The analgesic efficacy of pericapsular nerve group block in patients with intertrochanteric femur fracture: A randomized controlled trial

Mingjian Kong; Yan Tang; Fei Tong; Hui Guo; Xin Lei Zhang; Lei Zhou; Hua Ni; Bin Wang; Yunqing Liu; Jindong Liu

doi:10.1371/journal.pone.0275793

Peer Review History

Original SubmissionApril 27, 2022
8 Jun 2022 Decision Letter - Ehab Farag, Editor PONE-D-22-10759The analgesic efficacy of pericapsular nerve group block in patients with intertrochanteric femur fracture: a randomized controlled trialPLOS ONE Dear Dr. Mingjian Kong Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. ==============================I would appreciate if you pay careful attention to the reviewers' comments in your response.============================== Please submit your revised manuscript by Jul 23 2022 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. 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We will update your Data Availability statement to reflect the information you provide in your cover letter. 3. We note you have included a table to which you do not refer in the text of your manuscript. Please ensure that you refer to Table 4 in your text; if accepted, production will need this reference to link the reader to the Table. 4. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. 5. Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Partly Reviewer #2: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: No Reviewer #2: Yes ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: No Reviewer #2: Yes ****** 4. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #2: Yes ****** 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: This is an interesting study comparing Peripheral nerve blocks to Fascia iliaca compartment block. The manuscript to structured in a easy to read manner. They a few comments worth addressing. 1. At the end of introduction, can the authors state the primary and secondary objectives. 2. Can the randomisation information include the allocation ratio. 3. Can the authors define their population of analysis for the primary analysis (e.g intent to treat), secondary and safety. 4. Table 1, as this this is an RCT, its recommended not to formally test baseline characteristics, any difference are simply due to chance and also do not serve a useful purpose so p-values should be omitted (see "Comparisons against baseline within randomised groups are often used and can be highly misleading by Bland JM, Altman 2011"). 5. Any correction taken into account for multiple testing, i.e testing in each timepoint, increase you chance of finding a significant result? 6. Can the authors state whether a statistical analysis plan was signed off prior to unblinding? 7. Was there an oversight committee to monitor the safety of patients, its not mentioned in the manuscript? Reviewer #2: Why do you think there was zero incidence of quadriceps motor weakness in the PENG block group compared to prior referenced studies that showed some degree of motor block, although still lower than fascia iliaca? You attributed it related to lower concentration or was the small sample size not adequately powered to detect secondary outcome measurements? Also would have been useful to measure quadriceps muscle strength at timepoints later than 6 hours How was the method of passive exercise testing decided on? Is there a basis for using a 15 degree passive hip elevation? How long after block performance were patients induced and surgery started? As t1 is 30 min post block time, does an increased length of time between block performance and starting the timer at the conclusion of surgery influence block duration when measured postop? The length of surgical time is shown but not the length of time between T1 and T2. Source 13 does not refer to anything relevant to this study - need to edit this ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #2: No ******** [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. 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Revision 1
1 Aug 2022 Author Response Editor 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf. Respected Editors：thanks for your review , modifications have been made in the manuscript as requested. 2. In your Data Availability statement, you have not specified where the minimal data set underlying the results described in your manuscript can be found. PLOS defines a study's minimal data set as the underlying data used to reach the conclusions drawn in the manuscript and any additional data required to replicate the reported study findings in their entirety. All PLOS journals require that the minimal data set be made fully available. For more information about our data policy, please see http://journals.plos.org/plosone/s/data-availability. "Upon re-submitting your revised manuscript, please upload your study’s minimal underlying data set as either Supporting Information files or to a stable, public repository and include the relevant URLs, DOIs, or accession numbers within your revised cover letter. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. Any potentially identifying patient information must be fully anonymized. Important: If there are ethical or legal restrictions to sharing your data publicly, please explain these restrictions in detail. Please see our guidelines for more information on what we consider unacceptable restrictions to publicly sharing data: http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. Note that it is not acceptable for the authors to be the sole named individuals responsible for ensuring data access. We will update your Data Availability statement to reflect the information you provide in your cover letter. Respected Editors：we have uploaded a separate minimal data. 3. We note you have included a table to which you do not refer in the text of your manuscript. Please ensure that you refer to Table 4 in your text; if accepted, production will need this reference to link the reader to the Table. Respected Editors：we have modified this and marked it in the manuscript. 4. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. Respected Editors：We have added the title of the supporting information file to the end of the manuscript. 5.Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. Respected Editors：We have checked the reference list and made corrections to ensure it is complete and correct.(all revisions have been marked in the manuscript) Reviewer 1 1.At the end of introduction, can the authors state the primary and secondary objectives. It has been supplemented in the introduction section of the manuscript.We will be happy to edit the text further, based on helpful comments from the reviewers. 2.Can the randomisation information include the allocation ratio. It has been supplemented in the Randomization and Blinding section of the manuscript.We will be happy to edit the text further, based on helpful comments from the reviewers. 3.Can the authors define their population of analysis for the primary analysis (e.g intent to treat), secondary and safety. It has been supplemented in the discussion section of the manuscript.We will be happy to edit the text further, based on helpful comments from the reviewers. 4.Table 1, as this this is an RCT, its recommended not to formally test baseline characteristics, any difference are simply due to chance and also do not serve a useful purpose so p-values should be omitted (see "Comparisons against baseline within randomised groups are often used and can be highly misleading by Bland JM, Altman 2011"). We thank the reviewer for pointing out thi issue.We studied the document you provided and found that there was a misunderstanding. The baseline written on the form was a clerical error and has been deleted in the text. In our research groups were be compared directly by two-sample methods. 5.Any correction taken into account for multiple testing, i.e testing in each timepoint, increase you chance of finding a significant result? We thank the reviewer for pointing out thi issue. We have taken this situation into consideration,VAS score belongs to grade data and does not conform to the normal distribution, so we use the median (interquartile spacing) for statistical description, and use Kruskal Wallis H test to get the result P < 0.05. It can be considered that the distribution of scores in each group is not the same, and the difference is statistically significant, and then compare them at different time points to find out the positive results. 6.Can the authors state whether a statistical analysis plan was signed off prior to unblinding? This study developed a statistical analysis plan before Unblinding. The staff who conducted the data analysis did not understand the processing methods of each group. They only selected the corresponding statistical analysis method according to the type of data collected, and then unblinded after completing the statistical analysis of each group of data. 7. Was there an oversight committee to monitor the safety of patients, its not mentioned in the manuscript? The Ethics Committee supervised the implementation of this study and protected the rights and interests of patients. Relevant contents have been supplemented in the study design and subjects section of the manuscript. Reviewer 2 Why do you think there was zero incidence of quadriceps motor weakness in the PENG block group compared to prior referenced studies that showed some degree of motor block, although still lower than fascia iliaca? You attributed it related to lower concentration or was the small sample size not adequately powered to detect secondary outcome measurements? Also would have been useful to measure quadriceps muscle strength at timepoints later than 6 hours. We thank the reviewer for pointing out thi issue.We consider that this situation may be the reason for the concentration. The reference study nerve block used 0.5% ropivacaine, and this study used 0.375% ropivacaine. In addition to the time point of 6 hours after operation, we also measured the quadriceps femoris muscle strength at 12 hours and 24 hours after operation, but there was no positive result, so it was not included in the result. How was the method of passive exercise testing decided on? Is there a basis for using a 15 degree passive hip elevation? We refer to reference 15 for the specific methods of passive motion testing.We will be happy to edit the text further, based on helpful comments from the reviewers. How long after block performance were patients induced and surgery started? As t1 is 30 min post block time, does an increased length of time between block performance and starting the timer at the conclusion of surgery influence block duration when measured postop? The length of surgical time is shown but not the length of time between T1 and T2. We thank the reviewer for pointing out thi issue.We made statistics on T1-T2 of patients in each group, and the results were not statistically significant. Table1 has been supplemented with relevant data. Attachments Attachment Submitted filename: Response to Reviewers.doc https://doi.org/10.1371/journal.pone.0275793.r002
26 Sep 2022 Decision Letter - Rizaldy Taslim Pinzon, Editor The analgesic efficacy of pericapsular nerve group block in patients with intertrochanteric femur fracture: a randomized controlled trial PONE-D-22-10759R1 Dear Dr. Kong 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. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Rizaldy Taslim Pinzon Academic Editor PLOS ONE Additional Editor Comments (optional): Thank you for addressing comments from the previous submission. The included tables and figures bring added clarity to the data and results. Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #2: All comments have been addressed ******** 2. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #2: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #2: Yes ****** 4. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #2: Yes ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #2: Yes ****** 6. 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 #2: Thank you for addressing comments from the previous submission. The included tables and figures bring added clarity to the data and results. One comment would be for the addition to the beginning of the discussion section: "We also analyzed the safety of anesthesia related complications after nerve block surgery" - this sentence is unclear, the word surgery probably should not be included after nerve block. ****** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #2: No ******** https://doi.org/10.1371/journal.pone.0275793.r003
Formally Accepted
2 Oct 2022 Acceptance Letter - Rizaldy Taslim Pinzon, Editor PONE-D-22-10759R1 The analgesic efficacy of pericapsular nerve group block in patients with intertrochanteric femur fracture: a randomized controlled trial Dear Dr. Kong: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Rizaldy Taslim Pinzon Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0275793.r004

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