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* From the Departments of Anesthesia, and
Clinical Epidemiology Biostatistics, St. Josephs Healthcare and McMaster University, Hamilton, Ontario;
the Departments of Anesthesia and Health Policy, Management, and Evaluation, University Health Network, University of Toronto, Toronto, Ontario, Canada;
the Department of Anesthesia, University of Rochester, Rochester, New York, USA; and
* Foresight Links Corporation, London, Ontario, Canada.
Address correspondence to: Dr. Peter T. Choi, Department of Anesthesia, McMaster University, 1200 Main Street West, Room HSC-2U5, Hamilton, Ontario L8N 3Z5, Canada. E-mail: choip{at}mcmaster.ca
| Abstract |
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Methods: Citations on PDPH in the obstetrical population were identified by computerized searches, citation review, and hand searches of abstracts and conference proceedings. Citations were included if they contained extractable data on frequency, onset, or duration of PDPH. Using meta-analysis, we calculated pooled estimates of the frequency of accidental dural puncture for epidural needles and pooled estimates of the frequencies of PDPH for epidural and spinal needles.
Results: Parturients have approximately a 1.5% [95% confidence interval (CI) 1.5% to 1.5%) risk of accidental dural puncture with epidural insertion. Of these, approximately half (52.1%; 95% CI, 51.4% to 52.8%) will result in PDPH. The risk of PDPH from spinal needles diminishes with small diameter, atraumatic needles, but is still appreciable (Whitacre 27-gauge needle 1.7%; 95% CI, 1.6% to 1.8%). PDPH occurs as early as one day and as late as seven days after dural puncture and lasts 12 hr to seven days.
Conclusion: PDPH is a common complication for parturients undergoing neuraxial blockade.
| Introduction |
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The frequency, onset, and duration of PDPH have been evaluated by numerous researchers. Using meta-analysis, Halpern and Preston2 examined the influence of spinal needle design on the frequency of PDPH in all populations. Atraumatic needles and smaller diameter needles were associated with lower frequencies of PDPH compared to cutting needles and larger diameter needles respectively. The authors recommended that small diameter, atraumatic needles be used for spinal anesthesia. Onset and duration have been reported in a number of case series and comparative studies; however, commonly quoted figures for onset and duration are often based on data from mixed or non-obstetrical populations.
In this report, based on the existing research data from obstetrical populations, we present pooled estimates of accidental dural puncture (ADP) risk for epidural needles and PDPH risk for epidural and spinal needles and systematically review the literature on onset and duration of PDPH in this population. Our report extends the information provided by Halpern and Preston2 by providing percentages rather than odds ratios for PDPH frequency for both epidural and spinal needles and by reviewing the data on onset and duration of PDPH specific to the obstetrical population.
| Methods |
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Data extraction
Information on the intervention (epidural, spinal), needle design, co-interventions, the number and frequency of ADP (if epidural) and PDPH, and the duration and onset of PDPH were extracted from each citation by two independent reviewers. Disagreements were resolved by consensus.
Statistical analysis
In order to provide estimates of dural puncture (DP) and PDPH risk by needle type and size, combination of single-measurement proportions was necessary. We assumed that the studies would be heterogeneous and that between-study variance and within-study variance would both contribute to the total variance of the pooled event rate; therefore, a random effects model was chosen. Laird and Mosteller7 have described the statistics; calculations were performed using a Microsoft Excel 97 spreadsheet. Frequencies of events were reported with their 95% confidence intervals (CI). For studies with zero events, the upper 95% CI was calculated as described in Ho et al.8 Because DP and PDPH could be caused by either the epidural needle or the spinal needle when combined spinal epidural procedures are performed, events from combined spinal epidural procedures were examined separately from events caused by epidural or spinal needles.
Two sensitivity analyses were planned a priori. First, we compared estimates generated from retrospective vs prospective studies. Second, we compared estimates generated from RCT with those generated from all studies. These analyses were conducted when two or more studies contributed to each arm of the comparisons. The Z-statistic was used with P values calculated using SOLO Probability Calculator© (BMDP Statistical Software). A P value of less than 0.10 was considered significant.
A preliminary survey of the eligible studies suggested that quantitative pooling of data on onset and duration would be statistically difficult due to the variability in the reporting of temporal data. For onset, some authors reported the number of PDPH for each postpartum day; other authors reported the number of PDPH over a range of days. Most authors reported duration of PDPH as a range. Because of the wide differences in data presentation, we did not perform meta-analyses of onset or duration of PDPH but report our findings in a narrative fashion.
| Results |
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Methodological quality
Twenty-two RCT930 and 13 cohort studies3143 were evaluated (Table I
). There were no case-control studies. Inter-rater reliability was 0.58 and 0.68 for the Jadad scale and the Quality Index respectively. RCT had a median quality score of 2 (range 15) out of a maximum score of 5 on the Jadad scale. Cohort studies had a median quality score of 15 (range 520) out of a maximum score of 30 on the Quality Index.
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Only five needle groups ("all epidural needles", Hustead 18-G, Whitacre 25-G, Sprotte 24-G, and Quincke 25-G) had sufficient studies to undergo sensitivity analysis (Table III). We found statistically significant differences for "all epidural needles" in the ADP risk obtained from RCT compared to the risk obtained from all studies and for Whitacre 25-G needles and Sprotte 24-G needles in their PDPH risks obtained from prospective studies compared to the risk obtained from retrospective studies (Table II
). The estimates of risk obtained by RCT for the first case and prospective studies for the other two cases were higher than estimates of risk from all studies in the first case and from retrospective studies in the other two cases.
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Ten studies (three RCT,9,15,22 five cohort studies,32,34,3739 and two case series44,45) reported the duration of PDPH (Table A). No study reported data on the number of PDPH resolved by PDP day. Only one study45 reported the duration of PDPH after ADP from epidural needles. In the study by Holdcroft and colleagues, 13 of 1,000 patients experienced a PDPH, which lasted as long as six days.45 Treatment of PDPH was not reported. For spinal needles, the duration of PDPH ranged from one to seven days.15,22,32,34,3739,44 Further analysis of the data on onset and duration was not attempted as the data were confounded by differences in prophylactic and therapeutic interventions between studies and by uncertainty on the length of patient follow-up. Median patient follow-up was six days in the eight studies9,17,27,31,33,37,39,49 that reported length of follow-up along with data on onset or duration of PDPH. Length of follow-up was unclear in the other 12 studies.
| Discussion |
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Meta-analysis enabled the pooling of data to provide estimates of PDPH rates for different needle shapes and sizes. Previous meta-analyses2 on needle shapes and sizes have expressed results as odds ratios, which are difficult for clinicians and patients to interpret. Our meta-analyses provide numerical estimates of the risks of DP and PDPH (Figures 1
to 3
). With the exception of the "all epidural needles" group, the numbers of events, on which the DP and PDPH risks are calculated, are low for the various needle shapes and sizes despite pooling. Even with pooling of data from several studies, the CI for some estimates is large suggesting large differences in the PDPH rate between studies from which the pooled estimate was calculated. Meta-analyses with less than 200 outcome events, like the ones reported in this review, are considered "small" and should be interpreted with caution.61 Sensitivity analyses are performed to examine the robustness of the estimates. Statistical differences were seen in several analyses. In each case, prospective studies estimated higher risks than retrospective studies or all studies combined. This may suggest under-reporting in retrospective studies.
Further attention to the design and reporting of DP and PDPH is merited in future studies. Median quality scores for RCT (2/5) and cohort studies (15/30) were low. Suggestions for improvement have been reported previously.4
Attempts to determine the onset and duration of PDPH highlight the challenges and limitations of pooling data. Pooling requires data to be converted into discrete forms (e.g., proportions), continuous forms (e.g., means) or similar probabilities (e.g., P values). Conversion of the temporal data to forms amenable to meta-analysis was not possible in this study. Furthermore, the large variations in length of patient follow-up and in prophylactic and therapeutic interventions for PDPH limited the conclusions that we could make. Thus, we presented the information in a descriptive format.
Our pooled risk of DP is similar to risks reported previously.62 In contrast, the frequency of PDPH following ADP is lower than commonly quoted figures;6264 however, the number of reported events, on which we based our pooled estimates, are low. Additional reports of the PDPH risk in parturients receiving epidural analgesia or anesthesia would increase the precision of our pooled estimates. The PDPH risks observed with atraumatic and cutting spinal needles are consistent with previous reports62,63 and support the recommendations that the smallest diameter atraumatic needle should be used for spinal analgesia or anesthesia.2 We are unable to provide a pooled estimate of the PDPH risk with combined spinal epidural procedures based on current data.
Although we focused only on the obstetrical population, our observations on the onset and duration of PDPH are consistent with previous reviews, which were based on data from mixed populations. Although female sex and young age may be risk factors for development of PDPH, they are unlikely to affect the onset or duration of the complication. The size of the needle may also influence the onset and duration of PDPH. The heterogeneity of the published data precluded any quantitative analysis of this potential factor.
In general, the onset of PDPH will occur within the first seven days after a DP and lasts up to seven days. However, symptoms of PDPH can persist beyond this time. MacArthur and colleagues found that 17 of 74 parturients with ADP (23.0%; 95% CI, 14.9% to 33.7%) experienced symptoms for nine weeks to eight years (median 78 weeks).65 With the current trend towards shorter hospital stays after delivery, PDPH may not occur until the patient has been discharged (and no longer followed by the anesthesiologist). Patients and their caregivers (midwife, family physician, or obstetrician) need to be educated on the signs and symptoms of PDPH so that diagnosis and treatment occurs in a timely fashion.
How can we use these results?
When interpreting these results, we offer the following caveats. First, the pooled estimates in this meta-analysis are unadjusted for operator skill, which may be inversely related to DP risk. Most studies did not provide sufficient information to permit adjustment for operator skill. The risk of DP may be lower if we pooled data only from procedures performed by highly skilled operators.
Second, our estimates of PDPH risk are based on all PDPH. Due to the infrequent reporting of the severity of PDPH and the variation in the definitions used for severity, we did not estimate risks for mild, moderate, and severe PDPH. Knowledge of the risk for moderate or severe PDPH is useful for clinicians as these headaches frequently require treatment from anesthesiologists. We are not aware of any obstetrical study that has examined whether knowing the risk of PDPH vs knowing the risk of moderate or severe PDPH influences the patients decision to receive neuraxial analgesia or not.
Third, our estimates are based on studies of varying sample sizes with different complication rates. Whether the pooled estimates underestimate or overestimate the truth is controversial. On one hand, most studies evaluated less than 1,000 patients. These small studies tended to report high levels of risk or, less frequently, no risk compared to large studies. Thus, the pooled estimates may overestimate the true risk. However, this is unlikely, at least for DP risk, as the small studies contributed only 1.1% of the patients from which our pooled estimate is based. On the other hand, three of the seven large studies used a retrospective design, which may underestimate the frequencies of DP and PDPH.
How can we apply these results? We suggest that PDPH is generally a frequent complication. Parturients have approximately a 1 in 67 risk of an ADP during epidural insertion. Approximately half of all ADP will result in PDPH. With spinal needles, the risk of PDPH diminishes with smaller diameter, atraumatic needles, but the risk is still appreciable (e.g., a 1 in 59 risk for Whitacre 27-G needles). Most parturients with PDPH will experience the onset as early as one day and as late as seven days following DP. The complication usually lasts from one to seven days. For a hospital with 4,000 vaginal deliveries per year and an epidural rate of 60%, these risks translate into 36 ADP and 18 PDPH per year. If one assumes that one third of all PDPH will begin after two days postpartum and the average length of hospital stay will be two days, the diagnosis of PDPH will not be made in hospital in as many as six of the 18 patients.
These estimates should be interpreted within the context of other perioperative complications also. For example, the estimates are comparable to the frequency of perioperative myocardial infarction reported in prospective cohort studies of all consecutive patients undergoing non-cardiac surgery. In this context, the DP risk with epidural needles and the PDPH risk with spinal needles are still "low".
Finally, these estimates should not be interpreted dogmatically. For the individual clinician, his or her frequency of DP or PDPH will be influenced by other factors such as level of skill and time of day. Prospective follow-up of our own patients, ideally by another individual blinded to our intervention, can provide individualized risk estimates and trends over time.
| Acknowledgments |
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| Footnotes |
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Revision received February 12, 2003. Accepted for publication August 20, 2002.
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