In older adults undergoing surgical repair for hip fracture, does regional anesthesia reduce the incidence of postoperative delirium compared with general anesthesia?
In this randomized clinical trial that included 950 older adults, the incidence of postoperative delirium in regional anesthesia without sedation was 6.2% vs 5.1% with use of general anesthesia, a difference that was not statistically significant.
Regional anesthesia compared with general anesthesia did not significantly reduce the incidence and severity of postoperative delirium in older adults undergoing fragility hip fracture repair.
In adults undergoing hip fracture surgery, regional anesthesia may reduce postoperative delirium, but there is uncertainty about its effectiveness.
To investigate, in older adults undergoing surgical repair for hip fracture, the effects of regional anesthesia on the incidence of postoperative delirium compared with general anesthesia.
Design, Setting, and Participants
A randomized, allocation-concealed, open-label, multicenter clinical trial of 950 patients, aged 65 years and older, with or without preexisting dementia, and a fragility hip fracture requiring surgical repair from 9 university teaching hospitals in Southeastern China. Participants were enrolled between October 2014 and September 2018; 30-day follow-up ended November 2018.
Patients were randomized to receive either regional anesthesia (spinal, epidural, or both techniques combined with no sedation; n = 476) or general anesthesia (intravenous, inhalational, or combined anesthetic agents; n = 474).
Main Outcomes and Measures
Primary outcome was incidence of delirium during the first 7 postoperative days. Secondary outcomes analyzed in this article include delirium severity, duration, and subtype; postoperative pain score; length of hospitalization; 30-day all-cause mortality; and complications.
Among 950 randomized patients (mean age, 76.5 years; 247 [26.8%] male), 941 were evaluable for the primary outcome (6 canceled surgery and 3 withdrew consent). Postoperative delirium occurred in 29 (6.2%) in the regional anesthesia group vs 24 (5.1%) in the general anesthesia group (unadjusted risk difference [RD], 1.1%; 95% CI, –1.7% to 3.8%; P = .48; unadjusted relative risk [RR], 1.2 [95% CI, 0.7 to 2.0]; P = .57]). Mean severity score of delirium was 23.0 vs 24.1, respectively (unadjusted difference, –1.1; 95% CI, –4.6 to 3.1). A single delirium episode occurred in 16 (3.4%) vs 10 (2.1%) (unadjusted RD, 1.1%; 95% CI, –1.7% to 3.9%; RR, 1.6 [95% CI, 0.7 to 3.5]). Hypoactive subtype in 11 (37.9%) vs 5 (20.8%) (RD, 11.5; 95% CI, –11.0% to 35.7%; RR, 2.2 [95% CI, 0.8 to 6.3]). Median worst pain score was 0 (IQR, 0 to 20) vs 0 (IQR, 0 to 10) (difference 0; 95% CI, 0 to 0). Median length of hospitalization was 7 days (IQR, 5 to 10) vs 7 days (IQR, 6 to 10) (difference 0; 95% CI, 0 to 0). Death occurred in 8 (1.7%) vs 4 (0.9%) (unadjusted RD, –0.8%; 95% CI, –2.2% to 0.7%; RR, 2.0 [95% CI, 0.6 to 6.5]). Adverse events were reported in 106 episodes in the regional anesthesia group and 102 in the general anesthesia group; the most frequently reported adverse events were nausea and vomiting (47 [44.3%] vs 34 [33.3%]) and postoperative hypotension (13 [12.3%] vs 10 [9.8%]).
Conclusions and Relevance
In patients aged 65 years and older undergoing hip fracture surgery, regional anesthesia without sedation did not significantly reduce the incidence of postoperative delirium compared with general anesthesia.
ClinicalTrials.gov Identifier: NCT02213380
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Corresponding Authors: Fang Gao Smith, PhD, Birmingham Acute Care Research Center, Institute of Inflammation and Ageing, Birmingham University Research Labs, Edgbaston, University of Birmingham, Birmingham B15 2WB, United Kingdom (firstname.lastname@example.org); Qingquan Lian, PhD, Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, 1111 Wenzhou Avenue, Longwan District, Wenzhou 325038, Zhejiang, China (email@example.com).
Accepted for Publication: December 1, 2021.
Published Online: December 20, 2021. doi:10.1001/jama.2021.22647
Correction: This article was corrected on March 22, 2022, to fix numeric values in Table 2, Table 3, and in eTable 4 in the online supplement.
Author Contributions: Drs Ting Li and Smith had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: T. Li, J. Li, Daniels, Yeung, Jin, Smith, Lian.
Acquisition, analysis, or interpretation of data: T. Li, J. Li, Yuan, Jinze Wu, Jiang, Daniels, Mehta, Wang, Jackson, Melody, Yao, Jimin Wu, Chen, Smith, Lian.
Drafting of the manuscript: T. Li, J. Li, Jinze Wu, Jiang, Daniels, Mehta, Jin, Yao, Jimin Wu, Smith, Lian.
Critical revision of the manuscript for important intellectual content: Yuan, Jiang, Daniels, Mehta, Wang, Yeung, Jackson, Melody, Chen, Smith, Lian.
Statistical analysis: Jiang, Mehta, Smith.
Obtained funding: T. Li, J. Li, Jin, Smith, Lian.
Administrative, technical, or material support: T. Li, Yuan, Jinze Wu, Wang, Melody, Yao, Jimin Wu, Chen, Smith, Lian.
Supervision: J. Li, Daniels, Mehta, Yeung, Smith, Lian.
Conflict of Interest Disclosures: Dr Daniels reports receipt of a grant from the National Institutes for Health Research (NIHR). Mr Mehta reports receipt of a grant from the NIHR. Dr Yeung reports receipt of a grant from the NIHR. Dr Jackson reports receipt of grants from the NIHR, UK Research Innovation (UKRI) and the Medical Research Council (MRC) UK. Mrs Melody reports receipt of a grant from the NIHR. Dr Jin reports receipt of the Zhejiang Science and Technology Award and a grant from the National Natural Science Foundation of China. Dr Smith reports receipt of grants from the NIHR, UKRI, the MRC UK, and the National Natural Science Foundation of China; and the NIHR Senior Investigator Personal Award. No other disclosures were reported.
Funding/Support: This trial was funded by Recruitment Program of Global Experts, China; Zhejiang Province Basic Public Welfare Research Project (LGF21H250004); Zhejiang Health and Family Planning Commission Programme (2014PYA015); an NIHR Senior Investigator Award; the Health Commission of Zhejiang Province; Zhejiang Provincial Department of Science and Technology; and sponsored by the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University.
Role of the Funder/Sponsor: The funders and sponsor had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Group Information: A full list of members of Trial Management Group, Trial Steering Committee, Data Monitoring and Ethics Committee, and participating sites are provided in eAppendices 2, 3, and 4 in Supplement 3 and in Supplement 4.
Data Sharing Statement: See Supplement 5.
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