Alkalinization of adrenalized lidocaine in extending epidural analgesia for extremely urgent cesarean section during labor: a randomized controlled trial.

Alkalinization of adrenalized lidocaine in extending epidural analgesia for extremely urgent cesarean section during labor: a randomized controlled trial. - QETAL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-006632-67-FR

Enrollment

Registered

2022-01-31

Start date

2022-03-14

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

epidural analgesia for extremely urgent cesarean MedDRA version: 20.0 Level: SOC Classification code 10036585 Term: Pregnancy, puerperium and perinatal conditions System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions

Interventions

Trade Name: XYLOCAINE 20 mg/ml ADRENALINE 0,005 mg/ml sol inj Pharmaceutical Form: Solution for injection INN or Proposed INN: Lidocaïne chlorhydrate anhydre CAS Number: 73-78-9 Other descriptive name

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adult patients, - Affiliated to social security - Informed consent signed by the participant and the investigating physician at the latest after the therapeutic intervention - Initial indication for vaginal delivery - Benefiting from emergency caesarean section during labour for fetal extraction with a maximum 15-minute decision-to-delivery delay (i.e. "code red" Caesarean section) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 66 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Opposition to participation in research before delivery - Refusal or impossibility of informed consent - Lack of understanding or significant language barrier - Initial indication for general anaesthesia defined by the following situations: non-functional epidural analgesia, altered consciousness, eclampsia, suspicion of amniotic embolism, confirmed or suspected severe haemorrhage occurring before birth - Contraindication to the use of the products defined in the protocol : lidocaïne - Persons placed under judicial protection

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this study is to compare the proportion of resorting to maternal general anesthesia with tracheal intubation before cord clamping for lack of analgesia after epidural extension performed for extreme emergency cesarean section ("code red" cesarean section) during obstetrical labor, between patients receiving lidocaine alone and patients receiving lidocaine and bicarbonates;Secondary Objective: Secondary objectives will be to compare between patients receiving lidocaine alone and patients receiving a lidocaine-bicarbonate combination: -Delay between fetal extraction decision and birth -Delay between fetal extraction decision and incision -Maternal complications after epidural top-up, including nausea-vomiting in the peroperative and postoperative period, desaturation episode (SpO2 2 direct laryngoscopy), bronchial inhalation syndrome, hypotensive episode before fetal extraction (MAP < 65 mmHg), extended sensory or motor block (= C8 level). -Use and characterization of complementary medicines necessary for maternal well-being during caesarean section -Postpartum hemorrhage (blood loss of more than 500 ml) -Paediatric welfare criteria (umbilical cord pH less than 7.0 ; umbilical cord lactate) -Anesthesia level one hour after surgical incision -Maternal satisfaction regarding analgesia and anesthesia during caesarean section.;Primary end point(s): Resort to general anaesthesia for insufficient analgesia after epidural extension for code-red caesarean section;Timepoint(s) of evaluation of this end point: up to 15 minutes after epidural extension	—

Measure

Time frame

Main Objective: The main objective of this study is to compare the proportion of resorting to maternal general anesthesia with tracheal intubation before cord clamping for lack of analgesia after epidural extension performed for extreme emergency cesarean section ("code red" cesarean section) during obstetrical labor, between patients receiving lidocaine alone and patients receiving lidocaine and bicarbonates;Secondary Objective: Secondary objectives will be to compare between patients receiving lidocaine alone and patients receiving a lidocaine-bicarbonate combination: -Delay between fetal extraction decision and birth -Delay between fetal extraction decision and incision -Maternal complications after epidural top-up, including nausea-vomiting in the peroperative and postoperative period, desaturation episode (SpO2 2 direct laryngoscopy), bronchial inhalation syndrome, hypotensive episode before fetal extraction (MAP < 65 mmHg), extended sensory or motor block (= C8 level). -Use and characterization of complementary medicines necessary for maternal well-being during caesarean section -Postpartum hemorrhage (blood loss of more than 500 ml) -Paediatric welfare criteria (umbilical cord pH less than 7.0 ; umbilical cord lactate) -Anesthesia level one hour after surgical incision -Maternal satisfaction regarding analgesia and anesthesia during caesarean section.;Primary end point(s): Resort to general anaesthesia for insufficient analgesia after epidural extension for code-red caesarean section;Timepoint(s) of evaluation of this end point: up to 15 minutes after epidural extension

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Secondary

Measure	Time frame
Secondary end point(s): - Delay between fetal extraction decision and birth - Delay between fetal extraction decision and incision - Maternal complications after epidural top-up, including nausea-vomiting in the peroperative and postoperative period, desaturation episode (SpO2 2 direct laryngoscopy), bronchial inhalation syndrome, hypotensive episode before fetal extraction (MAP < 65 mmHg), extended sensory or motor block (= C8 level). - Use and characterization of complementary medicines necessary for maternal well-being during caesarean section - Postpartum hemorrhage (blood loss of more than 500 ml) - Paediatric welfare criteria (umbilical cord pH less than 7.0 ; umbilical cord lactate) - Anesthesia level one hour after surgical incision - Maternal satisfaction regarding analgesia and anesthesia during caesarean section. ;Timepoint(s) of evaluation of this end point: Between epidural extension and 2 hours after delivery	—

Measure

Time frame

Secondary end point(s): - Delay between fetal extraction decision and birth - Delay between fetal extraction decision and incision - Maternal complications after epidural top-up, including nausea-vomiting in the peroperative and postoperative period, desaturation episode (SpO2 2 direct laryngoscopy), bronchial inhalation syndrome, hypotensive episode before fetal extraction (MAP < 65 mmHg), extended sensory or motor block (= C8 level). - Use and characterization of complementary medicines necessary for maternal well-being during caesarean section - Postpartum hemorrhage (blood loss of more than 500 ml) - Paediatric welfare criteria (umbilical cord pH less than 7.0 ; umbilical cord lactate) - Anesthesia level one hour after surgical incision - Maternal satisfaction regarding analgesia and anesthesia during caesarean section. ;Timepoint(s) of evaluation of this end point: Between epidural extension and 2 hours after delivery

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Countries

France

Contacts

Public ContactREC

CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX, ETABLISSEMENT PUBLIC

patrick.cassai@chu-bordeaux.fr+330557820334

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026