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Abstract
Introduction Alleviating postoperative pain from developmental dysplasia of the hip (DDH) surgery is beneficial for paediatric patients. The most commonly used anaesthetic approach currently is general anaesthesia combined with regional nerve blocks. Existing research primarily focuses on studies comparing regional nerve blocks with placebo controls, or studies comparing two different regional nerve blocking techniques. However, the conclusions from these studies offer limited assistance to clinicians in selecting the safest and most effective nerve block. Therefore, we plan to conduct a systematic review and network meta-analysis to compare the efficacy and safety of different regional nerve blocks in managing postoperative pain in children undergoing surgery for DDH.
Methods and analysis We will systematically search the following databases: MEDLINE, Embase, Cochrane Central Register of Controlled Trials via Ovid, as well as the Chinese databases CNKI and Wanfang. We will comprehensively search from the inception of each database to April 2024 and will include randomised controlled trials without restrictions on language or publication status. The primary outcome are postoperative pain scores at 4 hours following surgery. The quality of all included trials will be assessed using version 2 of the Cochrane Randomised Trial Risk of Bias Tool. We will employ the GeMTC package in R software for both direct and indirect comparisons within a Bayesian framework using a random effects model. Additionally, the Confidence in Network Meta-Analysis method will be employed to assess the quality of evidence.
Ethics and dissemination Ethical approval is not required for this study, as it exclusively involves the compilation of published data. We plan to submit our review to academic conferences and peer-reviewed scholarly journals.
PROSPERO registration number CRD42024527459.
- Pain management
- Paediatric anaesthesia
- Anaesthesia in orthopaedics
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Strengths and limitations of this study
A comprehensive systematic review and network meta-analysis accessing multiple databases ensure robust analysis.
The use of the GeMTC package in R allows for sophisticated statistical comparisons between regional nerve blocks.
Quality assessment follows the Cochrane Risk of Bias Tool (RoB 2), enhancing methodological rigour.
Inclusion of randomised controlled trials without language restrictions helps minimise selection bias.
Potential variability in anaesthesiologist skill and patient responses may affect the generalisability of the findings.
Introduction
Developmental dysplasia of the hip (DDH) is a complex disorder that includes a range of hip conditions such as neonatal instability, acetabular or femoral dysplasia, hip subluxation and hip dislocation.1–3 This term has replaced the traditional term of congenital dislocation of the hip (CDH).4 The prevalence of DDH in infants aged 0–12 months is approximately 1/100, with a higher risk observed in females.5 As the child ages, untreated DDH can lead to significant discomfort, pain and osteoarthritis, necessitating interventions such as total hip replacement.6 Early detection and conservative management, such as the use of a Pavlik harness, are crucial for improving the quality of life of affected children. When necessary, treatments may include closed or open reduction, and even femoral or pelvic osteotomy.7
The surgical treatment of children often involves acetabular and femoral reconstruction, along with potential femur or pelvic osteotomy if necessary. It is crucial to note that such procedures may lead to significant postoperative pain8 9which elevates the risk of delayed wound healing and is also associated with an increased occurrence of persistent chronic postoperative pain.10 11 The satisfactory alleviation or prevention of postoperative pain is also a key expectation among parents.12 The improvement of postoperative pain management in children is not only an ethical concern, but also a crucial healthcare issue in perioperative care. Currently, the anaesthetic approach combining general anaesthesia with neural blockade is safe and effective in alleviating postoperative pain in paediatric orthopaedic surgeries.13 14 With the continuous advancements in ultrasonography, an increasing variety of regional neural blockades is being developed for use in anaesthesia for paediatric DDH surgeries. These include caudal block, supra-inguinal fascia iliaca compartment block, lumbar plexus block and quadratus lumborum block, among others.15–18 Existing studies primarily focus on comparisons between regional neural blockade and control groups without intervention, or between two different neural blockade techniques. However, the conclusions of these studies offer limited assistance to clinicians in selecting the safest and most effective neural blockade options.
The aim of this study is to conduct a comprehensive systematic review and network meta-analysis to compare the efficacy and safety of various regional nerve blocks for postoperative analgesia in paediatric patients with DDH.
Methods
The planned start date for the study is 12 April 2024, and the planned end date is 30 June 2025. We have conducted a preliminary search to assess the feasibility of the search terms and are currently refining these terms. We expect to complete the study selection process by December 2024. Data extraction and statistical analysis are planned to commence on January 2025. The study (CRD42024527459) has been registered with the International Registry for Prospective Systems Evaluation (PROSPERO).19 The reporting of this study aligns with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines.20
Patient and public involvement
Patients and/or the public were not involved in the design, conduct, reporting or dissemination plans of this research.
Data sources and searches
We will search the following databases via Ovid: Medline, Embase and the Cochrane Central Register of Controlled Trials. We will also search the Chinese databases CNKI and Wanfang. The search will encompass all databases from their inception until April 2024 without language restrictions. In addition to the database search, we will also employ backward snowballing by reviewing the references of relevant prior publications to identify additional eligible studies that may not be captured in the initial search. The key search terms include developmental dysplasia of the hip, congenital dislocation of the hip, congenital hip dislocation, anaesthesia, analgesia, nerve block and pain management. The complete search terms were provided in the attachment (online supplemental file 1). The final search strategy will be presented in the review.
Supplemental material
A preliminary search was conducted on 22 April 2024 to test the feasibility of the search strategy. The preliminary search yielded the following results: Ovid (MEDLINE: 120, Cochrane: 54, Embase: 366), CNKI: 251 and Wanfang: 353. Given the relatively small number of eligible studies retrieved, we plan to further optimise the search strategy during the formal study phase.
Inclusion criteria
Types of participants
We will include paediatric patients (≤12 years old) who underwent open reduction surgery for DDH.
Types of interventions
We will include studies with various regional nerve block modalities, including sacral canal block, iliac fascia space block, lumbar plexus block, quadrate lumbo-block (III), and others.
Types of comparisons
We will compare different regional nerve blocks with each other with placebo.
Types of outcomes
The primary outcome measure is the pain score 4 hours postsurgery. Secondary outcome measures include pain scores at 2-hour, 6-hour and 24-hour postsurgery, parental satisfaction scores and the incidence of postoperative adverse reactions such as nausea and vomiting, urinary retention and emergence agitation.
Types of study
We will only include randomised controlled trials, irrespective of their language or publication status.
Study selection
The titles, abstracts and full texts of all retrieved studies will be independently reviewed and screened by two researchers (YZ and CF). Reasons for nonconformity will be documented, and any objections will be addressed through consultation with the third author (LY). The process of study selection will be illustrated using the PRISMA flow diagram.
Data extraction and quality assessment
Each data item will be independently extracted by two researchers (YZ and CF). If the full text is not accessible, efforts will be made to contact the authors of the relevant studies. We will make two attempts to contact the authors, with the second attempt set 1 week after the initial contact if no response is received. Specifically, the data retained for analysis include the first author, year of publication, name of the journal, study subjects, gender, age, intervention measures, control measures, the medications and concentrations used in different measures, the size of each group, follow-up time points, types of pain rating scales (such as FLACC (Face, Legs, Arms, Crying, Consolability pain scale), CRIES (Cries, Requires Oxygen, Increased Vital Signs, Expression, Sleeplessness), CHEOPS (Children’s Hospital of Eastern Ontario Pain Scale), VAS (Visual Analogue Scale), etc), adverse reactions and the number of occurrences. See the appendix for the data extraction form (online supplemental file 2).
Supplemental material
Two researchers (YZ and CF) will independently assess the quality of all included trials using the Cochrane Randomised Trial Risk Bias Tool (RoB 2) version 2.0, as detailed in the Cochrane Manual for Systematic Review of Interventions.21 The assessment of the RoB 2 will include the following five domains: bias arising from the randomisation process, bias due to deviations from intended interventions, bias due to missing outcome data, bias in measurement of the outcome and bias in selection of the reported result. Each domain will be assigned one of three bias risk judgments: low risk of bias, some concern or high risk of bias. The overall risk of bias was assessed based on the evaluation results of five modules, where it was classified as low risk if all modules were assessed as low risk of bias; as potential risk if none of the modules were assessed as high risk but at least one module was assessed as having potential risk; and as high risk if at least one module was assessed as high risk or if multiple modules were assessed as having potential risk. Any discrepancies between the researchers will be resolved through discussion. We will report the bias risk table and summary figure in the final review process.
In case a report is published in a language that the researchers are not proficient in, professional translation services will be employed to ensure accurate data extraction. This approach ensures that language barriers do not affect the inclusion and analysis of relevant studies.
Statistical analysis
For dichotomous data, we will calculate the risk ratio (RR) with 95% CI. For continuous data, we will calculate the mean difference (MD) with a 95% CI. If results are reported as median and IQR, mean (95% CI), they will be converted to mean±SD.22–26 Additionally, we will calculate the standardised mean difference (SMD) with a 95% CI for continuous data results across various scales.
We will use the GeMTC package in R software to perform direct and indirect comparisons within a Bayesian framework using a random effects model. Network graphs and ranking probabilities will be generated and presented. If the number of studies included in the network meta-analysis are more than 10, we will generate a funnel plot to assess potential publication bias.27 We will use the X2 test and the I 2 statistic to quantify the heterogeneity. The presence of substantial statistical heterogeneity will be taken into account when the p value is <0.05, and significant heterogeneity will be considered when the I 2 statistic is >50%. In the presence of substantial statistical heterogeneity, clinical heterogeneity will be explored through subgroup analysis, focusing on (1) different types of local anaesthetics (including variations in concentration), (2) age groups (less than 6 years or 6 years and older) and (3) surgical approaches (eg, with or without osteotomy). The sensitivity analysis will be performed by excluding studies with an overall high risk of bias or small sample sizes, as well as by employing various statistical methods, such as fixed-effect models. The transferability of study findings will be considered based on similarities in patient characteristics, interventions, outcomes and study design. The node-splitting method will be used to evaluate inconsistencies, with a p value > 0.05 suggesting that the discrepancies between direct and indirect comparisons are not statistically significant. When inconsistencies are present, the estimated effect size will be determined based on the results of direct comparisons.
Assessing the quality of evidence
We will use the Confidence in Network Meta-Analysis approach to evaluate the quality of evidence. The methodology encompasses six key domains: (1) within-study bias, (2) reporting bias, (3) indirectness, (4) imprecision, (5) heterogeneity and (6) incoherence.28
Ethics and dissemination
Ethics approval is not required for this protocol because we will only pool published data. We plan to submit our review to academic conferences and peer-reviewed academic journals.
Ethics statements
Patient consent for publication
References
Footnotes
YZ and CF contributed equally.
Contributors YZ and LY conceived of the study, led its design and coordination and drafted the manuscript. WJ and ZQ contributed to the study design, were involved in the acquisition of data and assisted in the statistical analysis using the GeMTC package. YZ and CF conducted the systematic literature search and data extraction. All authors have approved the publication of this protocol. LY is the guarantor.
Funding This research was supported by Sichuan Science and Technology Program (2023ZYD0168).
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.