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Bolus mandatori automatik berbanding infusi basal untuk mengekalkan analgesia epidural semasa bersalin

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Background

Epidural analgesia is often used for pain relief during labour and childbirth, and involves administration of local anaesthetics (LA) into the epidural space resulting in sensory blockade of the abdomen, pelvis, and perineum. Epidural opioids are often co‐administered to improve analgesia. Administration of epidural medications can be accomplished by basal infusion (BI) or automated mandatory bolus (AMB). With BI, medications are administered continuously, while AMB involves injecting medications at set time intervals. Patient‐controlled epidural analgesia (PCEA) on top of AMB or BI enables patients to initiate additional boluses of epidural medications. 

The superior method of delivering epidural medications would result in lower incidence of pain requiring anaesthesiologist intervention (breakthrough pain). Also, it should be associated with lower incidence of epidural‐related adverse effects including caesarean delivery, instrumental delivery (use of forceps or vacuum devices), prolonged duration of labour analgesia, and LA consumption. However, clear evidence of the superiority of one technique over the other is lacking. Also, differences in the initiation of epidural analgesia such as combined spinal‐epidural (CSE) (medications given into the intrathecal space in addition to the epidural space) compared to epidural only, and medications used (types and doses of LA or opioids) may not have been accounted for in previous reviews. 

Our prior systematic review suggested that AMB reduces the incidence of breakthrough pain compared to BI with no significant difference in the incidence of caesarean delivery or instrumental delivery, duration of labour analgesia, and LA consumption. However, several studies comparing AMB and BI have been performed since then, and inclusion of their data may improve the precision of our effect estimates.

Objectives

To assess the benefits and harms of AMB versus BI for maintaining labour epidural analgesia in women at term.

Search methods

We searched CENTRAL, Wiley Cochrane Library), MEDLINE, (National Library of Medicine), Embase(Elseiver), Web of Science (Clarivate), the WHO‐ICTRP (World Health Organization) and ClinicalTrials.gov (National Library of Medicine) on 31 December 2022. Additionally, we screened the reference lists of relevant trials and reviews for eligible citations, and we contacted authors of included studies to identify unpublished research and ongoing trials.

Selection criteria

We included all randomised controlled studies that compared bolus dosing AMB with continuous BI during epidural analgesia. We excluded studies of women in preterm labour, with multiple pregnancies, with fetal malposition, intrathecal catheters, those that did not use automated delivery of medications, and those where AMB and BI were combined.

Data collection and analysis

We used standard methodology for systematic review and meta‐analysis described by Cochrane. Primary outcomes included: incidence of breakthrough pain requiring anaesthesiologist intervention; incidence of caesarean delivery; and incidence of instrumental delivery. Secondly, we assessed the duration of labour; hourly LA consumption in bupivacaine equivalents, maternal satisfaction after fetal delivery, and neonatal Apgar scores. 

The following subgroup analyses were chosen a priori: epidural alone versus CSE technique; regimens that used PCEA versus those that did not; and nulliparous versus combination of nulli‐ and multi‐parous women.

We used the GRADE system to assess the certainty of evidence associated with our outcome measures.

Main results

We included 18 studies of 4590 women, of which 13 enrolled healthy nulliparous women and five included healthy nulli‐ and multiparous women. All studies excluded women with preterm or complicated pregnancies. Techniques used to initiate epidural analgesia differed between the studies: seven used combined spinal epidural, 10 used epidural, and one used dural puncture epidural (DPE). There was also variation in analgesics used. Eight studies utilised ropivacaine with fentanyl, three used ropivacaine with sufentanil, two utilised levobupivacaine with sufentanil, one used levobupivacaine with fentanyl, and four utilised bupivacaine with fentanyl. Most of the studies were assessed to have low risk of randomisation, blinding, attrition, and reporting biases, except for allocation concealment where eight studies were assessed to have uncertain risk and three with high risk.

Our results showed that AMB was associated with lower incidence of breakthrough pain compared to BI (risk ratio (RR) 0.71; 95% confidence interval (CI) 0.55 to 0.91; I2 = 57%) (16 studies, 1528 participants), and lower hourly LA consumption in bupivacaine equivalents (mean difference (MD) ‐0.84 mg/h; 95% CI ‐1.29 to ‐0.38, I2 = 87%) (16 studies, 1642 participants), both with moderate certainty. AMB was associated with an estimated reduction in breakthrough pain incidence of 29.1% (incidence 202 per 1000, 95% CI 157 to 259), and was therefore considered clinically significant.

The incidence of caesarean delivery (RR 0.85; 95% CI 0.69 to 1.06; I2 = 0%) (16 studies, 1735 participants) and instrumental delivery (RR 0.85; 95% CI 0.71 to 1.01; I2 = 0%) (17 studies, 4550 participants) were not significantly, both with moderate certainty. There was no significant difference in duration of labour analgesia (MD ‐8.81 min; 95% CI ‐19.38 to 1.77; I2 = 50%) (17 studies, 4544 participants) with moderate certainty. Due to differences in the methods and timing of outcome measurements, we did not pool data for maternal satisfaction and Apgar scores. Results reported narratively suggest AMB may be associated with increased maternal satisfaction (eight studies reported increased satisfaction and six reported no difference), and all studies showed no difference in Apgar scores.

WIth the exception of epidural alone versus CSE which found significant subgroup differences in LA consumption between AMB and BI, no significant differences were detected in the remaining subgroup analyses.

Authors' conclusions

Overall, AMB is associated with lower incidence of breakthrough pain, reduced LA consumption, and may improve maternal satisfaction. There were no significant differences between AMB and BI in the incidence of caesarean delivery, instrumental delivery, duration of labour analgesia, and Apgar scores. Larger studies assessing the incidence of caesarean and instrumental delivery are required.

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Adakah bolus mandatori automatik ubat epidural memberikan kelegaan sakit bersalin yang lebih baik daripada infusi basal?

Mesej utama

‐ Apabila digunakan untuk mengekalkan kelegaan dari sakit epidural semasa bersalin, bolus mandatori automatik dikaitkan dengan kejadian sakit yang lebih rendah yang memerlukan intervensi klinikal dan penggunaan ubat, berbanding infusi basal.

‐ Kedua‐dua bolus mandatori automatik dan infusi basal adalah setanding dalam kejadian bersalin secara caesarean, bersalin dengan bantuan alat, dan tempoh epidural bersalin.

Apakah kaedah‐kaedah untuk mengekalkan kelegaan dari sakit epidural semasa bersalin?

Epidural sering digunakan untuk melegakan kesakitan semasa bersalin, dan melibatkan pemberian ubat anestetik setempat ke dalam ruang epidural di sekitar tulang belakang. Secara umumnya, ubat boleh dihantar melalui dua teknik: infusi basal (BI) dan bolus mandatori automatik (AMB). Dengan BI, ubat diberikan tanpa gangguan dalam tempoh masa yang panjang, manakala AMB melibatkan pemberian ubat pada selang masa yang ditetapkan dengan setiap dos dihantar dalam tempoh masa yang singkat.

Kaedah penghantaran ubat epidural yang unggul akan menghasilkan kelegaan dari sakit yang berkesan dan kurang kejadian mengalami kesakitan yang memerlukan intervensi pakar anestesi (juga dipanggil kesakitan terobosan). Juga, ia akan dikaitkan dengan kurang kejadian kesan buruk berkaitan epidural termasuk bersalin secara caesar, bersalin dengan bantuan (penggunaan forsep atau alat vakum untuk membantu melahirkan), tempoh kelegaan sakit bersalin yang berpanjangan, dan peningkatan penggunaan anestetik setempat.

Apa yang kami ingin ketahui?

Kajian terdahulu telah melaporkan data yang bercanggah mengenai kaedah mana (AMB berbanding BI) memberikan kelegaan kesakitan yang unggul semasa bersalin, dan ulasan sistematik sebelum ini sudah lapuk kerana terdapat beberapa kajian baharu yang diterbitkan mengenai topik ini. Kemasukan data mereka boleh meningkatkan ketepatan keputusan kami mengenai keberkesanan dan potensi kesan buruk AMB berbanding BI untuk mengekalkan kelegaan sakit epidural semasa bersalin. 

Oleh itu, kami berhasrat untuk membandingkan AMB dengan BI dari segi:

‐ kejadian kesakitan terobosan (sakit yang berlaku semasa epidural bersalin yang memerlukan intervensi pakar anestesi)

‐ kejadian bersalin secara caesar

‐ kejadian bersalin dengan bantuan alat

Selain itu, kami membandingkan AMB dengan BI dari segi tempoh analgesia epidural dan penggunaan anestetik setempat.

Apa yang kami lakukan?

Kami mencari kajian yang membandingkan AMB dengan BI untuk melegakan kesakitan epidural bersalin. Kami membandingkan dan merumuskan keputusan kajian ini dan menilai keyakinan kami terhadap bukti berdasarkan faktor seperti kaedah dan saiz kajian.

Apakah yang telah kami dapati?

Ulasan kami memasukkan 18 kajian yang melibatkan 4590 wanita dengan kehamilan yang tidak rumit. Secara keseluruhan, kami mendapati bahawa AMB dikaitkan dengan kurang kejadian kesakitan terobosan dan kurang penggunaan anestetik setempat berbanding BI, tetapi kedua‐dua kaedah adalah setanding mengenai kejadian bersalin secara caesar, bersalin dengan bantuan alat, dan tempoh epidural bersalin.

Apakah batasan bukti?

Kami mempunyai keyakinan sederhana terhadap bukti, tetapi ia dihadkan oleh dua faktor utama. Pertama, terdapat perbezaan antara kajian dalam kaedah masing‐masing, yang merangkumi perbezaan dalam jenis ubat yang digunakan, peringkat bersalin di mana prosedur epidural dilakukan, dan penggunaan serentak bentuk kelegaaan kesakitan sebagai tambahan kepada epidural bersalin. Perbezaan antara kajian yang disertakan ini boleh menyumbang kepada perbezaan yang diperhatikan antara AMB dan BI. Kedua, beberapa keputusan kami adalah berdasarkan data yang diperoleh daripada sebilangan kecil wanita, yang mungkin mengehadkan ketepatan penemuan kami.

Sejauh manakah bukti ini terkini?

Ulasan ini mengemas kini ulasan terdahulu dan menyertakan bukti yang diterbitkan sehingga 31 Disember 2022.