Introduction Neuraxial labour analgesia represents the gold standard for pain control during childbirth. Programmed Intermittent Epidural Bolus (PIEB) has emerged as a valid alternative to continuous epidural infusion, with potential advantages in terms of analgesic quality and organisational efficiency. In our centre, a standardised PIEB protocol has been implemented and evaluated. Objectives To assess analgesic efficacy, maternal–fetal safety, and anaesthesiological and obstetric outcomes of two PIEB-based neuraxial labour analgesia protocols—a standard epidural protocol and a Combined Spinal–Epidural (CSE) protocol—and to investigate the possible clinical superiority of one protocol over the other. Methods This prospective observational study included nulliparous women receiving neuraxial labour analgesia with a PIEB technique between April and December 2025 at the Camposampiero Unit. Demographic and clinical data, pain intensity (NRS), need for rescue boluses, haemodynamic parameters, duration of labour analgesia, anaesthesia-related complications, mode of delivery and neonatal outcomes were collected and compared between the two protocols. Results Seventy nulliparous women were included: 46 (65.7%) received the epidural protocol and 24 (34.3%) the CSE protocol. Baseline characteristics were comparable for age, whereas pre-pregnancy BMI and cervical dilatation at the time of analgesia request were higher in the CSE group. A significant reduction in pain was observed after the first bolus in both groups; however, initial analgesic efficacy was greater in the CSE group (median ΔNRS 8.0 vs 6.5; p=0.0017). Longitudinal analysis using GEE confirmed a greater reduction in pain at several time points in the CSE group, with high and clinically comparable overall analgesic efficacy in both protocols. Maternal and neonatal outcomes were similar: the median 1-minute Apgar score was 9 in both groups, and maternal satisfaction was high and comparable (median 9/10; p=0.78). No significant differences were observed in haemodynamic parameters. The overall incidence of complications was comparable between groups (45.7% in the epidural group vs 43.5% in the CSE group; p=1.00), as was the caesarean section rate (11.4%). The duration of labour analgesia did not differ between protocols (p=0.397), but was longer in non-spontaneous labour than in spontaneous labour (p=0.010) and was associated with an increased risk of operative or caesarean delivery (OR 1.284 per additional hour; p=0.0042). Labour induction was associated with a longer duration of labour analgesia and a significantly higher incidence of complications (p<0.05). The need for rescue boluses was similar between groups (p=0.757) and was positively correlated with the duration of labour analgesia. Conclusions Both PIEB-based neuraxial labour analgesia protocols proved to be effective and safe, with high maternal satisfaction and no clinically relevant differences in obstetric or neonatal outcomes. The CSE technique provides faster and more intense initial analgesia than standard epidural analgesia, without a clinically meaningful advantage during the maintenance phase. The adoption of a standardised PIEB protocol allows a favourable balance between analgesic efficacy and organisational sustainability; future integration of patient-controlled epidural analgesia (PCEA) may represent a further evolution of this care model.
Introduzione La partoanalgesia neurassiale rappresenta il gold standard per il controllo del dolore durante il travaglio di parto. La somministrazione epidurale a boli programmati (Programmed Intermittent Epidural Bolus, PIEB) si è affermata come valida alternativa all’infusione epidurale continua, con potenziali vantaggi in termini di qualità analgesica ed efficienza organizzativa. Nel nostro centro è stato implementato un protocollo PIEB standardizzato, oggetto della presente valutazione clinica. Obiettivi Valutare efficacia analgesica, sicurezza materno-fetale ed esiti anestesiologici e ostetrici di due protocolli di partoanalgesia neurassiale basati su PIEB, uno peridurale standard e uno con tecnica Combined Spinal–Epidural (CSE), verificando l’eventuale superiorità clinica di un protocollo rispetto all’altro. Metodi Studio osservazionale prospettico su partorienti nullipare sottoposte a partoanalgesia neurassiale con tecnica PIEB tra aprile e dicembre 2025 presso l’U.O. di Camposampiero. Sono stati raccolti dati demografici e clinici, punteggi di dolore (NRS), necessità di boli rescue, parametri emodinamici, durata della partoanalgesia, complicanze anestesiologiche, modalità del parto ed esiti neonatali, confrontando gli outcome tra i due protocolli. Risultati Sono state incluse 70 partorienti nullipare: 46 (65,7%) trattate con protocollo peridurale e 24 (34,3%) con protocollo CSE. Le caratteristiche basali erano sovrapponibili per età, mentre BMI pregravidico e dilatazione cervicale al momento della richiesta di analgesia risultavano maggiori nel gruppo CSE. In entrambi i gruppi si osservava una riduzione significativa del dolore dopo il primo bolo; l’efficacia analgesica iniziale risultava superiore nel gruppo CSE (ΔNRS mediano 8,0 vs 6,5; p=0,0017). L’analisi longitudinale mediante GEE confermava una riduzione del dolore più marcata nel gruppo CSE in diversi timepoint, a fronte di un’elevata efficacia complessiva in entrambi i protocolli. Gli esiti materni e neonatali erano sovrapponibili: score di Apgar a 1 minuto mediano pari a 9 in entrambi i gruppi e soddisfazione materna elevata e simile (mediana 9/10; p=0,78). I parametri emodinamici non mostravano differenze significative. L’incidenza complessiva delle complicanze era comparabile (45,7% peridurale vs 43,5% CSE; p=1,00), così come il tasso di taglio cesareo (11,4%). La durata della partoanalgesia non differiva tra i protocolli (p=0,397), ma risultava maggiore nei travagliamenti non spontanei rispetto a quelli spontanei (p=0,010) ed era associata a un incremento del rischio di parto operativo o cesareo (OR 1,284 per ogni ora aggiuntiva; p=0,0042). L’induzione del travaglio era associata a una maggiore durata della partoanalgesia e a un aumento significativo delle complicanze (p<0,05). La necessità di boli rescue era simile tra i gruppi (p=0,757) e correlata positivamente alla durata della partoanalgesia. Conclusioni Entrambi i protocolli di partoanalgesia neurassiale con PIEB si sono dimostrati efficaci e sicuri, con elevata soddisfazione materna e assenza di differenze clinicamente rilevanti negli esiti ostetrici e neonatali. La tecnica CSE garantisce un’analgesia iniziale più rapida e intensa rispetto alla peridurale standard, senza tuttavia determinare una superiorità clinicamente significativa nella fase di mantenimento. L’adozione di un protocollo PIEB standardizzato consente un buon equilibrio tra efficacia analgesica e sostenibilità organizzativa; l’integrazione futura della PCEA potrebbe rappresentare un’ulteriore evoluzione del modello assistenziale.
Partoanalgesia mediante tecnica PIEB: impatto clinico e organizzativo di nuovi protocolli
BANO, GIOIA
2023/2024
Abstract
Introduction Neuraxial labour analgesia represents the gold standard for pain control during childbirth. Programmed Intermittent Epidural Bolus (PIEB) has emerged as a valid alternative to continuous epidural infusion, with potential advantages in terms of analgesic quality and organisational efficiency. In our centre, a standardised PIEB protocol has been implemented and evaluated. Objectives To assess analgesic efficacy, maternal–fetal safety, and anaesthesiological and obstetric outcomes of two PIEB-based neuraxial labour analgesia protocols—a standard epidural protocol and a Combined Spinal–Epidural (CSE) protocol—and to investigate the possible clinical superiority of one protocol over the other. Methods This prospective observational study included nulliparous women receiving neuraxial labour analgesia with a PIEB technique between April and December 2025 at the Camposampiero Unit. Demographic and clinical data, pain intensity (NRS), need for rescue boluses, haemodynamic parameters, duration of labour analgesia, anaesthesia-related complications, mode of delivery and neonatal outcomes were collected and compared between the two protocols. Results Seventy nulliparous women were included: 46 (65.7%) received the epidural protocol and 24 (34.3%) the CSE protocol. Baseline characteristics were comparable for age, whereas pre-pregnancy BMI and cervical dilatation at the time of analgesia request were higher in the CSE group. A significant reduction in pain was observed after the first bolus in both groups; however, initial analgesic efficacy was greater in the CSE group (median ΔNRS 8.0 vs 6.5; p=0.0017). Longitudinal analysis using GEE confirmed a greater reduction in pain at several time points in the CSE group, with high and clinically comparable overall analgesic efficacy in both protocols. Maternal and neonatal outcomes were similar: the median 1-minute Apgar score was 9 in both groups, and maternal satisfaction was high and comparable (median 9/10; p=0.78). No significant differences were observed in haemodynamic parameters. The overall incidence of complications was comparable between groups (45.7% in the epidural group vs 43.5% in the CSE group; p=1.00), as was the caesarean section rate (11.4%). The duration of labour analgesia did not differ between protocols (p=0.397), but was longer in non-spontaneous labour than in spontaneous labour (p=0.010) and was associated with an increased risk of operative or caesarean delivery (OR 1.284 per additional hour; p=0.0042). Labour induction was associated with a longer duration of labour analgesia and a significantly higher incidence of complications (p<0.05). The need for rescue boluses was similar between groups (p=0.757) and was positively correlated with the duration of labour analgesia. Conclusions Both PIEB-based neuraxial labour analgesia protocols proved to be effective and safe, with high maternal satisfaction and no clinically relevant differences in obstetric or neonatal outcomes. The CSE technique provides faster and more intense initial analgesia than standard epidural analgesia, without a clinically meaningful advantage during the maintenance phase. The adoption of a standardised PIEB protocol allows a favourable balance between analgesic efficacy and organisational sustainability; future integration of patient-controlled epidural analgesia (PCEA) may represent a further evolution of this care model.| File | Dimensione | Formato | |
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https://hdl.handle.net/20.500.12608/103889