Pregnant women who enter in the delivery room and request epidural analgesia for labour
Conditions
Brief summary
Presence of incomplete sensory block, defined as a Visual Analogue Scale (VAS) score greater than 3 (VAS >3) at 45 minutes after the initiation of epidural analgesia. This will be recorded as a dichotomous variable (Yes/No).
Detailed description
Pain assessment through comparison of mean VAS scores: before performing the technique, at 30 minutes, 60 minutes, during the expulsive phase, and prior to manual epidural reinforcement. (Score 0–10: 0–4 cm mild pain; 5–7 cm moderate pain; 8–10 cm severe pain)., Epidural analgesia failure requiring the performance of a new technique (new technique: Yes/No). Incidence of failure in the conversion from epidural analgesia to epidural anesthesia for intrapartum cesarean section, requiring a new technique, either neuraxial or general anesthesia (failure: Yes/No; new technique: Yes/No; type: sedation, spinal, epidural, combined, general anesthesia)., APGAR at 1 minute and 5 minutes (whole numbers from 1-10) pH in cord blood (number) Lactic acid in cord blood (mmol/L) Admission to NICU (Y/N)., Assessment of motor block using the Bromage scale at 30 minutes, 60 minutes and expulsion, and Bromage prior to manual epidural reinforcement. Frequency of postural changes and ambulation time in minutes. Type of delivery. Indication of caesarean section if necessary and degree of urgency according to Lucas classification., Degree of satisfaction using the BSS-RI scale (Birth Satisfaction Scale-Revised Indicator, score 0-12, attached document). Prolonged epidural block >24h (hours). Urinary retention. Other complications., Number of epidural boluses administered via PCEA (Patient Controlled Epidural Analgesia) and manually requested (in whole numbers: 1, 2, 3…). Failure of PCEA reinforcement (Yes/No). Episodes of breakthrough pain, defined as VAS >3, prior to achieving adequate epidural analgesia, requiring manual reinforcement (in whole numbers: 1, 2, 3…). Administration of paracetamol (Yes/No).
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence of incomplete sensory block, defined as a Visual Analogue Scale (VAS) score greater than 3 (VAS >3) at 45 minutes after the initiation of epidural analgesia. This will be recorded as a dichotomous variable (Yes/No). | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain assessment through comparison of mean VAS scores: before performing the technique, at 30 minutes, 60 minutes, during the expulsive phase, and prior to manual epidural reinforcement. (Score 0–10: 0–4 cm mild pain; 5–7 cm moderate pain; 8–10 cm severe pain)., Epidural analgesia failure requiring the performance of a new technique (new technique: Yes/No). Incidence of failure in the conversion from epidural analgesia to epidural anesthesia for intrapartum cesarean section, requiring a new technique, either neuraxial or general anesthesia (failure: Yes/No; new technique: Yes/No; type: sedation, spinal, epidural, combined, general anesthesia)., APGAR at 1 minute and 5 minutes (whole numbers from 1-10) pH in cord blood (number) Lactic acid in cord blood (mmol/L) Admission to NICU (Y/N)., Assessment of motor block using the Bromage scale at 30 minutes, 60 minutes and expulsion, and Bromage prior to manual epidural reinforcement. Frequency of postural changes and ambulation time in minute | — |
Countries
Spain