Type of anaesthesia for hip fracture surgery – the problems of trial design

White, Stuart; Griffiths, R.; Moppett, I. K.

doi:10.1111/j.1365-2044.2012.07120.x

Cited by 27 publications

(14 citation statements)

References 46 publications

(63 reference statements)

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“…Contemporaneous calculation and recording within the National Hip Fracture Database dataset of a validated casemix-adjustment score, such as the Nottingham Hip Fracture Score [11], may allow for more refined analysis of mortality by type of anaesthesia in future years. Importantly, the inability of even very large observational studies to detect significant differences in mortality after spinal anaesthesia compared with GA without casemix-adjustment suggests that randomised controlled trials (such have been suggested by NICE [3]) are unlikely to find significant differences in mortality unless they are very large (> 3000 patients per group) and thereforegiven the difficulties inherent in recruiting hip fracture patients to such trialsvery expensive [9], money which might be better spent investigating the effect of type of anaesthesia on other outcomes.…”

Section: Discussionmentioning

confidence: 99%

“…We have previously argued that a randomised controlled trial is not a clinically or financially viable method of comparing outcomes after general or spinal anaesthesia for hip fracture surgery [9], but have advocated the potential for large database observational studies to identify any such differences. The National Hip Fracture Database [7] is one example of just such a database.…”

Section: Introductionmentioning

confidence: 99%

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Outcome by mode of anaesthesia for hip fracture surgery. An observational audit of 65 535 patients in a national dataset

2014

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Summary Large observational studies of accurate data can provide similar results to more arduous and expensive randomised controlled trials. In 2012, the National Hip Fracture Database extended its dataset to include ‘type of anaesthesia’ data fields. We analysed 65 535 patient record sets to determine differences in outcome. Type of anaesthesia was recorded in 59 191 (90%) patients. Omitting patients who received both general and spinal anaesthesia or in whom an uncertain type of anaesthesia was recorded, there was no significant difference in either cumulative five‐day (2.8% vs 2.8%, p = 0.991) or 30‐day (7.0% vs 7.5%, p = 0.053) mortality between 30 130 patients receiving general anaesthesia and 22 999 patients receiving spinal anaesthesia, even when 30‐day mortality was adjusted for age and ASA physical status (p = 0.226). Mortality within 24 hours after surgery was significantly higher among patients receiving cemented compared with uncemented hemiarthroplasty (1.6% vs 1.2%, p = 0.030), suggesting excess early mortality related to bone cement implantation syndrome. If these data are accurate, then either there is no difference in 30‐day mortality between general and spinal anaesthesia after hip fracture surgery per se, and therefore future research should focus on how to make both types of anaesthesia safer, or there is a difference, but mortality is not the correct outcome to measure after anaesthesia, and therefore future research should focus on differences between general and spinal anaesthesia. These could include more anaesthesia‐sensitive outcomes, such as hypotension, pain, postoperative confusion, respiratory infection and mobilisation.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Outcome by mode of anaesthesia for hip fracture surgery. An observational audit of 65 535 patients in a national dataset

2014

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“…This makes randomization of study subjects ethically questionable and, hence, difficult. Most studies published on the subject matter have been retrospective data reviews or observational in nature [17]. The advanced age and the nature and severity of comorbidities most elderly subjects suffer from makes it difficult to quantify any benefits regional anesthesia may offer over general anesthesia in the long run.…”

Section: Discussionmentioning

confidence: 99%

“…Finally, an ethical dilemma that limits the practicality of designing an RCT is the difficulty in recruiting individuals in the study. Since hip fractures are more commonly seen in the elderly, it would be unethical to include patients with cognitive impairments, excluding a significant chunk (25%–45%) of all patients presenting with hip fractures [17]. …”

Section: Discussionmentioning

confidence: 99%

Hip Fracture Surgery: Does Type of Anesthesia Matter?

Rashid

Shah

Shakoor

et al. 2013

BioMed Research International

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Background. Hip fracture surgery is a common procedure, and the geriatric population with its multiple comorbid conditions is at most at risk of developing anesthesia-related complications. Data on the impact of type anesthesia on postoperative morbidity and mortality is limited. The effects of regional and general anesthesia on postoperative outcomes need to be clearly elucidated. Methods. In this study, all patients who underwent dynamic hip screw (DHS) fixation for intertrochanteric fractures, between January 2005 and December 2010, at the Aga Khan University Hospital, were included. Patients were divided into two groups; group A included those patients who received general anesthesia, and group B consisted of patients who had received regional anesthesia. The two groups were compared for differences in morbidity, mortality, and intraoperative complications based on the type of anesthesia administered. Results. During this period, 194 patients underwent DHS fixation. One hundred and seven patients received general anesthesia whereas eighty-seven patients received regional anesthesia. The mean operative time was significantly lower in the group receiving regional anesthesia (1.25 ± 0.39 hrs) as compared to those who received general anesthesia (1.54 ± 0.6 hrs) (P < 0.05). There were no statistically significant differences in the rates of wound infections, length of hospital stay, postoperative ambulation status, intraoperative blood loss, postoperative complications, and mortality between the regional and general anesthesia groups. Conclusion. Even though administration of regional anesthesia was positively correlated with shorter operative duration, the type of anesthesia was not found to affect surgical outcomes in the two study groups. Based on these results, we recommend that anesthesia should be tailored to individual patient requirements.

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“…It occurs 30 days after the intervention and so will be affected by any number of other factors that are unrelated to anaesthesia [4]. Other recent large U.S. retrospective observational studies of general surgical patients have found significant associations between intra-operative hypotension (MAP <55 mmHg) and increased risk of cerebrovascular accident [5], acute kidney injury and myocardial injury [6, 7], suggesting a plausible causative link between anaesthesia-induced hypotension and early post-operative ‘ischaemic’ complications.…”

Section: Introductionmentioning

confidence: 99%

Tight intra-operative blood pressure control versus standard care for patients undergoing hip fracture repair – Hip Fracture Intervention Study for Prevention of Hypotension (HIP-HOP) trial: study protocol for a randomised controlled trial

Moppett

White

Griffiths

et al. 2017

Trials

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BackgroundHypotension during anaesthesia for hip fracture surgery is common. Recent data suggest that there is an association between the lowest intra-operative blood pressure and mortality, even when adjusted for co-morbidities. This is consistent with data derived from the wider surgical population, where magnitude and duration of hypotension are associated with mortality and peri-operative complications. However, there are no trial to data to support more aggressive blood pressure control.Methods/designWe are conducting a three-centre, randomised, double-blinded pilot study in three hospitals in the United Kingdom. The sample size will be 75 patients (25 from each centre). Randomisation will be done using computer-generated concealed tables. Both participants and investigators will be blinded to group allocation. Participants will be aged >70 years, cognitively intact (Abbreviated Mental Test Score 7 or greater), able to give informed consent and admitted directly through the emergency department with a fractured neck of the femur requiring operative repair. Patients randomised to tight blood pressure control or avoidance of intra-operative hypotension will receive active treatment as required to maintain both of the following: systolic arterial blood pressure >80% of baseline pre-operative value and mean arterial pressure >75 mmHg throughout. All participants will receive standard hospital care, including spinal or general anaesthesia, at the discretion of the clinical team. The primary outcome is a composite of the presence or absence of defined cardiovascular, renal and delirium morbidity within 7 days of surgery (myocardial injury, stroke, acute kidney injury, delirium). Secondary endpoints will include the defined individual morbidities, mortality, early mobility and discharge to usual residence.DiscussionThis is a small-scale pilot study investigating the feasibility of a trial of tight intra-operative blood pressure control in a frail elderly patient group with known high morbidity and mortality. Positive findings will provide the basis for a larger-scale study.Trial registrationISRCTN Registry identifier: ISRCTN89812075. Registered on 30 August 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2066-5) contains supplementary material, which is available to authorized users.

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Type of anaesthesia for hip fracture surgery – the problems of trial design

Cited by 27 publications

References 46 publications

Outcome by mode of anaesthesia for hip fracture surgery. An observational audit of 65 535 patients in a national dataset

Outcome by mode of anaesthesia for hip fracture surgery. An observational audit of 65 535 patients in a national dataset

Hip Fracture Surgery: Does Type of Anesthesia Matter?

Tight intra-operative blood pressure control versus standard care for patients undergoing hip fracture repair – Hip Fracture Intervention Study for Prevention of Hypotension (HIP-HOP) trial: study protocol for a randomised controlled trial

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