Prediction of Local Anaesthetic Dosing During Labour Epidural Analgesia (DIANA)
perjantai 22. toukokuuta 2026 päivittänyt: ZANFINI BRUNO ANTONIO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Prediction of Local Anaesthetic Dosing During Labour Epidural Analgesia: a Machine-learning Approach. The DIANA (Dosing Intrapartum ANAesthetics) Study.
Epidural analgesia is the gold standard for controlling labour pain. However, labour pain happens during neuraxial analgesia, due to anaesthetic, obstetric, maternal factors.
The investigators hypothesized that relevant variables, able to predict the local anaesthetic (LA) requirement during labour, can be identified at admission and each parturient may therefore be accordingly classified in "low-requirement" and "high-requirement". In this way, a predictive score may be developed, and the analgesic regimen may be matched to the individual patient, thus ensuring a timely and appropriate treatment of patients likely to require higher doses of LA, while minimizing potentially side effects of excessive treatment in the low-dose group.
Tutkimuksen yleiskatsaus
Tila
Ei vielä rekrytointia
Ehdot
Interventio / Hoito
Opintotyyppi
Havainnollistava
Ilmoittautuminen (Arvioitu)
12500
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Bruno A Zanfini, MD
- Puhelinnumero: 06 3015 3105
- Sähköposti: brunoantonio.zanfini@policlinicogemelli.it
Opiskelupaikat
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RM
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Rome, RM, Italia, 00168
- Fondazione Policlinico Universitario A. Gemelli IRCCS
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Näytteenottomenetelmä
Ei-todennäköisyysnäyte
Tutkimusväestö
All parturients who delivered via vaginal route or intrapartum caesarean section and received neuraxial analgesia (epidural analgesia (EA) or combined spinal-epidural [CSE] analgesia or dural puncture epidural (DPE)) in Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, between January 1st, 2020 and March 01th, 2026 (including follow-up data), meeting the inclusion criteria.
Kuvaus
Inclusion Criteria:
- Parturients receiving neuraxial analgesia for labour, as clinical practice
Exclusion Criteria:
- Planned caesarean delivery
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
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All parturients between January 2020 and March 2026
All parturients who delivered via vaginal route or intrapartum caesarean section and received neuraxial analgesia (epidural analgesia (EA) or combined spinal-epidural [CSE] analgesia or dural puncture epidural (DPE)) in Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, between January 1st, 2020 and March 01th, 2026 (including follow-up data), meeting the inclusion criteria.
Labour analgesia was maintained through manual top-up boluses or PIEB (Programmed Intermittent Epidural Bolus).
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A machine-learning prediction model will be developed to anticipate the parturient's requirement of LA at admission in the Labour Suite, according to demographic, obstetric and anaesthetic features ongoing before administration of the first epidural bolus.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Machine-learning algorithm able to predict the LA consumption
Aikaikkuna: From the epidural catheter placement to delivery.
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To develop a machine-learning algorithm able to predict the mean hourly cumulative LA consumption administered via the epidural catheter from the catheter placement up to delivery, expressed as time-weighted LA consumption per hour (mg/h) in patients receiving top-up analgesia or the need for adjunctive rescue LA boluses in patients receiving PIEB (Programmed Intermittent Epidural Bolus) analgesia.
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From the epidural catheter placement to delivery.
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Clinical score
Aikaikkuna: At admission in the Labour Suite and before the epidural catheter is placed
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To develop a clinical score, based on the machine learning algorithm, with the aim of predicting the patient's LA requirement at admission, thus categorizing parturients as "low requirement" or "high requirement".
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At admission in the Labour Suite and before the epidural catheter is placed
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Time-dependent AUC of LA manual boluses
Aikaikkuna: From epidural catheter placement to delivery.
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To compare (between low- and high-requirement parturients) the time-dependent AUC of LA boluses (in case of analgesia maintenance through top-up) and the time-dependent AUC of adjunctive rescue LA boluses (in case of analgesia maintenance through PIEB)
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From epidural catheter placement to delivery.
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Total LA consumption
Aikaikkuna: From epidural catheter placement to delivery.
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To compare between low- and high-requirement parturients the total LA consumption (mg), mean (+-SD)
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From epidural catheter placement to delivery.
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Ratio of time to first bolus demand to duration of labor
Aikaikkuna: From epidural catheter placement to delivery.
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To compare between low- and high-requirement parturients the ratio of time to first bolus demand to duration of labor (%), mean (+-SD), in case of analgesia maintenance through top-up.
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From epidural catheter placement to delivery.
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Total demand of LA boluses
Aikaikkuna: From epidural catheter placement to delivery.
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To compare between low- and high-requirement parturients the total demand of LA boluses, mean (+-SD), in case of analgesia maintenance through top-up.
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From epidural catheter placement to delivery.
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Total adjunctive rescue LA epidural boluses
Aikaikkuna: From epidural catheter placement to delivery.
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To compare between low- and high-requirement parturients the total adjunctive rescue LA epidural boluses, mean (+-SD), in case of analgesia maintenance through PIEB.
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From epidural catheter placement to delivery.
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Length of active phase
Aikaikkuna: From start of the active phase to full cervical dilation, up to 24 hours.
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To compare between low- and high-requirement parturients the length of active phase in minutes, mean (+-SD).
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From start of the active phase to full cervical dilation, up to 24 hours.
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Length of second stage
Aikaikkuna: From full cervical dilation to delivery.
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To compare between low- and high-requirement parturients the length of second stage in minutes, mean (+-SD).
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From full cervical dilation to delivery.
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Rate of postpartum haemorrhage
Aikaikkuna: In the first hour after delivery.
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To compare between low- and high-requirement parturients the rate of postpartum haemorrhage, expressed as percentage.
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In the first hour after delivery.
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Rate of perineal laceration
Aikaikkuna: In the first hour after delivery.
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To compare between low- and high-requirement parturients the rate of perineal laceration, expressed as percentage.
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In the first hour after delivery.
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Rate of episiotomy
Aikaikkuna: At delivery.
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To compare between low- and high-requirement parturients the rate of episiotomy, expressed as percentage.
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At delivery.
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Rate of shoulder dystocia
Aikaikkuna: At delivery.
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To compare between low- and high-requirement parturients the rate of shoulder dystocia, expressed as percentage.
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At delivery.
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Rate of intrapartum caesarean section
Aikaikkuna: From admission to the Labour suite to delivery, up to 24 hours.
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To compare between low- and high-requirement parturients the rate of intrapartum caesarean section, expressed as percentage.
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From admission to the Labour suite to delivery, up to 24 hours.
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Rate of catheter re-siting during labour
Aikaikkuna: From the placement of the first epidural catheter to delivery, up to 24 hours.
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To compare between low- and high-requirement parturients the rate of catheter re-siting during labour, expressed as percentage.
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From the placement of the first epidural catheter to delivery, up to 24 hours.
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Rate of neonatal admission in NICU
Aikaikkuna: After delivery, up to 1 hour.
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To compare between low- and high-requirement parturients the rate of neonatal admission in Neonatal Intensive Care Unit (NICU).
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After delivery, up to 1 hour.
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Mean Apgar Score at 1 minute
Aikaikkuna: 1 minute after delivery.
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To compare between low- and high-requirement parturients the neonatal Apgar score at 1 minute, expressed as mean +- DS.
The Apgar score is a 10-point evaluation scoring system used to assess a newborn's health immediately after birth, based on 5 criteria: Appearance, Pulse, Grimace, Activity, and Respiration.
Each category is assigned a score of 0, 1 or 2.
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1 minute after delivery.
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Mean Apgar Score at 5 minutes
Aikaikkuna: 5 minutes after delivery.
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To compare between low- and high-requirement parturients the neonatal Apgar score at 5 minutes, expressed as mean +- DS.
The Apgar score is a 10-point evaluation scoring system used to assess a newborn's health immediately after birth, based on 5 criteria: Appearance, Pulse, Grimace, Activity, and Respiration.
Each category is assigned a score of 0, 1 or 2.
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5 minutes after delivery.
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Mean Umbilical Cord Arterial pH
Aikaikkuna: At delivery.
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To compare between low- and high-requirement parturients the umbilical cord arterial pH, expressed as mean +- DS.
Reference ranges of cord arterial pH is 7.2 - 7.4.
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At delivery.
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Mean Umbilical Cord Venous pH
Aikaikkuna: At delivery.
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To compare between low- and high-requirement parturients the umbilical cord venous pH, expressed as mean +- DS.
Reference ranges of cord venous pH is 7.25 - 7.45.
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At delivery.
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Mean Umbilical Cord Arterial base excess
Aikaikkuna: At delivery.
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To compare between low- and high-requirement parturients the umbilical cord arterial base excess, expressed as mean +- DS.
Reference ranges of cord arterial base excess is -9 to +2.
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At delivery.
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Mean Umbilical Cord Venous base excess
Aikaikkuna: At delivery.
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To compare between low- and high-requirement parturients the umbilical cord venous base excess, expressed as mean +- DS.
Reference ranges of cord venous base excess is -10 to +0.
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At delivery.
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The rate of maternal hypertensive disorders.
Aikaikkuna: Throughout pregnancy, up to the first postpartum day.
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To compare between low- and high-requirement parturients the rate of maternal hypertensive disorders.
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Throughout pregnancy, up to the first postpartum day.
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The rate of gestational diabetes.
Aikaikkuna: Throughout pregnancy, up to delivery.
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To compare between low- and high-requirement parturients the rate of gestational diabetes.
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Throughout pregnancy, up to delivery.
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