Douglas
AU - Luke, Charles
AU - Sharma, Balram
AU - Azim, Syed
AU - Hymes, Robert A.
AU - Chin, Ki Jinn
AU - Sheppard, Richard
AU - Perlman, Barry
AU - Sappenfield, Joshua
AU - Hauck, Ellen
AU - Hoeft, Mark A.
AU - Giska, Mark
AU - Ranganath, Yatish
AU - Tedore, Tiffany
AU - Choi, Stephen
AU - Li, Jinlei
AU - Kwofie, M. Kwesi
AU - Nader, Antoun
AU - Sanders, Robert D.
AU - Allen, Brian F.S.
AU - Vlassakov, Kamen
AU - Kates, Stephen
AU - Fleisher, Lee A.
AU - Dattilo, James
AU - Tierney, Ann
AU - Stephens-Shields, Alisa J.
AU - Ellenberg, Susan S.
N1 - Funding Information:
We conducted the Regional versus General Anesthesia for Promoting Independence after Hip Fracture (REGAIN) trial, a multicenter, pragmatic, randomized superiority trial funded by the Patient-Centered Outcomes Research Institute. The trial design has been described previously.10 The trial was investigator-initiated and was planned and conducted with the participation of patients and stakeholder organizations (the Center for Advocacy for the Rights and Interests of the Elderly and the Gerontological Society of America).11 There was no commercial participation in the trial. The institutional review board of the University of Pennsylvania, the institution that oversaw the conduct of the trial, approved the protocol (available with the full text of this article at NEJM.org) and was the institutional review board of record for 11 sites; approval at other sites was obtained through local institutional review boards.12 Written informed consent was obtained
Publisher Copyright:
Copyright © 2021 Massachusetts Medical Society.
PY - 2021/11/25
Y1 - 2021/11/25
N2 - BACKGROUND The effects of spinal anesthesia as compared with general anesthesia on the ability to walk in older adults undergoing surgery for hip fracture have not been well studied. METHODS We conducted a pragmatic, randomized superiority trial to evaluate spinal anesthesia as compared with general anesthesia in previously ambulatory patients 50 years of age or older who were undergoing surgery for hip fracture at 46 U.S. and Canadian hospitals. Patients were randomly assigned in a 1:1 ratio to receive spinal or general anesthesia. The primary outcome was a composite of death or an inability to walk approximately 10 ft (3 m) independently or with a walker or cane at 60 days after randomization. Secondary outcomes included death within 60 days, delirium, time to discharge, and ambulation at 60 days. RESULTS A total of 1600 patients were enrolled; 795 were assigned to receive spinal anesthesia and 805 to receive general anesthesia. The mean age was 78 years, and 67.0% of the patients were women. A total of 666 patients (83.8%) assigned to spinal anesthesia and 769 patients (95.5%) assigned to general anesthesia received their assigned anesthesia. Among patients in the modified intention-to-treat population for whom data were available, the composite primary outcome occurred in 132 of 712 patients (18.5%) in the spinal anesthesia group and 132 of 733 (18.0%) in the general anesthesia group (relative risk, 1.03; 95% confidence interval [CI], 0.84 to 1.27; P=0.83). An inability to walk independently at 60 days was reported in 104 of 684 patients (15.2%) and 101 of 702 patients (14.4%), respectively (relative risk, 1.06; 95% CI, 0.82 to 1.36), and death within 60 days occurred in 30 of 768 (3.9%) and 32 of 784 (4.1%), respectively (relative risk, 0.97; 95% CI, 0.59 to 1.57). Delirium occurred in 130 of 633 patients (20.5%) in the spinal anesthesia group and in 124 of 629 (19.7%) in the general anesthesia group (relative risk, 1.04; 95% CI, 0.84 to 1.30). CONCLUSIONS Spinal anesthesia for hip-fracture surgery in older adults was not superior to general anesthesia with respect to survival and recovery of ambulation at 60 days. The incidence of postoperative delirium was similar with the two types of anesthesia.
AB - BACKGROUND The effects of spinal anesthesia as compared with general anesthesia on the ability to walk in older adults undergoing surgery for hip fracture have not been well studied. METHODS We conducted a pragmatic, randomized superiority trial to evaluate spinal anesthesia as compared with general anesthesia in previously ambulatory patients 50 years of age or older who were undergoing surgery for hip fracture at 46 U.S. and Canadian hospitals. Patients were randomly assigned in a 1:1 ratio to receive spinal or general anesthesia. The primary outcome was a composite of death or an inability to walk approximately 10 ft (3 m) independently or with a walker or cane at 60 days after randomization. Secondary outcomes included death within 60 days, delirium, time to discharge, and ambulation at 60 days. RESULTS A total of 1600 patients were enrolled; 795 were assigned to receive spinal anesthesia and 805 to receive general anesthesia. The mean age was 78 years, and 67.0% of the patients were women. A total of 666 patients (83.8%) assigned to spinal anesthesia and 769 patients (95.5%) assigned to general anesthesia received their assigned anesthesia. Among patients in the modified intention-to-treat population for whom data were available, the composite primary outcome occurred in 132 of 712 patients (18.5%) in the spinal anesthesia group and 132 of 733 (18.0%) in the general anesthesia group (relative risk, 1.03; 95% confidence interval [CI], 0.84 to 1.27; P=0.83). An inability to walk independently at 60 days was reported in 104 of 684 patients (15.2%) and 101 of 702 patients (14.4%), respectively (relative risk, 1.06; 95% CI, 0.82 to 1.36), and death within 60 days occurred in 30 of 768 (3.9%) and 32 of 784 (4.1%), respectively (relative risk, 0.97; 95% CI, 0.59 to 1.57). Delirium occurred in 130 of 633 patients (20.5%) in the spinal anesthesia group and in 124 of 629 (19.7%) in the general anesthesia group (relative risk, 1.04; 95% CI, 0.84 to 1.30). CONCLUSIONS Spinal anesthesia for hip-fracture surgery in older adults was not superior to general anesthesia with respect to survival and recovery of ambulation at 60 days. The incidence of postoperative delirium was similar with the two types of anesthesia.
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U2 - 10.1056/NEJMoa2113514
DO - 10.1056/NEJMoa2113514
M3 - Article
C2 - 34623788
AN - SCOPUS:85120411139
SN - 0028-4793
VL - 385
SP - 2025
EP - 2035
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 22
ER -