{"title":"用于分娩镇痛起始的程序化间歇硬膜外注射与人工硬膜外注射：随机非劣效性试验。","authors":"Yan Lu, Yueqi Zhang, Yuhan Zheng, Yujie Song, Yu Zang, Zhiqiang Liu, Zhendong Xu","doi":"10.2147/DDDT.S488920","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>Typically, labor analgesia is initiated with a manual loading dose. The programmed intermittent epidural bolus (PIEB) effectively maintains labor analgesia. However, no PIEB method has been studied for the initial loading dose. This study aimed to compare the effectiveness of loading doses administered via a PIEB versus a manual bolus.</p><p><strong>Patients and methods: </strong>In total, 164 full-term singleton parturients were randomly assigned to receive a 12 mL loading dose (0.1% ropivacaine and 0.3 μg·mL<sup>-1</sup> sufentanil) via manual or pump-driven injection. A standardized maintenance protocol was employed. The primary outcome was the percentage of parturients with adequate analgesia 20 min after the initial epidural injection. Adequate analgesia was defined as a numeric rating score (NRS) of ≤3 during two consecutive uterine contractions, without an additional analgesia request. Kaplan-Meier survival curves were constructed for the time interval needed to achieve adequate analgesia. A non-inferiority analysis was conducted by comparing the 90% confidence interval of the pain score difference with the non-inferiority margin.</p><p><strong>Results: </strong>The percentage of parturients achieving adequate analgesia was comparable (75.61% manual injection vs 76.83% pump injection, <i>P</i>=0.05 for non-inferiority). The median NRS was similar, except at 2 min (7 [5-8] manual injection vs 8 [6-9] pump injection, <i>P</i>=0.04). Median time to adequate analgesia, median ropivacaine consumption, median duration of epidural analgesia, incidence of requests for patient-controlled epidural analgesia (PCEA), median number of PCEA boluses, percentage of bilateral S<sub>2</sub> blocks at 20 min, incidence of breakthrough pain, percentage of highest block level ≥T6 at 20 min, adverse effects, and obstetric and neonatal outcomes were similar between the groups.</p><p><strong>Conclusion: </strong>Within 20 min of administering a loading dose through a PIEB pump, non-inferior analgesia comparable to that achieved with manual injection was observed. This hands-free approach could help mitigate the impact of individual operational differences on analgesic efficacy.</p><p><strong>Registration: </strong>This trial was registered at chictr.org.cn (ChiCTR2300074063).</p>","PeriodicalId":11290,"journal":{"name":"Drug Design, Development and Therapy","volume":"18 ","pages":"5063-5072"},"PeriodicalIF":4.7000,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11552411/pdf/","citationCount":"0","resultStr":"{\"title\":\"Programmed Intermittent Epidural Bolus vs Manual Epidural Bolus for Labor Analgesia Initiation: A Randomized Non-Inferiority Trial.\",\"authors\":\"Yan Lu, Yueqi Zhang, Yuhan Zheng, Yujie Song, Yu Zang, Zhiqiang Liu, Zhendong Xu\",\"doi\":\"10.2147/DDDT.S488920\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>Typically, labor analgesia is initiated with a manual loading dose. The programmed intermittent epidural bolus (PIEB) effectively maintains labor analgesia. However, no PIEB method has been studied for the initial loading dose. This study aimed to compare the effectiveness of loading doses administered via a PIEB versus a manual bolus.</p><p><strong>Patients and methods: </strong>In total, 164 full-term singleton parturients were randomly assigned to receive a 12 mL loading dose (0.1% ropivacaine and 0.3 μg·mL<sup>-1</sup> sufentanil) via manual or pump-driven injection. A standardized maintenance protocol was employed. The primary outcome was the percentage of parturients with adequate analgesia 20 min after the initial epidural injection. Adequate analgesia was defined as a numeric rating score (NRS) of ≤3 during two consecutive uterine contractions, without an additional analgesia request. Kaplan-Meier survival curves were constructed for the time interval needed to achieve adequate analgesia. A non-inferiority analysis was conducted by comparing the 90% confidence interval of the pain score difference with the non-inferiority margin.</p><p><strong>Results: </strong>The percentage of parturients achieving adequate analgesia was comparable (75.61% manual injection vs 76.83% pump injection, <i>P</i>=0.05 for non-inferiority). The median NRS was similar, except at 2 min (7 [5-8] manual injection vs 8 [6-9] pump injection, <i>P</i>=0.04). Median time to adequate analgesia, median ropivacaine consumption, median duration of epidural analgesia, incidence of requests for patient-controlled epidural analgesia (PCEA), median number of PCEA boluses, percentage of bilateral S<sub>2</sub> blocks at 20 min, incidence of breakthrough pain, percentage of highest block level ≥T6 at 20 min, adverse effects, and obstetric and neonatal outcomes were similar between the groups.</p><p><strong>Conclusion: </strong>Within 20 min of administering a loading dose through a PIEB pump, non-inferior analgesia comparable to that achieved with manual injection was observed. This hands-free approach could help mitigate the impact of individual operational differences on analgesic efficacy.</p><p><strong>Registration: </strong>This trial was registered at chictr.org.cn (ChiCTR2300074063).</p>\",\"PeriodicalId\":11290,\"journal\":{\"name\":\"Drug Design, Development and Therapy\",\"volume\":\"18 \",\"pages\":\"5063-5072\"},\"PeriodicalIF\":4.7000,\"publicationDate\":\"2024-11-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11552411/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Drug Design, Development and Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.2147/DDDT.S488920\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"CHEMISTRY, MEDICINAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drug Design, Development and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2147/DDDT.S488920","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"CHEMISTRY, MEDICINAL","Score":null,"Total":0}
Programmed Intermittent Epidural Bolus vs Manual Epidural Bolus for Labor Analgesia Initiation: A Randomized Non-Inferiority Trial.
Purpose: Typically, labor analgesia is initiated with a manual loading dose. The programmed intermittent epidural bolus (PIEB) effectively maintains labor analgesia. However, no PIEB method has been studied for the initial loading dose. This study aimed to compare the effectiveness of loading doses administered via a PIEB versus a manual bolus.
Patients and methods: In total, 164 full-term singleton parturients were randomly assigned to receive a 12 mL loading dose (0.1% ropivacaine and 0.3 μg·mL-1 sufentanil) via manual or pump-driven injection. A standardized maintenance protocol was employed. The primary outcome was the percentage of parturients with adequate analgesia 20 min after the initial epidural injection. Adequate analgesia was defined as a numeric rating score (NRS) of ≤3 during two consecutive uterine contractions, without an additional analgesia request. Kaplan-Meier survival curves were constructed for the time interval needed to achieve adequate analgesia. A non-inferiority analysis was conducted by comparing the 90% confidence interval of the pain score difference with the non-inferiority margin.
Results: The percentage of parturients achieving adequate analgesia was comparable (75.61% manual injection vs 76.83% pump injection, P=0.05 for non-inferiority). The median NRS was similar, except at 2 min (7 [5-8] manual injection vs 8 [6-9] pump injection, P=0.04). Median time to adequate analgesia, median ropivacaine consumption, median duration of epidural analgesia, incidence of requests for patient-controlled epidural analgesia (PCEA), median number of PCEA boluses, percentage of bilateral S2 blocks at 20 min, incidence of breakthrough pain, percentage of highest block level ≥T6 at 20 min, adverse effects, and obstetric and neonatal outcomes were similar between the groups.
Conclusion: Within 20 min of administering a loading dose through a PIEB pump, non-inferior analgesia comparable to that achieved with manual injection was observed. This hands-free approach could help mitigate the impact of individual operational differences on analgesic efficacy.
Registration: This trial was registered at chictr.org.cn (ChiCTR2300074063).
期刊介绍：
Drug Design, Development and Therapy is an international, peer-reviewed, open access journal that spans the spectrum of drug design, discovery and development through to clinical applications.
The journal is characterized by the rapid reporting of high-quality original research, reviews, expert opinions, commentary and clinical studies in all therapeutic areas.
Specific topics covered by the journal include:
Drug target identification and validation
Phenotypic screening and target deconvolution
Biochemical analyses of drug targets and their pathways
New methods or relevant applications in molecular/drug design and computer-aided drug discovery*
Design, synthesis, and biological evaluation of novel biologically active compounds (including diagnostics or chemical probes)
Structural or molecular biological studies elucidating molecular recognition processes
Fragment-based drug discovery
Pharmaceutical/red biotechnology
Isolation, structural characterization, (bio)synthesis, bioengineering and pharmacological evaluation of natural products**
Distribution, pharmacokinetics and metabolic transformations of drugs or biologically active compounds in drug development
Drug delivery and formulation (design and characterization of dosage forms, release mechanisms and in vivo testing)
Preclinical development studies
Translational animal models
Mechanisms of action and signalling pathways
Toxicology
Gene therapy, cell therapy and immunotherapy
Personalized medicine and pharmacogenomics
Clinical drug evaluation
Patient safety and sustained use of medicines.
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