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Published in: Trials 1/2019

Open Access 01-12-2019 | Ultrasound | Study protocol

Effect of ultrasound-guided lumbar plexus block on emergence agitation in children undergoing hip surgery: study protocol for a randomized controlled trial

Authors: Hui Zhang, Qing Fan, Junfeng Zhang, Bin Wu, Xiaofeng Wang, Yu Zhang, Aizhong Wang

Published in: Trials | Issue 1/2019

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Abstract

Background

Emergence agitation (EA) is a common postoperative issue in children that causes self-injury, increases stress on healthcare team members, and even leads to postoperative maladaptive behavioral changes in children. Clear answers regarding a ‘gold standard’ for prevention of EA are not available. Pain is regarded as an important causative factor of EA, and ultrasound-guided lumbar plexus block is a safe and efficient anesthetic method that can provide satisfactory pain relief in pediatric hip surgery. The purpose of our study is to determine whether ultrasound-guided lumbar plexus block can reduce the incidence of EA in children undergoing hip surgery.

Methods/design

We designed a prospective, randomized, controlled, blinded trial to determine the effect of ultrasound-guided lumbar plexus block on EA. A total of 100 American Society of Anesthesiologists class I–II children (1–6 years old) scheduled for elective hip surgery will be recruited for this study. Participants will be randomized at a 1:1 ratio to receive either ultrasound-guided lumbar plexus block or fentanyl after the induction of general anesthesia. The primary outcome is the incidence of EA 30 min after emergence from anesthesia using the Pediatric Anesthesia Emergence Delirium (PAED) score. The secondary outcomes are the severity and duration of EA 30 min after emergence from anesthesia using the PAED score, postoperative pain evaluated by the Children’s Hospital of Eastern Ontario Pain Scale, and the incidence of postoperative adverse events. Randomization will be conducted using a computer-generated randomization schedule. Outcome assessors and data collectors will be blinded to the group allocations. Assessments will be performed before surgery, intraoperatively, and postoperatively at every time point.

Discussion

Our hypothesis in this trial is that ultrasound-guided lumbar plexus block can decrease the incidence of EA in children undergoing elective hip surgery. This trial will provide clinical answers to verify our hypothesis. If our hypothesis is confirmed, the results could provide a safe method to prevent EA.

Trial registration

Chinese Clinical Trial Registry, ChiCTR-INR-17011525. Registered on 30 May 2017.
Appendix
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Metadata
Title
Effect of ultrasound-guided lumbar plexus block on emergence agitation in children undergoing hip surgery: study protocol for a randomized controlled trial
Authors
Hui Zhang
Qing Fan
Junfeng Zhang
Bin Wu
Xiaofeng Wang
Yu Zhang
Aizhong Wang
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-3140-3

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