PONE-D-20-15831

Ultrasound-guided internal branch of superior laryngeal nerve block on postoperative sore throat

PLOS ONE

Dear Dr. Zhipeng Li

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Ehab Farag, MD FRCA FASA

Academic Editor

PLOS ONE

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

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Reviewer #1: Yes

Reviewer #2: Partly

Reviewer #3: Yes

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: I Don't Know

Reviewer #2: No

Reviewer #3: No

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Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: No

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5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Why the comparison was between US guided versus non US guided internal branch of superior laryngeal nerve block

Cost of the technique and experiences and instruments needed is required to discuss

Please compare between both groups as regards length and type of the surgery done as it may affect results

Was aspiration score was done

Clarify or how long period the internal branch of superior laryngeal nerve block work

Reviewer #2: The objective of this study is to conduct a two-arm RCT to evaluate the comparative effectiveness of the USG-guided iSLN block (group S), versus the inhalation (group I) to treat POST. While the study objectives sound interesting, some shotcomings were observed, in regards to abiding by the CONSORT guidelines for conducting and reporting results of high-quality RCTs. A model paper to follow abiding by the CONSORT guidelines is below:

https://www.sciencedirect.com/science/article/pii/S0889540619300010

The study, however, is registered within the Chinese CT Registry, and is accessible via a ChiCTR number.

Methods:

An orderly manner for Methods reporting is suggested, following CONSORT guidelines, without repeating information, such as Trial Design, Participant Eligibility Crtieria and settings, Interventions, Outcomes, sample size/power considerations, Interim analysis and stopping rules, Randomization (details on random number generation, allocation concealment, implementation), Blinding issues, etc. The authors are advised to create separate subsections for each of the possible topics (whichever necessary), and that way produce a very clear writeup. Please find some particular comments:

(a) Randomization: For instance, the steps of sequence generation (methods used to generate random allocation sequence), allocation concealment (methods to implement random allocation sequences) and blinding should be made very clear. Note, allocation concealment and blinding are not the same thing, and should be reported separately. The trial staff recruiting patients should not have the randomization list. Randomization should be prepared by the trial statistician, and he/she would not participate in the recruiting. Also, was a (block) randomization performed? If block, then what's the block size? Those details are necessary. How was the allocation sequence generated?

(b) Sample size/Power: A statement on sample size/power in the manuscript is presented, but it is not clear what (statistical) test was used, the effect size, etc. Those need to be clearly stated.

(c) Study Design & Statistical Analysis: The study has a relatively short duration; I wonder how meaningful it is to evaluate the effects via the repeated measures ANOVA? Also, the statistical analysis entirely relied on Gaussian assumptions of the responses; was it guaranteed? Also after conducting ANOVA, how was multiplicity testing adjusted to compare between various time-points?

In general, what is the perspective of this study once the 48 hours has passed?

Reviewer #3: Li and colleagues present in this paper results of a formally correct study to test the efficacy of ultrasound-guided internal branch of superior laryngeal nerve block on postoperative sore throat. Although, the following considerations should be considered to strenghten the paper:

1. The population sample is calculated on the basis of VAS score at 2h (T4): only T4 should be considered as primary outcome for sample size calculation, the other timepoints should be considered as secondary outcomes.

2. The VAS score was calculated only considering throat pain or postoperative pain can interfere in the evaluation?

3. The kind of surgeries should be specified in the results.

4. The paper needs editing by a proficient English speaker for orthography, language and punctuation.

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Reviewer #1: Yes: Mohammad Waheed El-Anwar

Reviewer #2: No

Reviewer #3: No

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Ultrasound-guided Internal Branch of Superior Laryngeal Nerve Block on Postoperative Sore Throat: A Randomized Controlled Trial

PONE-D-20-15831R1

Dear Dr.Zhang Jinfang

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

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Kind regards,

Ehab Farag, MD FRCA FASA

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments: