Abstract
BackgroundPostoperative nausea and vomiting (PONV) are common in posterior lumbar intervertebral fusion (PLIF) patients undergoing general anesthesia. The previous clinical observation has shown that a traditional acupoint herbal plaster (AHP) is beneficial to patients with PONV. This trial aims to assess the effect of the AHP for the prevention and treatment of PONV after PLIF in patients with general anesthesia.MethodsA multicenter, parallel, randomized controlled trial (RCT) will be conducted. A total of 166 participants will be randomized to either a treatment group receiving an AHP or a control groups receiving an acupoint placebo plaster (APP) in a 1:1 ratio. The primary outcomes are the first occurrence and frequency of nausea and vomiting. The secondary outcomes include the severity grading of nausea and vomiting using a visual analog scale (VAS) measurement system, quality of life, and serological indicators. The safety evaluation is mainly about adverse events and skin reactions’ observation. Assessments will be carried out at the baseline, day 1, and day 2 (the end of the intervention). The central randomization system in the clinical trial (http://124.205.181.142:8082/xwtf/) will be used to conduct random allocation.DiscussionThis scientific methodology design of the trial is expected to provide clinical evidence to support the AHP for the prevention and treatment of PONV.Trial registrationThis study is retrospectively registered with the Chinese Clinical Trial Registry (http://www.chictr.org.cn) on 19 April 2018. ID: ChiCTR1800015768.
Highlights
Background and rationale {6a} Postoperative nausea and vomiting (PONV) are some of the most common and undesirable side effects of conventional anesthesia surgery [1,2,3]
The incidence of PONV after general anesthesia may reach as high as 30~50% [4]
Existing consensus guidelines from the American Society for enhanced recovery (ASER) recommended a variety of medications that worked at different receptor sites, such as antihistamines, steroids, and so on [11]
Summary
A multicenter, parallel, randomized controlled trial (RCT) will be conducted. A total of 166 participants will be randomized to either a treatment group receiving an AHP or a control groups receiving an acupoint placebo plaster (APP) in a 1:1 ratio. The primary outcomes are the first occurrence and frequency of nausea and vomiting. The secondary outcomes include the severity grading of nausea and vomiting using a visual analog scale (VAS) measurement system, quality of life, and serological indicators. The safety evaluation is mainly about adverse events and skin reactions’ observation. Assessments will be carried out at the baseline, day 1, and day 2 (the end of the intervention). The central randomization system in the clinical trial (http://124.205.181.142:8082/xwtf/) will be used to conduct random allocation
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