Comparison of combined lumbar and sacral plexus block with sedation versus general anaesthesia on postoperative outcomes in elderly patients undergoing hip fracture surgery (CLSB-HIPELD): study protocol for a prospective, multicentre, randomised controlled trial.

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.