Completeness of harms and anticoagulation-related reporting in randomised controlled trials of fascial plane blocks in adult cardiac surgery: a systematic review
Year: 2026
Type: study-registration
Abstract: ## Review question In randomised controlled trials (RCTs) evaluating fascial plane blocks in adults undergoing cardiac surgery, how completely are (1) harms and (2) anticoagulation-related practices and block-site bleeding complications reported? Exploratory question: does reporting completeness differ between trials published before (2022 or earlier) and after (2024 or later) the CONSORT Harms 2022 statement? ## Anticipated dates Anticipated start date: 02 November 2026. Anticipated completion date: 28 February 2027. ## Stage of review Preliminary searches: started (scoping search in PubMed, 25 October 2026). Piloting of study selection: not started. Formal screening of search results: not started. Data extraction: not started. Risk of bias assessment: not applicable. Data analysis: not started. ## Named contact Cihan Sedat Aytünür — [email protected] — Department of Anesthesiology and Reanimation, University of Health Sciences, Bursa Yüksek İhtisas Training and Research Hospital, Bursa, Türkiye. ORCID 0000-0001-9342-6710. ## Review team members Cihan Sedat Aytünür (guarantor) — affiliation as above. Serra Topal — Department of Anesthesiology and Reanimation, University of Health Sciences, Bursa City Hospital, Bursa, Türkiye. ORCID 0000-0003-3431-0472. ## Funding sources None. ## Conflicts of interest None. ## Searches We will search MEDLINE (via PubMed), the Cochrane Central Register of Controlled Trials (CENTRAL) and Scopus from inception to the date of the final search. Searches will combine terms for fascial plane blocks with terms for cardiac surgery and a randomised controlled trial filter. Only full-text reports published in English will be included. Reference lists of included trials and relevant reviews will be hand-searched. Conference abstracts, trial protocols and registry-only records will not be included. Records retrieved from the three databases will be merged and deduplicated using reference-management software (Rayyan) before screening. ## Draft PubMed search string (("erector spinae"[tiab] OR parasternal[tiab] OR "pecto-intercostal"[tiab] OR pectointercostal[tiab] OR "transversus thoracis"[tiab] OR "serratus anterior"[tiab] OR "pectoral nerve"[tiab] OR PECS[tiab] OR "rhomboid intercostal"[tiab] OR "fascial plane"[tiab] OR interfascial[tiab] OR "S-PIP"[tiab] OR "D-PIP"[tiab]) AND (block*[tiab] OR "Nerve Block"[Mesh])) AND ("Cardiac Surgical Procedures"[Mesh] OR "cardiac surgery"[tiab] OR "cardiac surgical"[tiab] OR "heart surgery"[tiab] OR "open heart"[tiab] OR sternotomy[tiab] OR "coronary artery bypass"[tiab] OR "valve replacement"[tiab] OR "valve repair"[tiab]) AND ("randomized controlled trial"[pt] OR randomized[tiab] OR randomised[tiab]) ## Condition or domain being studied Reporting quality of perioperative safety (harms) data in regional anaesthesia trials in adult cardiac surgery, with a focus on anticoagulation management and block-site bleeding complications in patients receiving systemic heparinisation. ## Participants RCTs enrolling adults (18 years or older) undergoing elective cardiac surgery via median sternotomy or a minimally invasive approach. Trials with mixed surgical populations will be included only if data for cardiac surgery patients are reported separately. Paediatric trials will be excluded. ## Interventions Any fascial plane block (e.g., erector spinae plane, parasternal/pecto-intercostal, transversus thoracis, serratus anterior, pectoral nerve or rhomboid intercostal block), given as a single injection or via a catheter, alone or combined with another fascial plane block. Trials of combined techniques will be coded as a separate category. Trials of neuraxial or non-fascial-plane peripheral techniques without a fascial plane block arm will be excluded. ## Comparators Any comparator (placebo or sham block, no block, systemic analgesia, or another regional technique). The comparator does not affect eligibility because the unit of analysis is the trial report. ## Types of study to be included RCTs published as full-text articles in English. Observational and quasi-randomised studies, conference abstracts, protocols, letters and reviews will be excluded. ## Context Adult cardiac surgery, where systemic heparinisation for cardiopulmonary bypass and early postoperative anticoagulant or antiplatelet therapy create a specific bleeding-risk context for regional anaesthesia. ## Main outcomes Two co-primary outcomes, assessed for each included trial report: (A) Harms reporting: the proportion of trials reporting both the method and timing of harms ascertainment (CONSORT Harms 2022 item 6a) and the follow-up period for harms (item 14a). (B) Anticoagulation-related reporting: the proportion of trials reporting both the timing of block performance relative to systemic heparinisation (item AK3 of a study-specific checklist) and the monitoring and results of block-site haematoma or bleeding, including zero events (item AK7). ## Measures of effect Proportions with 95% confidence intervals (Wilson method). Exploratory between-period comparisons will be expressed as odds ratios with 95% confidence intervals. ## Additional outcomes Reporting of each CONSORT Harms 2022 item relevant to harms (6a, 6c, 11a, 12a, 13a, 14a, 16, 17a, 17a2, 17b, 17c, 18, 19, 20). Reporting of each item of the study-specific anticoagulation checklist: AK1 preoperative anticoagulant/antiplatelet exclusion criteria; AK2 coagulation laboratory thresholds; AK3 block timing relative to heparinisation; AK4 intraoperative heparin dose or target ACT and protamine reversal; AK5 catheter removal timing relative to postoperative anticoagulation; AK6 citation of ASRA/ESRA anticoagulation guidance; AK7 block-site haematoma/bleeding monitoring and results. Total anticoagulation reporting score (0–7). Frequencies of block-related complications as reported (descriptive only). ## Data extraction (screening process) Title and abstract screening will be performed by one reviewer (CSA). CSA will assess full-text eligibility; a second reviewer (ST) will independently assess a random 20% sample of the full texts, and agreement will be reported with Cohen's kappa, interpreted using standard benchmarks (Landis & Koch). Disagreements will be resolved by discussion; as the review team comprises two reviewers, no independent third adjudicator is available, and this will be reported as a limitation. ## Data extraction (coding process) Data will be coded against a pre-specified coding manual. Each item will be rated as reported, not reported, unclear or not applicable, using decision rules and example wording defined in a 10-trial pilot. Initial coding of all included trials will be performed with the assistance of a large language model (Claude, Anthropic), which will record the supporting text and its location (page, table or supplement) for every item. CSA will verify each code against the source text. ST will independently code a random 20% sample of trials; agreement between ST and the verified codes will be reported with Cohen's kappa, and discrepancies will be resolved by discussion. Use of the AI tool will be reported in the manuscript. ## Trial characteristics to be extracted Publication year, journal and its JIF quartile, country, funding source, trial registration, sample size, block type(s), single-shot or catheter technique, and comparator. ## Risk of bias (quality) assessment Not applicable. The review assesses the completeness of reporting in trial publications, not the effects of interventions. Risk of bias of individual trials will not be assessed and will not influence inclusion. ## Strategy for data synthesis Narrative and tabular synthesis. For each outcome, n/N, percentage and 95% CI will be reported. No meta-analysis of clinical effects will be performed. Exploratory comparison: trials published in 2022 or earlier versus 2024 or later (CONSORT Harms 2022 was published in 2023), using the chi-square or Fisher's exact test and odds ratios with 95% CIs. Trials published in 2023 will be excluded from the main comparison and added in sensitivity analyses, first to the earlier and then to the later group. Multivariable logistic regression will be limited to two pre-specified covariates (publication period and journal JIF quartile) and will be performed only if the smaller outcome category contains at least 20 events; otherwise only univariable analyses will be presented. All statistical analyses will be performed using R (R Core Team, Vienna, Austria). ## Analysis of subgroups or subsets Descriptive and univariable comparisons by block category (individual fascial plane block types versus combined techniques). Sensitivity analyses for trials published in 2023, as described above. ## Type and method of review Systematic review; methodological (meta-research) review of reporting quality. ## Health area of the review Anaesthesia; cardiovascular; surgery; patient safety. ## Language English. ## Country Türkiye. ## Anticipated or actual start of review / Reference and/or URL for review protocol None. This record serves as the protocol. ## Dissemination plans Submission to a peer-reviewed anaesthesia journal and presentation at a scientific congress. ## Keywords Fascial plane block; cardiac surgery; anticoagulation; harms; adverse events; CONSORT; reporting quality; randomised controlled trials. ## Details of any existing review of the same topic by the same authors None. ## Note PROSPERO registration was not pursued because the platform currently supports only the "Intervention review" registration type, which does not match this review's methodological (meta-research) design. This OSF registration serves as the protocol record instead.
Source: Open Science Framework
Authors: Cihan Sedat Aytünür, Serra Topal
Language: English
Subfield: Statistics, Probability and Uncertainty
Field: Decision Sciences
Domain: Social Sciences
Open Access status: green
OpenAlex ID: W7223673369