Dural puncture epidural vs traditional epidural: A meta- analysis with trial sequential analysis of labor analgesia

doi:10.21203/rs.3.rs-3610314/v1

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Research Article

Dural puncture epidural vs traditional epidural: A meta- analysis with trial sequential analysis of labor analgesia

https://doi.org/10.21203/rs.3.rs-3610314/v1

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Purpose

Dural puncture epidural (DPE) is a modified version of traditional epidural (EPL) that is performed by puncturing the dura mater with a spinal needle without intrathecal drug administration. We performed an updated meta-analysis of randomized controlled trials with trial sequential analysis (TSA) to compare the benefits and risks of DPE with those of EPL for labor analgesia in parturients.

Methods

Web of Science, Embase, PubMed, and the Cochrane Library were searched from inception to March 2023. The meta-analysis was conducted using fixed- or random-effects models to estimate risk ratios and mean differences (MDs) with 95% confidence intervals (CIs). The reliability of the meta-analysis results was examined using TSA. The primary outcome was the time to adequate analgesia, defined as a pain score of ≤ 3/10 (or 30/100). The secondary outcomes were maternal delivery and neonatal outcomes, quality of analgesia, and adverse effects.

Results

Twelve studies involving 1,259 patients were included. Compared with EPL, DPE required 4 fewer minutes to achieve a pain score of ≤ 3/10 (or 30/100) (weighted MD − 3.99, 95% CI − 4.54 to − 3.44, I² (article heterogeneity) = 42%, p < 0.00001), and TSA confirmed these results. There were no significant differences in the secondary outcomes, except for the incidence of motor block. However, the TSA did not support all of the secondary outcomes.

Conclusion

Compared with EPL, DPE allowed faster relief of labor pain. There was no significant difference in the incidence of spontaneous and instrumental vaginal delivery, catheter adjustment and replacement, pruritus, post-dural puncture headache, or paresthesia between the two techniques.

analgesia

dural puncture epidural

labor

labor pain

Labor is a distressing experience that often exceeds a patient’s pain expectations. Neuraxial analgesia, which includes traditional epidural (EPL) analgesia, is a highly effective method for achieving pain relief during labor.¹ Methods of neuraxial analgesia have led to significant advancements in labor pain management. Although the caudal catheter-through-needle technique, known as traditional EPL, has minimal side effects, there is still room for improvement in terms of optimizing the onset of analgesia and motor block.²

In 1996, dural puncture epidural (DPE) analgesia was introduced.³ During DPE, a spinal needle is inserted into the epidural needle shaft, creating a single dural perforation. A catheter is then inserted into the epidural space through which analgesia or anesthesia is injected. The effectiveness of DPE has been compared to that of EPL for labor analgesia, with mixed results. Several studies have reported conflicting results regarding the effectiveness of DPE in providing analgesia during labor. Although some studies^4–10 have shown that DPE can provide rapid and effective pain relief without increasing the complication risk, others studies^11,12 have concluded that DPE does not improve the quality of epidural analgesia during labor. Two systematic reviews^13,14 reported that the benefits of DPE for labor analgesia are unclear due to the limited number of trials and methodological heterogeneity, making it difficult to perform data pooling. However, one meta-analysis¹⁵ reported that DPE is superior to EPL for the management of labor pain. It is important to note that these analyses were based on studies published several years ago. In recent years, two randomized controlled trials (RCTs)^16,17 have been published comparing DPE with EPL for labor analgesia. To provide an evidence-based foundation for clinical management, we conducted a meta-analysis and trial sequential analysis (TSA) to update the evidence on the benefits and risks of the DPE technique.

This study conformed to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement.¹⁸ The study was registered with the International Prospective Register of Systematic Reviews (No. CRD42020176667).

Search strategy

A systematic screening approach was used to identify relevant literature in Embase, Web of Science, PubMed, and the Cochrane library from their inception until March 2023. The search strategy included Medical Subject Headings and the following keywords: “analgesia”, “dural puncture epidural”, “labor”, and “labor pain”. The search strategy included additional terms listed in Supplementary Appendix A. Weekly alerts for primary screening queries from the National Library of Medicine were set up until May 1st, 2023, but no relevant results were found. Bibliographies of selected articles were also screened for eligible studies.

Study selection criteria

This study included RCTs that were peer-reviewed, with or without blinding. The inclusion criteria were 1) obstetric patients receiving neuraxial analgesia for labor pain; 2) DPE intervention; 3) traditional EPL analgesia as the comparator; 4) one or more of the following outcomes: analgesia onset, maternal delivery outcomes, neonatal outcomes, labor duration, block characteristics, and adverse effects, such as hypotension, pruritus, and post-dural puncture headache (PDPH); and 5) RCT design. The exclusion criteria were 1) studies including patients aged < 18 years and 2) studies with unavailable data. Non-English language articles were translated using an online translator.

Data extraction

Prior to commencing the review process, a standardized data extraction form was created by an independent reviewer (HBS). Subsequently, two authors (HBS and CHZ) independently extracted the required data from the enrolled articles, including the author names, publication year, country, number of patients, primary outcomes, intervention and comparator groups, and patient-controlled epidural analgesia component regimen. Any disagreements during data extraction were resolved by a third author (BZ).

Study quality assessment

Using the Cochrane risk-of-bias tool, two authors (HYS and YLB) independently assessed the selected studies for risk of bias and methodological quality.¹⁹ Seven domains were evaluated to determine the risk of bias, namely selective reporting, allocation concealment, participant and personnel blinding, outcome assessment blinding, incomplete outcome data, random sequence generation, and other biases. Each study was classified as having a low, high, or unclear risk of bias. Any disagreements were resolved by consensus with another author (BZ).

Statistical analysis

Review Manager Ver. 5.3 (Copenhagen, Nordic Cochrane Centre, Cochrane Collaboration, 2014) was used for data processing, while the TSA software package (Copenhagen Trial Unit, Copenhagen, Denmark) was used to conduct the TSA. We used the random-effects Mantel-Haenszel test to analyze dichotomous data. The results are presented as risk ratios (RRs) with 95% confidence intervals (CIs). Continuous variables are presented as the mean ± standard deviation and were analyzed using the weighted mean difference (WMD) to combine trials measuring the same outcome. A p value of ≤ 0.05 was considered statistically significant.

We used the I² test to assess article heterogeneity. If I² was < 50% and p was > 0.1, the heterogeneity among studies was considered small. In such cases, the fixed-effects model was used for analysis. Otherwise, the random-effects model was used for analysis. To test the robustness of the results, we conducted sensitivity analyses using the leave-one-out approach. To evaluate possible publication bias, we performed Egger's tests using Stata16.0 when more than 10 studies were included. A p value of > 0.05 indicated no significant publication bias.

Quality of evidence grading

The quality of evidence for outcomes was evaluated by two investigators (BZ and HYS) using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework. The GRADE framework classifies each outcome as having high, moderate, low, or very low quality of evidence based on certain factors, such as the risk of bias, inconsistency, indirectness, imprecision, and publication bias. The analysis was conducted using GRADE Pro version 3.2 software.

TSA

Traditional meta-analyses may be prone to type I error when only small amounts of data are available due to the possibility of random errors and repeated significance tests.²⁰ To address this issue, the TSA was used, which is a matrix meta-analysis approach that incorporates estimates of the required information size (RIS; the number of patients needed to detect a prespecified relative risk reduction).²¹ Additionally, TSA adjusts statistical significance thresholds to minimize the risk of erroneous conclusions when new studies are added to the meta-analysis. We used the TSA for all outcomes with a two-sided testing approach, a type I error rate of 5%, and a power of 90%. The O’Brien-Fleming method was used to establish boundaries to evaluate futility, inferiority, or superiority.²²

Search results

A total of 188 articles were identified by searching PubMed (n = 38), Embase (n = 56), Web of Science (n = 43), and the Cochrane library (n = 49), as well as performing manual bibliographic searches (n = 2). After removing duplicates, 102 articles were assessed for eligibility. Of these, 84 articles were excluded after reviewing their titles and abstracts. The full texts of the remaining 18 studies were reviewed, and 6 were excluded as they did not use EPL as the comparator or were non-RCTs, leaving 12 eligible RCTs for analysis.^{4–12,16,17,23} A PRISMA study flow diagram is shown in Fig. 1.

Study characteristics

Table 1 displays the features and outcomes of the included RCTs. These studies were published between 2005 and 2022 in five different countries and involved 1259 parturients, with 614 undergoing DPE and 645 undergoing EPL.

Risk-of-bias assessment

The quality of the studies was assessed using the Cochrane risk-of-bias tool. Of the 12 studies, eight^{4–7,10,12,17,23} were double-blinded and considered to be at a low risk of performance and detection bias. However, one study⁸ was single-blinded and was thus assigned a high risk of detection bias. Additionally, another study¹¹ excluded 23.4% of patients in the DPE group due to dural puncture failure, which led to a high risk of attrition bias. The risk-of-bias assessment results for each study are shown in Fig. 2.

Quality of evidence assessment

The meta-analysis results were assessed using the GRADE quality evidence framework. The findings showed that the mean time to adequate analgesia and the Apgar scores at the 1st minute, the incidence of fetal bradycardia, catheter adjustment, catheter replacement, nausea, motor block and unilateral sensory block were of a moderate quality evidence. The incidence of spontaneous and instrumental vaginal delivery, caesarean delivery, total and the second labor duration, additional bolus, hypotension, pruritus and PDPH were of a low quality of evidence. The incidence of paresthesia was found to have a very low quality of evidence (Table 2).

Primary outcome assessment

Time to adequate analgesia

Four studies^7,10,16,23 involving 368 patients (DPE: n = 185 and EPL: n = 183) identified a statistically significant difference in the median time taken to achieve adequate analgesia, defined as a pain score of ≤ 3/10 (or 30/100), after the initial epidural dose between DPE and EPL. Specifically, the time was 4 minutes shorter for DPE than for EPL (WMD − 3.99, 95% CI − 4.54 to − 3.44, I² = 42%, p < 0.00001) (Fig. 3A). Sensitivity analyses were conducted and the results remained robust, even after excluding any one of the four studies (Table 3).

The fixed-effects model was used to conduct the TSA with a type I error rate of 5% and a power of 90% using two-sided testing. The RIS for both the experimental and control groups was calculated based on the included data using TSA estimation. The RIS was set to the expected information value. The results showed that the cumulative Z value of the time to adequate analgesia crossed the RIS threshold and the boundary lines, providing conclusive evidence based on the amount of available information (Fig. 3B).

Secondary outcome assessment

Maternal delivery outcomes

Ten studies^{4–9,12,16,17,23} involving 1,089 patients (DPE: n = 537 and EPL: n = 552) were analyzed with the fixed-effects model to assess the incidence of spontaneous vaginal delivery. The rate of spontaneous vaginal delivery in the DPE group was comparable to the EPL group, with no significant difference between the two groups (RR 1.02, 95% CI 0.96–1.09, I² = 0%, p = 0.48) (Fig. 4A). The TSA results showed that the cumulative Z-value for the spontaneous vaginal delivery rate crossed the RIS threshold and the boundary lines, providing conclusive evidence based on the amount of available information (Fig. 4B). Egger’s test yielded a p value of 0.3183, indicating the absence of publication bias.

The same 10 studies^{4–9,12,16,17,23} were analyzed with the fixed-effects model to assess the rate of instrumental vaginal delivery. The incidence of instrumental vaginal delivery in the DPE group was comparable to the EPL group (RR 1.01, 95% CI 0.71–1.44, I² = 0%, p = 0.95) (Fig. 4C). The cumulative Z-value crossed the RIS threshold and the boundary lines, providing conclusive evidence based on the amount of available information (Fig. 4D). Egger’s test yielded a p value of 0.3310, indicating the absence of publication bias.

Eleven studies^{4–9,11,12,16,17,23} involving 1,201 patients (DPE: n = 586 and EPL: n = 615) were analyzed with the fixed-effects model to assess the incidence of cesarean delivery. The rate of caesarean delivery in the DPE group was comparable to the EPL group (RR 0.90, 95% CI 0.71–1.15, I² = 0%, p = 0.41) (Fig. 4E). The cumulative Z-value did not exceed the RIS threshold or the boundary lines. Therefore, additional studies are needed to demonstrate the safety endpoint (Fig. 4F). Egger’s test yielded a p value of 0.3579, indicating the absence of publication bias.

Four studies^12,16,17,23 involving 470 patients (DPE: n = 228 and EPL: n = 242) were analyzed with the fixed-effects model to assess the total labor duration. The total labor duration in the DPE group was comparable to the EPL group (WMD 5.72, 95% CI − 24.02 to 35.46, I² = 0%, p = 0.71) (Fig. 4G). The cumulative Z-value did not reach either the RIS threshold or the boundary lines, indicating that the amount of available information was insufficient (Fig. 4H). Therefore, further research is needed to draw conclusive results.

Four studies^4,9,17,23 involving 379 patients (DPE: n = 192; EPL: n = 187) were analyzed with the fixed-effects model to assess the duration of the second stage of labor. The duration of the second stage of labor in the DPE group was comparable to the EPL group (WMD 3.14, 95% CI − 0.70 to 6.97, I² = 19%, p = 0.11) (Fig. 4I). The cumulative Z-value did not reach either the RIS or the boundary lines, indicating that the amount of available information was insufficient to reach definitive conclusions (Fig. 4J).

Neonatal outcome assessment

Six studies^{5,7,9,16,17,23} involving 619 patients (DPE: n = 310; EPL: n = 309) were analyzed with the fixed-effects model to assess the Apgar scores at the 1st minute. The results showed that Apgar scores at 1st minute in the DPE group was comparable with that in the EPL group (WMD = 0.02, 95% CI: -0.12 to 0.15, I² = 0%, p = 0.81) (Fig. 5A). The TSA showed that the cumulative Z-value did not reach either the RIS threshold or the boundary lines, indicating that the amount of information was insufficient, and further studies are needed to reach conclusive results (Fig. 5B).

Seven studies^{4,6–9,17,23} involving 750 patients (DPE: n = 376; EPL: n = 374), were analyzed with the fixed-effects model to assess the incidence of fetal bradycardia. The results showed that the incidence of fetal bradycardia in the DPE group was comparable to the EPL group (RR 0.90, 95% CI 0.59–1.39, I² = 0%, p = 0.65) (Fig. 5C). The cumulative Z-value did not exceed the RIS threshold or the boundary lines (Fig. 5D). This suggests that the available information was insufficient, and further research is thus needed to draw conclusive results.

Quality of analgesia assessment

Four studies^5,6,12,17 involving 521 patients (DPE: n = 252; EPL: n = 269) were analyzed with the fixed-effects model to assess the incidence of catheter adjustment. The incidence of catheter adjustment in the DPE group was comparable to the EPL group (RR 1.04, 95% CI 0.76–1.43, I² = 45%, p = 0.80) (Fig. 6A). The cumulative Z-value did not exceed the RIS or the boundary lines (Fig. 6B), suggesting that the available information was insufficient, and further research is needed to draw conclusive results.

The same four studies^5,6,12,17 were analyzed to assess the incidence of catheter replacement. The incidence of catheter replacement in the DPE group was comparable to the EPL group (RR 0.76, 95% CI 0.40–1.47, I² = 21%, p = 0.42) (Fig. 6C). The cumulative Z-value exceeded the RIS threshold, suggesting that the available information was sufficient to draw conclusive results (Fig. 6D).

Six studies^{4,6–8,17,23} involving 750 patients (DPE: n = 326; EPL: n = 324) were analyzed with the fixed-effects model to assess the incidence of motor block. The results showed that the incidence of motor block in the DPE group was lower than in the EPL group (RR 0.65, 95% CI 0.42–0.99, I² = 14%, p = 0.04) (Fig. 6E). The cumulative Z-value did not exceed the RIS or the boundary lines (Fig. 6F). This suggests that the available information was insufficient, and further research is needed to draw conclusive results.

Five studies^5–8,12 involving 669 patients (DPE: n = 326; EPL: n = 343) were analyzed with the fixed-effects model to assess the incidence of unilateral sensory block. The incidence of unilateral sensory block in the DPE group was comparable to the EPL group (RR 0.86, 95% CI 0.65–1.12, I² = 28%, p = 0.26) (Fig. 6G). The cumulative Z-value crossed the RIS threshold, suggesting that the amount of available information provided conclusive results (Fig. 6H).

Seven studies^4–8,11,23 involving 709 patients (DPE: n = 348; EPL: n = 361) were analyzed with the fixed-effects model to assess the incidence of additional bolus. The incidence of additional bolus in the DPE group was comparable to the EPL group (RR 0.92, 95% CI 0.70–1.21, I² = 49%, p = 0.57) (Fig. 6I). The cumulative Z-value did not exceed the RIS or the boundary lines (Fig. 6J), suggesting that the available information was insufficient. Therefore, further research is needed to draw conclusive results.

Adverse effects assessment

Eight studies^{4,6–8,11,12,17,23} involving 990 patients (DPE: n = 482; EPL: n = 510) were analyzed with the fixed-effects model to assess the incidence of hypotension. The incidence of hypotension in the DPE group was comparable to the EPL group (RR 0.92, 95% CI 0.67–1.27, I² = 0%, p = 0.61) (Fig. 7A). The cumulative Z-value did not exceed the RIS or the boundary lines (Fig. 7B). Therefore, the available information was insufficient, and further research is needed to draw conclusive results.

Six studies,^{4,6,9,16,17,23} involving 500 patients (DPE: n = 251; EPL: n = 249) were analyzed with the fixed-effects model to assess the incidence of nausea. The incidence of nausea in the DPE group was comparable to the EPL group (RR 0.71, 95% CI 0.39–1.27, I² = 0%, p = 0.24) (Fig. 7C). The cumulative Z-value did not exceed the RIS or the boundary lines (Fig. 7D). Therefore, further research is needed to draw conclusive results.

Eight studies^{4,6–9,16,17,23} involving 500 patients (DPE: n = 391; EPL: n = 249) were analyzed with the fixed-effects model to assess the incidence of pruritus. The incidence of pruritus in the DPE group was comparable to the EPL group (RR 0.91, 95% CI 0.65–1.27, I² = 0%, p = 0.57) (Fig. 7E). The cumulative Z-value did not exceed the RIS, but it did exceed the boundary lines (Fig. 7F). Therefore, the available information was sufficient to reach conclusive results.

Six studies^{6–8,11,17,23} involving 682 patients (DPE: n = 335; EPL: n = 347) were analyzed with the fixed-effects model to assess the incidence of PDPH. The incidence of PDPH in the DPE group was comparable to the EPL group (RR 1.54, 95% CI 0.40–5.87, I² = 21%, p = 0.53) (Fig. 7G). The cumulative Z-value did not exceed the RIS, but it did exceed the boundary lines (Fig. 7H), again suggesting that the available information was sufficient to provide conclusive results.

Three studies^8,11,12 involving 422 patients (DPE: n = 196; EPL: n = 226) were analyzed with the random-effects model to assess the incidence of paresthesia. The results showed that the incidence of paresthesia in the DPE group was comparable to the EPL group (RR 4.10, 95% CI 0.25–66.92, I² = 87%, p = 0.32) (Fig. 7I). The cumulative Z-value did not exceed the RIS, but it did exceed the boundary lines (Fig. 7J), suggesting that the available information was sufficient to provide conclusive results.

This meta-analysis included 12 RCTs and systematically assessed the impact of DPE on the quality and safety of analgesia, maternal–neonatal outcomes, and labor duration during labor pain treatment. DPE achieved adequate analgesia within a shorter duration than EPL (average of 3.99 minutes shorter than EPL). DPE demonstrated a lower incidence of motor block than EPL, while the remaining outcomes were not significantly different between the two techniques. The TSA confirmed that the primary outcome and some of the secondary outcomes, including the incidence of spontaneous and instrumental vaginal delivery, catheter adjustment and replacement, pruritus, PDPH, and paresthesia, were tested in a sufficiently large sample size to ensure the reliability of the results. However, further investigation is required to verify the results of the other secondary outcomes, including the incidence of cesarean delivery, motor block, unilateral sensory block, hypotension, nausea, total and second-stage labor duration, and neonatal outcomes. The GRADE evidence quality rating indicated that most of the outcomes had a low-to-moderate quality of evidence, with the exception of the incidence of paresthesia, which had a very low quality of evidence. These findings suggest that the results may not be reliable.

Previous reviews^13,14 examining the benefits of DPE for labor analgesia were inconclusive and failed to combine data to account for potential methodological differences. A recent meta-analysis¹⁵ found that DPE was more effective than EPL for relieving labor pain by reducing the time needed to achieve satisfactory pain control, and it was without any adverse effects on the mother or fetus. However, the meta-analysis used the GRADE framework only to evaluate the quality of evidence for the primary outcome; it did not conduct TSA. In recent years, the evidence base has been expanded by two additional RCTs.^16,17 Our meta-analysis included 12 RCTs and provided an update to the existing literature. We evaluated the quality of all of the outcome indicators using the GRADE framework and performed TSA on each indicator.

DPE anesthesia uses a spinal needle to puncture the dura mater without administering intrathecal medication. The advantage of this technique is the clear endpoint of cerebrospinal fluid return through the spinal needle.²⁴ We confirmed that DPE leads to a faster onset of analgesia, which is consistent with previous reviews.^13–15 A previous study showed that local anesthetic leakage through dural holes is associated with the spinal needle diameter or type.²⁵ The RCTs included in this meta-analysis generated dural holes with different diameter spinal needles, including 25-,^{4–7,11,17,23} 26-,⁸ or 27-gauge needles.^9,10,12,16 Spinal needles of different diameters can form varied hole sizes after puncturing the spinal membrane. Larger holes may facilitate better diffusion of local anesthetics through the meninges.²⁶ Nonetheless, the mechanisms influencing dural drug diffusion are complex and are not solely dependent on hole diameter. Anesthetic penetration into the spinal dura is influenced by several factors, such as the penetration capacity of the drug; the pressure difference between the epidural and subarachnoid spaces; and the type, volume, and concentration of the administered anesthetic.^27–29 The studies analyzed in this meta-analysis utilized epidurals containing a combination of local anesthetics, such as bupivacaine or ropivacaine, along with opioid narcotics, such as sufentanil or fentanyl. However, it is important to note that the studies varied in their approach and methodology. Thus, to reduce clinical and methodological heterogeneity, further research is needed to determine the interactions between variables affecting anesthetic penetration through the spinal dura.

The present study has some limitations that should be noted. First, the quality of the included trials was relatively low. Figure 2 illustrates that although most of the trials adequately reported the methodologies used, several domains still received an “unclear” rating due to insufficient information in their studies. Second, due to the limited number of included trials, we were unable to detect publication bias for most of the outcomes, which inevitably affected the precision of our findings. Third, the meta-analysis detected significant methodological heterogeneity between the studies, which may have affected the validity of the results. Despite being the largest study conducted on the topic, the sample size was still not sufficient. The second outcome indicators showed no significant difference between DPE and EPL, except for the incidence of motor block. It is important to note that most of the available information did not reach the RIS. Therefore, further trials are needed to establish the credibility of the conclusions.

DPE has a shorter analgesic onset time (on average 3.99 minutes shorter) than traditional EPL. However, although statistically significant, this difference may not have clinical relevance. Further research is needed to determine the effects of the two analgesic techniques for labor pain relief on various factors, such as the incidence of cesarean delivery, motor block, unilateral sensory block, hypotension, nausea, total and second-stage labor duration, and neonatal outcomes.

DPE

dural puncture epidural

EPL

traditional epidural analgesia

total number of events

total number of samples

not applicable

GRADE

Grading of Recommendations Assessment,Development and Evaluation

PDPH: postdural puncture headache.

Acknowledgments

The authors acknowledge TopEdit LLC for the linguistic editing and proofreading during the preparation of this manuscript.

Authors’ contributions

HBS and BZ independently evaluated the title, abstract, and full text of each identified article. YLB and CHZ created figures and tables. All authors contributed to the article and approved the submitted version.

Funding

This study is funded by the Zhejiang Provincial Medical and Health Science and Technology Project of China (Grant Numbers 2021KY259).

Availability of data and materials

The original contributions presented in the study are included in the article/supplementary material, further inquiries can be directed to the corresponding author.

Ethics approval and consent to participate

Not applicable.

Consent for publication

Not applicable.

Competing interests

All authors declare that they have no conflicts of interest.

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Table 1 Summary of RCTs investigating DPE for labor

Authors yr	Country	Design	DPE group		Epidural group		Injections	Primary Outcome
Authors yr	Country	Design	Sample size	Intervention	Sample size	Intervention	Injections	Primary Outcome
Eric Cappiello 2008	USA	RCT 2 arms	39	Dural puncture with 25-G Whitacre spinal needle	40	17-G Weiss epidural needle, 20-G multiport polyamide catheter advanced 5 cm	Initial dosing: 12 mL bupivacaine 2.5 mg/mL over 5 min PCEA: bupivacaine 1.25 mg/mL + fentanyl 0.2 µg/mL, 6 mL/h, PCA 6 mL/15min, and no hourly limits	The presence of sacral dermatome (S1) blockade and a VAS analgesia score of < 10 within 20 min of epidural analgesia initiation
Anthony Chau 2017	Canada	RCT 3 arms	40	Dural puncture with 25-G Whitacre spinal needle	40	L2-L3 or L3-L4, 17-G Weiss epidural needle 19-G multiport polyamide catheter advanced 5cm	Initial dosing: 20 mL 0.125% bupivacaine + fentanyl 2 µg/mL fractionated into four 5-mL boluses given over 5 minutes PCEA: bupivacaine 1.25 mg/mL + fentanyl 2µg/mL, 6 mL/h, PCA: 6 mL/15 min, hourly limit of 20 mL	Time to NPRS score ≤ 1
Authors yr	Country	Design	DPE group		Epidural group		Injections	Primary Outcome
Authors yr	Country	Design	Sample size	Intervention	Sample size	Intervention	Injections	Primary Outcome
Ashok Jadon 2019	India	RCT 2 arms	15	27-G Whitacre pencil-point needle	15	L3~L4, 18-G Tuohy needle, 19-G epidural catheter	Initial dose：12mL 0.125% bupivacaine PCEA: 0.08% bupivacaine and fentanyl 1.66 µg/mL, 10 mL/h Rescue analgesia for breakthrough pain: 0.125% bupivacaine 5 mL	Time to achieve a reduction in VAS > 50%, time to achieve VAS ≤ 3
Jing Wang 2021	China	RCT 2 arms	100	25-G Whitacre needle	100	L3-L4, 17-G epidural needle, 19-G epidural catheter advanced 4 cm	Test dose: 3mL 1.5% lidocaine with 15 µg of epinephrine Initial dosing: 10 mL of 0.08% ropivacaine with 0.4 µg/mL sufentanil PCEA: 0.08% ropivacaine with 0.4 µg/mL sufentanil, 10mL/h PCA: 5mL with a 20-minute lockout Rescue analgesia for breakthrough pain: 5mL 0.2% ropivacaine with a further 5 mL after a 10-minute interval	The percentage of participants in the two groups with VAS score ≤ 30 mm 10 minutes after the initiation of the epidural bolus
Authors yr	Country	Design	DPE group		Epidural group		Injections	Primary Outcome
Authors yr	Country	Design	Sample size	Intervention	Sample size	Intervention	Injections	Primary Outcome
Sylvia H. Wilson 2018	USA	RCT 2 arms	40	Dural puncture with 26-G Whitacre needle	40	L3-L4 or L4-L5 17-G epidural needle, 19-G multiport polyamide catheter advanced 4 to 5 cm	Test dose: 3 mL 1.5% lidocaine with epinephrine 5 µg/mL Initial dosing: 12mL 0.125% bupivacaine with 50 µg fentanyl in 4-mL aliquots administered every minute over 3 minutes PCEA: 0.1% bupivacaine with 2 µg/mL fentanyl at 10 mL/h PCA: 5 mL /10 minutes; 32 mL/h maximum	The percentage of parturients in each group with VAS score ≤ 10 mm (0 to 100) 10 minutes after epidural bolus initiation
Yujie Song 2021	China	RCT 3 arms	38	Dural puncture with 25-G Whitacre needle	38	L2-L3 or L3-L4 17-G Tuohy needle, 19-G multi-orifice stainless steel impregnated epidural catheter advanced 4 cm	Test dose: 3 mL of 1.5% lidocaine with 15 µg epinephrine Initial dosing: 10 mL 0.1% ropivacaine with 0.3µg/mL sufentanil over 2 minutes PCEA: 0.1% ropivacaine with 0.3 µg/mL sufentanil, 8 mL/h, PCA: 5 mL with a 20-minute lockout Breakthrough Pain Management: 5 mL of 0.125% ropivacaine (continued on next page)	Time to VAS score ≤ 30 mm (0 to 100)
Authors yr	Country	Design	DPE group		Epidural group		Injections	Primary Outcome
Authors yr	Country	Design	Sample size	Intervention	Sample size	Intervention	Injections	Primary Outcome
Pritam Yadav 2018	India	RCT 2 arms	30	Dural puncture with 27-G Whitacre needle	30	L3-4 16-G Tuohy needle, 18‑G multiorifice catheter advanced 5 cm	Initial dose: 10mL 0.2% ropivacaine with 2 µg/mL fentanyl An additional 10 ml of study medication was administered in case adequate analgesia (VAS score ≤ 3) was not achieved after duration of 15 min from first bolus dose	VAS score
John A. Thomas 2005	USA	RCT 2 arms	107	Dural puncture with 27-G Whitacre spinal needle	123	L3-L4 or L4-L5 17-G Weiss epidural needle, 19-G multiport epidural catheter advanced 4-6 cm	Test dose: 2 + 5 mL 2% lidocaine Initial dose: 3 mL 2% lidocaine PCEA: 0.11% bupivacaine and 2 µg/mL fentanyl 10 mL/h, PCA: 5mL/10min, hourly limit of 30 mL	Epidural catheter manipulation rate
Wahba Z. Bakhet 2021	Egypt	RCT 3 arms	40	25-G Whitacre spinal needle	40	L3‑L4 or L4‑L5 18‑G Tuohy needle, 20‑G multi‑orifice epidural catheter	Initial dose: 10mL 0.1% bupivacaine with 2 µg/mL fentanyl, in two incremental boluses of 5 mL given over 5 min PCEA: 0.1% bupivacaine with 2 µg/mL fentanyl 8mL/h PCA: 5mL/15min	The mean hourly consumption of epidural local anesthetic

Authors

Country

Design

DPE group

Epidural group

Injections

Primary Outcome

Sample

size

Intervention

Sample size

Intervention

Hon Sen Tan

2022

USA

RCT

2 arms

25-G Whitacre needle

L3-4 or L4-L5
17-G Tuohy needle,
19-G Duraflex wire-reinforced multiport catheter

Initial dosing: 0.1% ropivacaine with 2 µg/mL fentanyl 15 mL over 6 min

PCEA: 0.1% ropivacaine with 2 µg/mL fentanyl 6mL/ 45min

PCA: 8mL/10min

Asymmetrical block, epidural top-ups, catheter adjustments, catheter replacement, conversion to cesarean delivery

Deepak

Gupta

2013

USA

RCT

2 arms

Dural puncture with 25-G Pencan needle

L2-L3 or L3-L4，
17-G Tuohy needle,

19-G multiport polyamide catheter advanced 5cm

Test dose: 3 mL 1.5% lidocaine with 1:200,000 epinephrine
Initial dosing: 0.125% bupivacaine +10µg/mL fentanyl in two incremental doses of 5 mL each
Infusion: 10 mL/h 0.125% bupivacaine + 2.5 µg/mL fentanyl

Intra-procedure characteristics,
early or delayed complications

Authors

Country

Design

DPE group

Epidural group

Injections

Primary Outcome

Sample

size

Intervention

Sample size

Intervention

Yuanyuan

2020

China

RCT

2 arms

Dural puncture

with 27-G needle

L2~L3 or L3~L4,
polyamide catheter advanced 4cm

Test dose：3 mL 1.5% lidocaine with 1: 200000 epinephrine
Initial dose: 10mL 0.1% ropivacaine with 0.25 µg ∕ mL sufentanil
PCEA: 0.1% ropivacaine with 0.25 µg ∕ mL sufentanil 8 mL/h

PCA: 8 mL/ 15 min

VAS scores

DPE = dural puncture epidural; G = gauge; L = lumbar vertebra; NPRS = numerical pain rating scale; VAS = visual analog scale;

PCEA = patient-controlled epidural analgesia; PCA= patient-controlled analgesia; RCT = randomized controlled trial;

PIEB = programmed intermittent epidural boluses.

Table 2 is available in the Supplementary Files section.

Table 3

Sensitivity analysis for the time to adequate analgesia (omitting a single RCT)
	MD* (95% CI)	P-value for MD*	I² (%)	P-value for I²
All studies	-3.99 (-4.54 to -3.44)	< 0.00001	42	0.16
Selected study omitted
Yujie Song, 2021²³ Jing Wang, 2021⁷ Pritam Yadav, 2018¹⁰ Ashok Jadon, 2021¹⁶	-4.01 (-4.55 to -3.46) -3.96 (-4.98 to -2.95) -4.15 (-4.72 to -3.58) -3.80 (-4.40 to -3.19)	< 0.00001 < 0.00001 < 0.00001 < 0.00001	58 62 0 37	0.09 0.07 0.42 0.20
RCT = randomized controlled trial, MD = mean difference, CI = confidence interval;
*Calculated as mean of intervention group-mean of control group.

No competing interests reported.

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Dural puncture epidural vs traditional epidural: A meta- analysis with trial sequential analysis of labor analgesia

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Time to adequate analgesia

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