Effects of liposomal bupivacaine in preoperative fascia iliac block on postoperative pain and delirium in elderly patients undergoing hip fracture surgery: a study protocol for a randomised, parallel controlled prospective clinical study.

Hao, Y ; Li, W ; et al.

In: BMJ open, Jg. 14 (2024-01-06), Heft 1, S. e079067

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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.

Competing Interests: Competing interests: None declared.

Titel:	Effects of liposomal bupivacaine in preoperative fascia iliac block on postoperative pain and delirium in elderly patients undergoing hip fracture surgery: a study protocol for a randomised, parallel controlled prospective clinical study.
Autor/in / Beteiligte Person:	Hao, Y ; Li, W ; Zheng, M ; Li, X ; Wu, X ; Yu, Z ; Liu, S ; Li, J ; Xu, H
Link:	Full Text Finder (Volltext)
Zeitschrift:	BMJ open, Jg. 14 (2024-01-06), Heft 1, S. e079067
Veröffentlichung:	[London] : BMJ Publishing Group Ltd, 2011-, 2024
Medientyp:	academicJournal
ISSN:	2044-6055 (electronic)
DOI:	10.1136/bmjopen-2023-079067
Schlagwort:	Aged Humans Prospective Studies China Pain, Postoperative drug therapy Pain, Postoperative prevention & control Anesthetics, Local therapeutic use Bupivacaine therapeutic use Randomized Controlled Trials as Topic Hip Fractures surgery Delirium etiology Delirium prevention & control
Sonstiges:	Nachgewiesen in: MEDLINE Sprachen: English Publication Type: Clinical Trial Protocol; Journal Article; Research Support, Non-U.S. Gov't Language: English [BMJ Open] 2024 Jan 06; Vol. 14 (1), pp. e079067. <i>Date of Electronic Publication: </i>2024 Jan 06. MeSH Terms: Hip Fractures* / surgery ; Delirium* / etiology ; Delirium* / prevention & control ; Aged ; Humans ; Prospective Studies ; China ; Pain, Postoperative / drug therapy ; Pain, Postoperative / prevention & control ; Anesthetics, Local / therapeutic use ; Bupivacaine / therapeutic use ; Randomized Controlled Trials as Topic References: J Gerontol A Biol Sci Med Sci. 2000 Sep;55(9):M527-34. (PMID: 10995051) ; J Gerontol A Biol Sci Med Sci. 2003 Jan;58(1):76-81. (PMID: 12560416) ; Br J Anaesth. 2021 Sep;127(3):424-434. (PMID: 34218905) ; Int J Emerg Med. 2010 Nov 06;3(4):321-5. (PMID: 21373300) ; J Orthop Traumatol. 2009 Sep;10(3):127-33. (PMID: 19690943) ; Pain. 2003 Jun;103(3):303-311. (PMID: 12791436) ; J Arthroplasty. 2016 Jul;31(7):1510-5. (PMID: 26872584) ; Ann Intern Med. 2013 Feb 5;158(3):200-7. (PMID: 23295957) ; Curr Med Res Opin. 2017 Jul;33(7):1283-1290. (PMID: 28375752) ; Can J Anaesth. 2019 Dec;66(12):1489-1500. (PMID: 31264195) ; Ann Intern Med. 1990 Dec 15;113(12):941-8. (PMID: 2240918) ; J Clin Med. 2021 Aug 15;10(16):. (PMID: 34441882) ; Eur J Anaesthesiol. 2017 Apr;34(4):192-214. (PMID: 28187050) ; Anesthesiology. 2019 Sep;131(3):477-491. (PMID: 31166241) ; N Engl J Med. 2017 Nov 23;377(21):2053-2062. (PMID: 29166235) ; Int J Surg. 2021 Sep;93:106063. (PMID: 34411752) ; JAMA. 2010 Jul 28;304(4):443-51. (PMID: 20664045) ; Int Psychogeriatr. 2007 Apr;19(2):197-214. (PMID: 16973101) ; BMJ. 2006 Jul 1;333(7557):27-30. (PMID: 16809710) ; J Am Geriatr Soc. 2004 Dec;52(12):2062-8. (PMID: 15571543) ; Orthop Traumatol Surg Res. 2022 Feb;108(1):103151. (PMID: 34826609) ; Reg Anesth Pain Med. 2022 May 30;:. (PMID: 35636781) ; Ann Intern Med. 2011 Aug 16;155(4):234-45. (PMID: 21844549) ; Geriatr Orthop Surg Rehabil. 2016 Jun;7(2):100-5. (PMID: 27239384) ; Int J Geriatr Psychiatry. 2021 Jan;36(1):3-14. (PMID: 32833302) ; Crit Care Med. 2001 Jul;29(7):1370-9. (PMID: 11445689) ; BMC Med. 2014 Oct 08;12:141. (PMID: 25300023) ; Ann Pharmacother. 2016 Sep;50(9):706-11. (PMID: 27289131) ; Lancet. 2014 Mar 8;383(9920):911-22. (PMID: 23992774) ; Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. (PMID: 12421743) ; Medicine (Baltimore). 2017 Jun;96(25):e7190. (PMID: 28640101) ; J Arthroplasty. 2022 Aug;37(8):1549-1556. (PMID: 35351553) ; N Engl J Med. 1988 Nov 24;319(21):1392-7. (PMID: 3185650) Contributed Indexing: Keywords: ANAESTHETICS; Hip; NEUROLOGY Molecular Sequence: ChiCTR ChiCTR2300074022 Substance Nomenclature: 0 (Anesthetics, Local) ; Y8335394RO (Bupivacaine) Entry Date(s): Date Created: 20240106 Date Completed: 20240108 Latest Revision: 20240201 Update Code: 20240201 PubMed Central ID: PMC10773377

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