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Abstract
Introduction Postoperative delirium (POD) is the most common acute fluctuating mental state change after hip fractures in older adults. Postoperative pain is a Grade A risk factor for POD and is closely related to the prognosis of patients undergoing hip fracture surgery. The fascia iliac block has a definite analgesic effect and few side effects, and several studies have reported that it reduces the occurrence of POD in patients undergoing general anaesthesia for hip fracture surgery. Liposomal bupivacaine is a local anaesthetic with a long half-life that significantly reduces the use of opioids and is conducive to patient prognosis and recovery. However, whether regional nerve block analgesia can decrease the occurrence of POD in elderly patients undergoing hip fracture surgery has not been reported.
Methods and analysis This is a single-blinded, randomised, parallel-controlled prospective clinical study. Participants will be randomly assigned preoperatively to either the liposomal bupivacaine (ie, Exparel) or ropivacaine groups by block randomisation. Then, the occurrence of POD (primary outcome) and postoperative pain (secondary outcome) will be evaluated.
Ethics and dissemination This research protocol complies with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 guidelines and is approved by the Ethics Committee of Shanghai General Hospital (ID 2023–437). The original data are expected to be released in July 2029 on the ResMan original data-sharing platform (IPD-sharing platform) of the China Clinical Trial Registry, which can be viewed on the following website: http://www.medresman.org.cn.
PROSPERO registration number ChiCTR2300074022.
- ANAESTHETICS
- NEUROLOGY
- Hip
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Footnotes
YH and WL are joint first authors.
Contributors HX, one of the two principal investigators, initially formulated the research ideas and initiated the study’s ethical approval and trial registration. YH, the other principal investigator, wrote the manuscript and completed the ethical approval and trial registration processes, who also will collect and keep all data from this trial. WL, who calculated the sample size, also will perform the preoperative interview and grouping and perform fascia iliac block. MZ will be responsible for the postoperative follow-up work, including the evaluation of POD and pain assessment. SL will assist MZ in her work, including reminding patients who need postoperative follow-up every day and recording the completion of follow-up on that day. XW will perform anaesthesia management for all participants and fill out the anaesthesia record form. ZY will perform the pain control and treatment of POD after surgery. XL will be responsible for data statistics and analysis. All authors contributed to the design of trial protocols. This project was approved by JL and completed under supervision.
Funding This work is supported by the Chinese Red Cross Foundation (CRCF) Special Fund for Medical Empowerment (second batch of 29 in 2023 to HX) and Clinical Research Innovation Plan of Shanghai General Hospital (grant number KD031-ly01 to JL; CTCCR-2021C21 to HX). The funding only gave financial support.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
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