LEVOBUPIVACAINE for Labour (epidural analgesia)

Inclusion criteria

• {"criterion_text":"- Primiparous pregnant women in labor either spontaneously or by induction of labor, presenting in both cases cervical dilatation > 3 cm upon admission to the dilatation room (1st active phase of labor).\n- Able to provide written informed consent, or have a legal representative who can provide it.\n- Able to understand the nature of the study and related procedures, as well as to comply with them.\n- Freely accepts participation in the study and gives written informed consent obtained in accordance with international guidelines and local legislation."}

Exclusion criteria

• {"criterion_text":"- Second parturients or history of more vaginal deliveries.\n- Any other condition that, in the opinion of the investigator, may interfere with the evaluation of the results of the study.\n- IMC >40 kg/m2.\n- Contraindications for the epidural technique (neurological pathology, hemostasis alterations, refusal of the patient to receive epidural analgesia).\n- Accidental dural puncture.\n- The patient presents any condition or situation that prevents or interferes with compliance with the study protocol.\n- The patient has a significant underlying disease that, in the opinion of the investigator, could prevent or alter her participation in the study.\n- Any other condition that, in the opinion of the researcher, may interfere with the evaluation of the results of the study.\n- Pregnant women who do not achieve a sufficient level of analgesia and experience epidural analgesia failure 50 minutes after the initiation of the technique, due to the absence of any sensory and/or motor block or its lateralization, secondary to incorrect catheter placement outside the epidural space or laterally within it, requiring a new neuraxial technique."}

Primary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Measured using Visual Analogue Scale (VAS) at 45 minutes after initiation of epidural analgesia; endpoint recorded dichotomously as Yes/No for VAS >3."}

Secondary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Mean VAS (0–10) measured at specified timepoints (baseline, 30 min, 60 min, expulsive phase, prior to manual reinforcement) and compared between groups."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Recorded incidence of epidural analgesia failure requiring a new anaesthetic technique; capture whether failure occurred and type of new technique (sedation, spinal, epidural, combined, general anesthesia)."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Neonatal outcomes: APGAR scores at 1 and 5 minutes, cord blood pH, cord blood lactic acid (mmol/L), and NICU admission (Yes/No)."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Motor block assessed via Bromage scale at specified times; record postural change frequency, ambulation time (minutes), delivery type, and caesarean indication/urgency (Lucas classification)."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Maternal satisfaction measured with BSS-RI (score 0–12); record prolonged epidural block >24 hours, urinary retention, and other complications."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Record number of PCEA and manual boluses, PCEA reinforcement failure (Yes/No), episodes of breakthrough pain (VAS >3) requiring manual reinforcement (counts), and paracetamol administration (Yes/No)."}

Spain

Earliest CTIS Part Ii Submission Date

02-07-2025

Latest Decision Or Authorization Date

29-08-2025

Processing Time Days

58

Number Of Sites

1

Number Of Participants

534

Primary sponsor

Full Name

Hospital Universitario La Paz

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain