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

IntroductionHip 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 analysisThe 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 disseminationiHOPE 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 numberDRKS00013644; Pre-results

Comparison of general anaesthesia and regional anaesthesia in terms of mortality and complications in elderly patients with hip fracture: a nationwide population-based study

“…Moreover, the REGARD study comparing RA and GA and their effect on delirium in patients with hip fractures aiming to recruit 100 patients has been registered in the ISRCTN registry (ISRCTN1565914, https://doi.org/10.1186/ISRCTN15165914). A meta-analysis of their results may support our study findings and thus improve guideline development for enhanced outcome after hip fracture surgery 19 20…”

“…The RAGA-delirium trial is planned with 1000 randomised older patients undergoing hip fracture surgery 18. The REGAIN and iHope studies are international, multicentre, pragmatic RCTs including 1600 and 1032 patients, respectively 19 20. Moreover, the REGARD study comparing RA and GA and their effect on delirium in patients with hip fractures aiming to recruit 100 patients has been registered in the ISRCTN registry (ISRCTN1565914, https://doi.org/10.1186/ISRCTN15165914).…”

Effects of Anesthesia Techniques on Outcomes after Hip Fracture Surgery in Elderly Patients: A Prospective, Randomized, Controlled Trial

“…For several decades, it was unclear whether general or regional anesthesia was favorable for hip fracture surgery outcomes, and this issue remains under debate. Currently, two large scale, multicenter randomized clinical trials (RCTs) comparing outcomes after spinal vs. general anesthesia for hip fracture surgery are underway [2,13], which will provide valuable data and insight regarding this issue. A limited number of RCTs to date have compared outcomes after different anesthesia techniques in hip fracture patients.…”

“…The majority of hip fractures are complicated by the fact that the patient population is geriatric with various underlying medical conditions. In Europe and the USA, the 1-month mortality rate after hip fracture is reported to be between 4% and 12%, and as high as 35% after 1 year [2]. To improve patient outcomes, substantial research efforts are being enacted.…”

Anesthetic management of geriatric patients

“…Several ongoing large-scale randomized controlled trials (RCTs) should provide future guidance on the best anesthesia technique for hip surgery in the elderly [83][84][85]. Regardless of the type of anesthesia chosen, anesthesia should be carried out by experienced anesthesiologists who are trained to manage the perioperative care of geriatric patients [62,86].…”