Spinal versus general anaesthesia and serious complications in older patients undergoing hip fracture surgery in Germany: a multicentre randomised clinical trial.
There appears to be no clinically meaningful difference between spinal and general anaesthesia for older patients undergoing hip fracture surgery, but caution is advised due to the study's limitations.
Where it sits
this study against the rest of the palopegteriparatide corpusSummary and findings
This study evaluated the effects of spinal versus general anaesthesia on all-cause mortality and new-onset serious cardiac and pulmonary complications in patients aged 65 years or older undergoing hip fracture surgery. A total of 771 patients were analyzed, with 385 receiving spinal anaesthesia and 386 receiving general anaesthesia. The primary composite outcome occurred in 14% of the spinal group and 12% of the general group within 30 days post-surgery.
Abstract
<h4>Background</h4>Evidence on the optimal anaesthetic technique for hip fracture surgery is scarce. We evaluated the effects of spinal versus general anaesthesia on all-cause mortality and new-onset serious cardiac and pulmonary complications in older patients undergoing hip fracture surgery.<h4>Methods</h4>We conducted the pragmatic, randomised, two-arm parallel-group, open-label, multicentre Improve Hip Fracture Outcome in the Elderly Patient (iHOPE) trial across 22 German hospitals. Patients aged 65 years or older undergoing hip fracture surgery were randomly assigned (1:1) using a web-based system, stratified by centre, to general anaesthesia (n=389) or spinal anaesthesia (n=386). The primary outcome was time to first occurrence of a composite outcome comprising all-cause mortality and new-onset serious cardiac and pulmonary complications within 30 days post-surgery. The primary analysis followed the intention-to-treat principle and was based on the full analysis set. iHOPE was stopped early, after enrolment of 75% of the target sample size (n=1032), on the recommendation of the data and safety monitoring board, owing to slow recruitment and reduced staffing during the COVID-19 pandemic. iHOPE was registered with the German Clinical Trials Register (DRKS00013644).<h4>Findings</h4>Between April, 2018, and February, 2023, iHOPE enrolled 775 patients. Four patients were excluded before analysis because of erroneous randomisation, withdrawal of consent, death before anaesthesia, or postrandomisation ineligibility, leaving a full analysis set of 771 patients, of whom 528 (69%) were female. The primary endpoint occurred in 55 (14%) of 385 patients in the spinal anaesthesia group and 47 (12%) of 386 patients in the general anaesthesia group. Kaplan-Meier curves showed similar event-free survival in the two groups. The mean (SD) time to first occurrence of the composite outcome was 10·2 (9·7) days in the spinal anaesthesia group and 10·5 (10·4) days in the general anaesthesia group. The primary composite outcome did not differ between the two anaesthetic techniques (centre-stratified hazard ratio: 1·23, 95% CI 0·83-1·82; p=0·29). Adverse events occurred in 320 (83%) of 385 patients in the spinal anaesthesia group and 344 (89%) of 386 patients in the general anaesthesia group, whereas serious adverse events occurred in 109 (34%) of 319 patients in the spinal anaesthesia group and 105 (31%) of 344 patients in the general anaesthesia group. No treatment-related deaths occurred.<h4>Interpretation</h4>Our findings should be interpreted with caution given the premature trial termination, modest statistical power, and high treatment crossover. However, findings add to the evidence supporting an individualised anaesthetic approach, and suggest that there is no clinically meaningful difference between spinal anaesthesia and general anaesthesia for hip fracture surgery.<h4>Funding</h4>German Federal Ministry of Education and Research.
Background
This paper addresses the clinical question of which anaesthetic technique—spinal or general—is optimal for older patients undergoing hip fracture surgery. Prior evidence on this topic is limited, and the choice of anaesthesia can significantly impact patient outcomes. Understanding the implications of different anaesthetic approaches is crucial for improving surgical care in this vulnerable population.
Methods
The study was a pragmatic, randomised, two-arm parallel-group, open-label trial conducted across 22 German hospitals. Patients aged 65 years or older undergoing hip fracture surgery were randomly assigned to either general anaesthesia (n=389) or spinal anaesthesia (n=386). The primary outcome was the time to first occurrence of a composite outcome of all-cause mortality and new-onset serious cardiac and pulmonary complications within 30 days post-surgery.
Results
The primary composite outcome occurred in 55 (14%) of 385 patients in the spinal anaesthesia group and 47 (12%) of 386 patients in the general anaesthesia group. The centre-stratified hazard ratio was 1.23 with a 95% confidence interval of 0.83 to 1.82, and a p-value of 0.29, indicating no statistically significant difference between the two groups.
Interpretation
The findings suggest no clinically meaningful difference between spinal and general anaesthesia for hip fracture surgery, which aligns with some prior studies indicating similar outcomes. However, the modest effect size and lack of statistical significance, combined with the trial's premature termination and high treatment crossover, limit the conclusions that can be drawn. Practitioners should consider these factors when making anaesthetic decisions for older patients.
Key findings
- 14% of patients in the spinal anaesthesia group experienced the primary endpoint compared to 12% in the general anaesthesia group.
- The centre-stratified hazard ratio for the primary composite outcome was 1.23, 95% CI 0.83-1.82; p=0.29.
- Adverse events occurred in 83% of the spinal anaesthesia group and 89% of the general anaesthesia group.
- Serious adverse events occurred in 34% of the spinal anaesthesia group and 31% of the general anaesthesia group.
- The mean time to first occurrence of the composite outcome was 10.2 days for spinal anaesthesia and 10.5 days for general anaesthesia.
Limitations
- Trial stopped early, affecting robustness of findings.
- Modest statistical power due to early termination.
- High treatment crossover may confound results.
- Single-site study may limit generalizability.