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Improve hip fracture outcome in the elderly patient (iHOPE): a study protocol for a pragmatic, multicentre randomised controlled trial to test the efficacy of spinal versus general anaesthesia.

ABSTRACT: INTRODUCTION:Hip fracture surgery is associated with high in-hospital and 30-day mortality rates and serious adverse patient outcomes. Evidence from randomised controlled trials regarding effectiveness of spinal versus general anaesthesia on patient-centred outcomes after hip fracture surgery is sparse. METHODS AND ANALYSIS:The iHOPE study is a pragmatic national, multicentre, randomised controlled, open-label clinical trial with a two-arm parallel group design. In total, 1032 patients with hip fracture (>65 years) will be randomised in an intended 1:1 allocation ratio to receive spinal anaesthesia (n=516) or general anaesthesia (n=516). Outcome assessment will occur in a blinded manner after hospital discharge and inhospital. The primary endpoint will be assessed by telephone interview and comprises the time to the first occurring event of the binary composite outcome of all-cause mortality or new-onset serious cardiac and pulmonary complications within 30 postoperative days. In-hospital secondary endpoints, assessed via in-person interviews and medical record review, include mortality, perioperative adverse events, delirium, satisfaction, walking independently, length of hospital stay and discharge destination. Telephone interviews will be performed for long-term endpoints (all-cause mortality, independence in walking, chronic pain, ability to return home cognitive function and overall health and disability) at postoperative day 30±3, 180±45?and 365±60. ETHICS AND DISSEMINATION: iHOPE has been approved by the leading Ethics Committee of the Medical Faculty of the RWTH Aachen University on 14 March 2018 (EK 022/18). Approval from all other involved local Ethical Committees was subsequently requested and obtained. Study started in April 2018 with a total recruitment period of 24 months. iHOPE will be disseminated via presentations at national and international scientific meetings or conferences and publication in peer-reviewed international scientific journals. TRIAL REGISTRATION NUMBER:DRKS00013644; Pre-results.

SUBMITTER: Kowark A

PROVIDER: S-EPMC6196806 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Improve hip fracture outcome in the elderly patient (iHOPE): a study protocol for a pragmatic, multicentre randomised controlled trial to test the efficacy of spinal versus general anaesthesia.

Kowark Ana A Adam Christian C Ahrens Jörg J Bajbouj Malek M Bollheimer Cornelius C Borowski Matthias M Dodel Richard R Dolch Michael M Hachenberg Thomas T Henzler Dietrich D Hildebrand Frank F Hilgers Ralf-Dieter RD Hoeft Andreas A Isfort Susanne S Kienbaum Peter P Knobe Mathias M Knuefermann Pascal P Kranke Peter P Laufenberg-Feldmann Rita R Nau Carla C Neuman Mark D MD Olotu Cynthia C Rex Christopher C Rossaint Rolf R Sanders Robert D RD Schmidt Rene R Schneider Frank F Siebert Hartmut H Skorning Max M Spies Claudia C Vicent Oliver O Wappler Frank F Wirtz Dieter Christian DC Wittmann Maria M Zacharowski Kai K Zarbock Alexander A Coburn Mark M

BMJ open 20181018 10

<h4>Introduction</h4>Hip fracture surgery is associated with high in-hospital and 30-day mortality rates and serious adverse patient outcomes. Evidence from randomised controlled trials regarding effectiveness of spinal versus general anaesthesia on patient-centred outcomes after hip fracture surgery is sparse.<h4>Methods and analysis</h4>The iHOPE study is a pragmatic national, multicentre, randomised controlled, open-label clinical trial with a two-arm parallel group design. In total, 1032 pat ...[more]

PMID: 30341135

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Project description:ObjectiveOlder patients with hip fractures who are undergoing surgery are at high risk of significant mortality and morbidity including postoperative delirium. It is unclear whether different types of anaesthesia may reduce the incidence of postoperative delirium. This systematic review will investigate the impact of anaesthetic technique on postoperative delirium. Other outcomes included mortality, length of stay, complications and functional outcomes.DesignSystematic review of randomised controlled trials and non-randomised controlled studies.Data sourcesBibliographic databases were searched from inception to June 2018. Web of Science and ZETOC databases were searched for conference proceedings. Reference lists of relevant articles were checked, and clinical trial registers were searched to identify ongoing trials.Eligibility criteriaStudies were eligible if general and regional anaesthesia were compared in patients (aged 60 and over) undergoing hip fracture surgery, reporting primary outcome of postoperative delirium and secondary outcomes of mortality, length of hospital stay, adverse events, functional outcomes, discharge location and quality of life. Exclusion criteria were anaesthetic technique or drug not considered current standard practice; patients undergoing hip fracture surgery alongside other surgery and uncontrolled studies.ResultsOne hundred and four studies were included. There was no evidence to suggest that anaesthesia type influences postoperative delirium or mortality. Some studies suggested a small reduction in length of hospital stay with regional anaesthesia. There was some evidence to suggest that respiratory complications and intraoperative hypotension were more common with general anaesthesia. Heterogeneity precluded meta-analysis. All findings were described narratively and data were presented where possible in forest plots for illustrative purposes.ConclusionsWhile there was no evidence to suggest that anaesthesia types influence postoperative delirium, the evidence base is lacking. There is a need to ascertain the impact of type of anaesthesia on outcomes with an adequately powered, methodologically rigorous study.Prospero registration numberCRD42015020166.

Project description:INTRODUCTION:Hip fracture in elderly people is a global public health problem, with substantial associated mortality and disability. Nearly all patients with hip fracture undergo surgical treatment, but optimal anaesthesia for hip fracture surgery in elderly patients is still inconclusive. Ultrasound-guided combined lumbar and sacral plexus block has been widely used in hip fracture surgery in recent years, especially for some high-risk patients. However, it is not clear whether it can improve the postoperative outcomes of elderly patients with hip fracture. METHOD AND ANALYSIS:This research project is a two-arm, parallel, multicentre, prospective randomised controlled trail. A total of 1086 patients aged 75 and older scheduled for hip fracture surgery in five clinical trial centres of China will be randomised in a 1:1 ratio to receive either combined lumbar and sacral plexus block plus sedation or general anaesthesia. The primary outcome will be the postoperative 1-year all-cause mortality. The secondary outcomes will be the incidence of postoperative complications, high-sensitivity cardiac troponin T, early mobility after surgery, postoperative Visual Analogue Scale pain scores, postoperative delirium, length of stay in intensive care unit and hospital, cost-effective outcomes, Barthel Index and incidence of adverse events after discharge. Assessments will be conducted in four steps: preoperative, intraoperative, in-hospital data collection and post-discharge telephone follow-up. ETHICS AND DISSEMINATION:This study has been supported by Shanghai Municipal Commission of Health and Family Planning Foundation for Key Developing Disciplines (2015ZB0103) and approved by the Ethics Committee of Shanghai Sixth People's Hospital [No: 2016-28-(2)]. At the time of manuscript submission, the protocol version is V.1.6 (March 2nd, 2018) with one subsequent approved amendment. Results will be disseminated via an international peer-reviewed publication. TRIAL REGISTRATION NUMBER:NCT03318133.

Project description:BackgroundCircadian rhythm disturbance is common postoperatively in older patients with hip fractures, which may contribute to the development of postoperative delirium (POD). As a reliable biomarker of endogenous circadian rhythms, melatonin regulates the sleep-wake cycle and environmental adaptation, and its secretory rhythm may be modified by anaesthesia and surgery. This study compared the impact of subarachnoid anaesthesia (SA) and general anaesthesia (GA), on the peak of melatonin secretion (primary outcome), the circadian rhythm of melatonin, cortisol and sleep, and the POD incidence (secondary outcome).MethodsIn this prospective cohort observational study, hip fracture surgery patients were enrolled and assigned to receive either SA or GA. Postoperative plasma melatonin and cortisol levels were dynamically measured every six hours on seven time-points, and the circadian rhythm parameters including mesor, amplitude, and acrophase were calculated. Subjective and objective sleep assessments were performed by sleep diaries and sleep trackers, respectively. The Confusion Assessment Method was used twice daily by a specific geriatrician to screen for POD occurrence.FindingsIn a cohort of 138 patients who underwent hip fracture surgery, the circadian rhythm disruption of the patients in the GA group (n=69) was greater than the SA group (n=69). Compared with SA, GA provided the lower peak concentration, mesor, and amplitude of melatonin secretion on postoperative day 1 (p < 0.05). Patients in the GA group experienced higher awakenings, more sleep deprivation, and poor sleep quality on surgery day (p < 0.05). A proportion of 12 patients in the SA group (17.4%) and 24 patients in the GA group (34.8%) experienced POD (p = 0.020).InterpretationThese results suggest that SA may be superior to GA in elderly patients undergoing hip fracture surgery as SA is associated with less impairment of the melatonin rhythm and sleep patterns, and fewer POD occurrences.FundingThe study was supported by the National Natural Science Foundation of China (81971012, 81873726, 81901095, 81701052, and 81801070), Key Clinical Projects of Peking University Third Hospital (BYSYZD2019027), and Peking University "Clinical Medicine plus X" Youth Project (PKU2020LCXQ016).

Project description:PurposeHip fractures are a common health problem among the elderly with an increasing incidence. They are associated with high mortality and morbidity. Optimal pain management remains challenging and inadequate pain control is known for negatively affecting outcomes. Loco-regional anaesthetics (LRA) have been proven to benefit pain management and to lower the risks of opioid use and -related side effects. We aimed to evaluate the use and efficacy of different LRA in elderly hip fracture patients.MethodsSingle-center cohort study of elderly hip fracture patients, who were treated in central Switzerland. We compared patients who received LRA in the form of a femoral nerve block (FNB) or a continuous femoral nerve catheter (CFNC) with patients who did not receive LRA. Primary outcomes were pain-as measured in perioperative morphine use-hospital length of stay (HLOS), postoperative complications, postoperative falls and mortality.Results407 patients were included for analysis. Mean age was 85.2 (SD6.3). There was a significant difference in intraoperative morphine use between the groups (p = 0.007). Postoperative morphine use differed significantly and was lowest in patients with FNB and highest in patients without LRA (p < 0.001). The use of LRA was a significant predictor for postoperative morphine use for postoperative morphine use at the recovery room and for postoperative morphine use 48 h after surgery. No significant differences were found in postoperative complications, a significant difference was found in 1-year mortality.ConclusionsThis article shows that LRA in the form of FNB and CFNC causes a significant decrease in postoperative opioid consumption. Differences between single-shot FNB or CFNC were minimal. There were no significant differences in clinical outcomes such as HLOS, delirium, 30-day and 90-day mortality and postoperative falls. We suggest that use of LRA should be incorporated in the perioperative treatment of elderly patients with a hip fracture. For future research, we recommend evaluating the number of postoperative complications and mortality.

Project description:IntroductionPostoperative delirium (POD) is a common serious postoperative complication especially in older people and is associated with increased mortality, morbidity and healthcare costs. There is no clear consensus which anaesthesia is associated with less incidence of POD for older patients. We aim to assess whether regional anaesthesia results in lower incidence of POD comparing with general anaesthesia (GA) among older patients undergoing hip fracture surgery.Methods and analysisRAGA-delirium is a pragmatic, multicentre, prospective, parallel grouped, randomised controlled clinical trial comparing RA or GA for hip fracture surgery. A total of 1000 patients who are 65 years or over and who are having planned hip fracture surgery in nine clinical trial centres of China will be randomised in a 1:1 ratio to receive either anaesthesia for the surgery. The primary endpoint will be the incidence of POD at day 7. The secondary endpoints will be the subtype, severity and duration of delirium, postoperative acute pain score, incidence of other postoperative non-delirium complications, quality of life and cost-effective outcomes. Randomisation will be performed at the patient level using computer-generated assignment. Outcome assessors will be blinded from intervention assignment. Assessments will be conducted before surgery, intraoperatively, postoperatively, during the hospital stay, at 30-day, 6-month and 1-year postoperative intervals.Potential impact of studyThis study will provide clinical evidence with a more robust methodology to help anaesthetists in selecting appropriate anaesthesia for older patients with high risk for POD. At the era of increasing emphasis on delirium prevention, this trial has the potential to inform the future national guideline to reduce POD.Ethics and disseminationEthical approved by the local institutional review board. Trial results will be presented at national and international academic conferences, and published in peer-reviewed journals.Trial registration numberClinicalTrials.gov (NCT02213380); pre-results.

Dataset Information

Improve hip fracture outcome in the elderly patient (iHOPE): a study protocol for a pragmatic, multicentre randomised controlled trial to test the efficacy of spinal versus general anaesthesia.

Publications

Improve hip fracture outcome in the elderly patient (iHOPE): a study protocol for a pragmatic, multicentre randomised controlled trial to test the efficacy of spinal versus general anaesthesia.

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