Review articleIntrathecal catheterisation after observed accidental dural puncture in labouring women: update of a meta-analysis and a trial-sequential analysis
Introduction
Labour epidural analgesia can be complicated by accidental dural puncture1 which often leads to post-dural puncture headache (PDPH).2, 3 In the case of an observed dural puncture the catheter can be inserted intrathecally,4 an approach that has become increasingly popular over the last two decades and that was favoured by more than two-thirds of lead obstetric anaesthetists in the UK, according to a survey in 2013.5 The catheter can plug the dural hole, thereby limiting the efflux of cerebrospinal fluid,6 which otherwise results in traction on pain-sensitive structures. Alternatively, epidural puncture and catheter insertion may be repeated at the same or a different interspace which, however, carries the risk of a second dural puncture.
In 2013 we published a meta-analysis and found a significant reduction in the need for epidural blood patch (EBP), but not in the incidence of headache, from intrathecal catheterisation (ITC) after accidental dural puncture.7
This study updates the evidence by including relevant literature from the past five years. Moreover, we performed trial-sequential analyses (TSAs) that test for the presence or absence of sufficient evidence for the conclusions obtained with conventional meta-analytical methods. Recent investigations showed that conventional meta-analyses alone were often premature and bear the risk of false-positive results.8
Our meta-analysis followed the STROBE statement.9 The study was registered with PROSPERO (CRD42018118403). We performed a literature search on December 12th, 2018 in the databases PubMed, Google Scholar, Cochrane Library, Embase, Web of Science with the following search terms: (Spinal or intrathecal or subarachnoid) and (catheter or anaesthesia or analgesia) or continuous spinal and (Spinal or intrathecal or subarachnoid) and (catheter or anaesthesia or analgesia) and (Inadvertent or unintentional or accidental) dural puncture and postdural puncture headache or epidural blood patch. We also screened the bibliography of the retrieved articles for further relevant references. We aimed to be as inclusive as possible and therefore also included abstracts.
Studies were included according to the PICO acronym: P(atients): parturients scheduled for labour analgesia or anaesthesia for caesarean section; I(ntervention): inserting an intrathecal catheter upon observed accidental dural puncture; C(ontrol): epidural catheter re-site at the same or another interspace; O(utcomes): occurrence of PDPH, need for EBP. Additional secondary outcomes were the incidence of caesarean section in the labour analgesia studies, and side-effects.
The methodological quality of observational studies was assessed with the ROBINS-I tool10 and the quality of prospective randomised trials with the Cochrane risk of bias tool.11 Two researchers (MH, MK) independently screened the articles retrieved from the literature search for eligibility, and two researchers (MH, NH) performed the quality assessment and extracted the data (MH, CvdM).
Conventional meta-analysis: For the dichotomous outcomes (such as incidence of PDPH, need for EBP and incidence of caesarean section) risk ratios (RRs) and 95% confidence intervals (95%CI) were calculated. A condition for calculating pooled effect estimates was the presence of at least 100 patients per treatment arm and at least three studies. If there were more than two ITC groups, we combined the data of the groups by simple addition. We applied a random effects model. I2 statistics were computed to assess heterogeneity.
Trial-sequential analysis: Trial-sequential analysis is a statistical approach that allows the power of meta-analytical calculations to be assessed and it therefore controls for type I and II errors of statistical analysis. Details have been described previously.12 Briefly, a cumulative Z-curve (the Z-test value at each meta-analysis update), the conventional level of significance (e.g. Z-score=1.96 for a P-value threshold of 5%, independent of the quantity of evidence that has accumulated), the number of patients in the meta-analysis, the estimated required information size, and the trial sequential significance and futility boundaries are constructed. The TSA significance boundaries adjust the thresholds for significance and the risk of type 1 error is less than 5%. If the Z curve crosses the monitoring and futility boundaries, then there is sufficient evidence in the individual analyses.
Contour-enhanced funnel plots were performed if there were more than 10 studies. Plot asymmetry is an indicator of the existence of publication bias. We used the statistics programs RevMan for conventional meta-analysis, TSA software (version 0.9.5.10 Beta. Copenhagen Trial Unit, Copenhagen, Denmark) for TSA and R Studio version 1.0.136 for contour-enhanced funnel plots.
Section snippets
Results
Fig. 1 shows the flow chart with respect to selection of references. Of the 192 hits in our literature search (after removal of duplicates), 19 studies6, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30 were analysed. The abstract by Walters et al.19 was updated in a full paper in 201422 so in our analyses we included the data coming from the 2014 report.22 Similarly, the data published by Segal et al.30 were updated by Spiegel et al.16 and we included this latter data.
Discussion
Compared to our meta-analysis of 20137 we identified seven additional studies published since then, contributing data from an additional 1109 patients. The total number of patients in our analysis was 1653. Our conventional meta-analyses found statistically significant reductions in the incidence of PDPH and in the need for EBP in the ITC group. However, these findings were not corroborated in the respective TSAs.
While we were planning our study, a similar meta-analysis was published by Deng et
Declaration of interests
All authors have nothing to disclose.
Funding
Departmental funding only.
Acknowledgements
We would like to thank Ms. M. Gosteli, University Library, University of Zurich, Switzerland for her support with the systematic electronic literature search.
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2020, BJA EducationCitation Excerpt :Intrathecal catheters may potentially decrease the incidence of postdural puncture headache (PDPH) and need for epidural blood patch (EBP) compared with resiting the epidural catheter, as the ITC occludes the dural hole and prevents efflux of CSF. However, the evidence is conflicting; most available data come from retrospective studies and RCTs are lacking.3,4 The duration that the catheter remains in place postpartum or after dural puncture appears to influence the risk of PDPH and the need for EBP, as a longer duration may create inflammation that closes the dural hole.3