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Thank you very much for your careful and thorough revision of the manuscript and for the detailed point-by-point response to the reviewers.
As the reviewers did not respond in this round, I have re-evaluated the revised manuscript myself with their earlier comments in mind. I am satisfied that you have now:
1) Clarified and justified the study design, block technique, timing, and workflow (including anesthesia preparation time and OR occupancy time);
2) Provided a clear rationale for the use of ESPB in the context of PVP, including the expected anatomical coverage of relevant nociceptive structures;
3) Expanded and updated the introduction and discussion, including the literature context and anticipated clinical implications;
4) Defined outcome measures, adverse event monitoring, and data handling procedures with sufficient detail for reproducibility; and
5) Justified the sample size assumptions and clearly acknowledged the main limitations of the trial.
With these revisions, all substantive concerns raised in the previous review rounds have been adequately addressed.
I am therefore pleased to inform you that your manuscript is accepted for publication in its current form.
[# PeerJ Staff Note - this decision was reviewed and approved by Mike Climstein, a PeerJ Section Editor covering this Section #]
Thank you for your thorough and thoughtful revision. The reviewer has recommended several key revisions. Kindly address all of the reviewer’s comments in full to ensure clarity, methodological transparency, and readiness for acceptance.
The manuscript is clearly written and logically structured; however, a few aspects of basic reporting should be improved to meet publication standards:
Literature context: Expand the introduction to include a more comprehensive background on previous uses of the erector spinae plane block (ESPB) in spine or vertebral procedures. This will better demonstrate the existing evidence gap and strengthen the rationale for the study.
Clarity and precision: Minor typographical and formatting corrections are needed (e.g., replace “g 18 years” with “≥18 years,” “VAS g 4” with “VAS ≥ 4,” and remove symbols such as “�” or “¿”).
Abstract: Clearly state the main study hypothesis and primary objective to improve focus and readability.
Language: While the English is generally good, a light professional language edit would enhance fluency and ensure consistent terminology (e.g., “block-to-incision interval,” “moderate-to-severe pain”).
Presentation: Consider adding a simple CONSORT-style figure to summarize patient flow and group allocation, which will improve transparency and readability.
The experimental design is appropriate and well described; however, several clarifications are needed to ensure full reproducibility and methodological transparency:
Block technique: Specify the exact vertebral level at which the ESPB will be performed and whether the injection is at, above, or below the fractured vertebra. This detail is critical for reproducibility and comparison with future studies.
Pain assessment: Clarify how and when intraoperative VAS pain scores will be measured (e.g., during trocar insertion, cement injection, or continuously) and who will collect these data.
Sedation and analgesia: Indicate whether any sedative or anxiolytic medications (e.g., midazolam, dexmedetomidine) will be administered, as this could influence the primary pain outcomes.
Adverse event monitoring: Describe how adverse events will be defined, assessed, and by whom, including the management protocol for potential local anesthetic toxicity or pneumothorax.
Data monitoring and protocol adherence: Include information on whether an independent monitor or data safety oversight mechanism is in place to ensure protocol compliance and data accuracy.
Sample size justification: Provide a reference or pilot data supporting the assumption of a 50% reduction in moderate-to-severe pain used in the power analysis.
The planned analyses and endpoints are generally appropriate; however, several aspects should be clarified or expanded to strengthen the validity and interpretability of the findings:
Effect size justification: The assumed 50% reduction in moderate-to-severe pain (from 70% to 35%) should be justified with reference to pilot data or prior literature. Without supporting evidence, the chosen effect size may overestimate the expected clinical difference.
Outcome measures:
Consider including total perioperative opioid consumption (converted to morphine equivalents) as an additional secondary outcome to provide a more objective measure of analgesic efficacy.
Clarify whether rescue analgesia requirements will be analyzed as binary (yes/no) or quantitative (number/dose of interventions), as this affects statistical interpretation.
Adverse events: Provide more detail on how complications such as local anesthetic systemic toxicity, pneumothorax, or block failure will be confirmed and classified.
Follow-up period: The 24-hour follow-up captures only short-term analgesia; acknowledge that this limited duration precludes assessment of delayed or chronic pain outcomes.
Generalizability: Since the study is single-center and all blocks are performed by one experienced operator, note that results may not generalize to less experienced practitioners or other institutions.
This is a well-prepared and clinically relevant study protocol addressing an essential gap in perioperative pain management for percutaneous vertebroplasty. The rationale is clear, the methodology is generally sound, and ethical standards are appropriately followed. The manuscript will meet publication standards after minor clarifications and language improvements.
Additional suggestions:
Include a simple study flow diagram (CONSORT-style) to summarize recruitment, randomization, and follow-up visually.
Clearly state the anticipated clinical implications of the trial (e.g., potential integration of ESPB into multimodal analgesia for vertebral augmentation).
Revise minor language issues for smoother readability and uniform terminology.
If feasible, briefly mention plans for multicenter validation or longer-term follow-up once short-term results are obtained.
Thank you for your submission. While your study addresses an interesting and clinically relevant topic, the reviewers have raised several important points that need to be addressed before the manuscript can be reconsidered.
Please revise your manuscript thoroughly to address the following key areas:
1) Clarify the methodological design – clearly justify your choice of block approach and its relevance to the ESPB mechanism. The rationale for the lateral approach and the specific anatomical basis should be better explained.
2) Define endpoints and analysis – please specify primary and secondary endpoints more precisely and describe how outcomes were measured and compared.
3) Improve the methodological description – ensure that procedures, control selection, and inclusion/exclusion criteria are described in sufficient detail to ensure reproducibility.
4) Enhance clarity and scientific reasoning – strengthen your discussion to show how your approach adds to the existing literature, and provide clear justification for any deviations from standard or previously validated techniques.
5) Language and structure – please revise the manuscript for clarity and grammatical accuracy to improve overall readability.
After revision, please include a detailed point-by-point response addressing each reviewer comment.
Thank you for the opportunity to review your protocol “Erector spinae plane block for pain management in lumbar percutaneous vertebroplasty: study protocol for a randomized controlled trial”. The study question is timely and the randomized design is appreciated. However, several methodological issues currently limit the scientific rigour and feasibility of the protocol.
1. PVP is routinely performed in the prone position. Performing ESPB with the patient in the lateral decubitus necessitates an additional position change and re-prepping/draping, which prolongs preparing time and may blur any analgesic benefit. Please clarify how you will minimise the time gap between block performance and surgery.
2. ESPB deposits local anaesthetic on the transverse process, leaving the periosteum of the pedicle and the needle track—the main nociceptive sources during PVP—largely unblocked. A short paragraph discussing why ESPB is expected to cover these structures would strengthen the background.
3. Several results should also be considered. Adding “anaesthesia preparation time” and “total operating-room occupancy time” as secondary endpoints would allow readers to judge the real-world efficiency of the intervention.
4. Volume discrepancy: The ESPB group receives 20 mL 0.25 % ropivacaine per side, whereas the control group receives only “1 % lidocaine for local infiltration”. Please explain why an equivalent volume was not chosen for the control group to isolate the “block effect” from the “volume effect”.
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The manuscript is well written, with clear and professional English throughout. The introduction presents a compelling background on the need for improved analgesia during percutaneous vertebroplasty (PVP), and relevant literature is cited appropriately to justify the study rationale.
The article is well-structured according to standard academic conventions, and the use of CONSORT guidelines is noted and appreciated. However, minor formatting and typographical issues should be corrected:
Line 67: “g 18 years” should read “≥ 18 years”.
Line 114: “VASg4” should be corrected to “VAS ≥ 4”.
The manuscript is appropriately self-contained for a study protocol. While no results are presented (as expected in a protocol), the outlined hypotheses and planned outcomes are well aligned. The trial registration, ethical approval, and anonymization processes are properly addressed.
The research question is clearly defined and addresses a meaningful gap in clinical anesthesia practice. ESPB is a promising analgesic technique, but its use in lumbar PVP remains understudied, making this trial both relevant and timely.
The single-center, randomized, single-blind design is appropriate, and the trial adheres to ethical standards. The methods are described in detail, including patient selection, blinding procedures, intervention techniques, and perioperative care. These details should allow for replication by other investigators.
Two areas could benefit from clarification or enhancement:
Recruitment Timeline: While the trial is scheduled to begin in September 2025, please indicate the anticipated duration of recruitment and study completion.
Operator Variability: Since ESPBs will be performed by a single anesthesiologist, consider discussing the generalizability of findings and whether any training or standardization will be introduced for broader application.
As this is a protocol, no findings are yet available. Nonetheless, the planned statistical analyses are appropriate and well described. The use of SPSS, normality testing, and appropriate comparisons (t-tests, Mann-Whitney U, chi-square/Fisher’s exact) are correctly matched to data types.
The sample size calculation is based on clinically meaningful assumptions (70% to 35% incidence reduction), with an appropriate power and significance level, and adjustment for potential dropout.
All proposed outcomes—VAS scores, rescue analgesia, time to mobilization, satisfaction scores—are relevant and reflect real-world clinical priorities. Future conclusions are appropriately limited to results supported by data.
One suggestion:
Handling Missing Data: Please include a short explanation of how missing or incomplete data (e.g., patient withdrawal, missing VAS scores) will be handled statistically.
This is a high-quality and timely clinical trial protocol addressing a critical gap in regional anesthesia for spinal procedures. The manuscript is clear, ethical, and well thought-out, with pragmatic outcomes and rigorous methodology.
The discussion could be slightly expanded to include brief mention of alternative regional techniques (e.g., paravertebral block) as comparators, which would contextualize ESPB further. Additionally, while the 24-hour follow-up period is reasonable, a note on whether long-term outcomes (e.g., persistent pain, opioid use, functional status) may be considered in future work would enhance the discussion.
Overall, only minor revisions are suggested. I look forward to the trial results, which are likely to provide meaningful insights into pain management strategies during PVP.
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