Analgesic effect of premixed nitrous oxide/oxygen on removal of vacuum assisted closure dressings: randomized controlled trial study protocol.

IF 2.8 3区医学 Q1 ORTHOPEDICS

Journal of Orthopaedic Surgery and Research Pub Date : 2025-03-04 DOI:10.1186/s13018-024-05397-1

Yihui Xing, Yali Hou, Cui Li, Weifeng Wang, Chongjian Fu, Lu Tang

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引用次数: 0

Abstract

Background: Vacuum assisted closure (VAC) is an effective treatment that promotes wound healing in clinical practice. However, the pain caused by Vacuum assisted closure VAC dressing removal is still a challenge for patients and medical staff. The purpose of this study was to investigate the analgesic effect and safety of premixed nitrous oxide/oxygen in the treatment of pain caused by VAC dressing removal.

Methods/design: This study is a single center, randomized, placebo-controlled, double-blind clinical trial. A total of 100 patients requiring VAC dressing removal were recruited and randomly divided into an intervention group and a control group. The intervention group will receive routine treatment plus a premixed nitrous oxide/oxygen mixture, and the control group will receive routine treatment plus oxygen. Participants and researchers are all blind to the operation process. The results of each group will be monitored at baseline (T0), 5 min after intervention (T1), and 5 min after finishing intervention (T2), 15 min after finishing intervention (T3). The primary outcome measure was pain intensity. Secondary outcomes included physiological parameters, adverse reactions, operators, and patients' satisfaction.

Discussion: This study will explore the analgesic effect of oxide/oxygen mixture on VAC dressing removal. If it is beneficial to patients with VAC dressing change, it will be helpful for pain management of VAC dressing removal.

Trial registration: Chinese Clinical Trial Register ChiCTR2200056742. Registered on February 13, 2022.

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来源期刊

Journal of Orthopaedic Surgery and Research ORTHOPEDICS-

CiteScore

4.10

自引率

7.70%

发文量

494

审稿时长

>12 weeks

期刊介绍： Journal of Orthopaedic Surgery and Research is an open access journal that encompasses all aspects of clinical and basic research studies related to musculoskeletal issues. Orthopaedic research is conducted at clinical and basic science levels. With the advancement of new technologies and the increasing expectation and demand from doctors and patients, we are witnessing an enormous growth in clinical orthopaedic research, particularly in the fields of traumatology, spinal surgery, joint replacement, sports medicine, musculoskeletal tumour management, hand microsurgery, foot and ankle surgery, paediatric orthopaedic, and orthopaedic rehabilitation. The involvement of basic science ranges from molecular, cellular, structural and functional perspectives to tissue engineering, gait analysis, automation and robotic surgery. Implant and biomaterial designs are new disciplines that complement clinical applications. JOSR encourages the publication of multidisciplinary research with collaboration amongst clinicians and scientists from different disciplines, which will be the trend in the coming decades.