Quick Epidural Top-up With Alkalinized Lidocaine for Emergent Caesarean Delivery (QETAL)
Primary Purpose
Obstetric Labor Complications
Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Lidocaine epinephrine buffered with sodium bicarbonate
Lidocaine epinephrine
Sponsored by
About this trial
This is an interventional treatment trial for Obstetric Labor Complications focused on measuring epidural analgesia, caesarean section, sodium bicarbonate, local anesthetics, obstetric labor, alkalinization, extremely urgent
Eligibility 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. extremely urgent caesarean section)
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 : adrenalized lidocaine ; sodium bicarbonate.
- Persons placed under judicial protection
Sites / Locations
- CH de la Côte BasqueRecruiting
- CHU de BordeauxRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental group
Comparator group
Arm Description
In this arm patients will receive for epidural extension a Lidocaine epinephrine buffered with sodium bicarbonate.
In this arm patients will receive for epidural extension only Lidocaine epinephrine.
Outcomes
Primary Outcome Measures
Resort to general anaesthesia
Resort to general anaesthesia for insufficient analgesia after epidural extension for extremely urgent caesarean section.
Secondary Outcome Measures
Delay between fetal extraction decision and birth
Minutes between the decision to extract the fetus by the obstetrical team and the clamping of the umbilical cord
Delay between fetal extraction decision and incision
Minutes between the decision to extract the fetus by the obstetrical team and the surgical incision
Maternal complications
Maternal complications after epidural top-up, including nausea-vomiting in the peroperative and postoperative period, desaturation episode, difficult orotracheal intubation, bronchial inhalation syndrome, hypotensive episode before fetal extraction, extended sensory or motor block.
Complementary medicines
Use and characterization of complementary medicines necessary for maternal well-being during caesarean section.
Postpartum hemorrhage
Postpartum hemorrhage (blood loss of more than 500 ml)
Paediatric wellness
Paediatric wellness criteria (umbilical cord pH less than 7.0 ; umbilical cord lactate)
Anesthesia level
Anesthesia level one hour after surgical incision
Maternal satisfaction
Maternal satisfaction regarding analgesia and anesthesia during caesarean section.
Full Information
NCT ID
NCT05313256
First Posted
March 28, 2022
Last Updated
September 26, 2022
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT05313256
Brief Title
Quick Epidural Top-up With Alkalinized Lidocaine for Emergent Caesarean Delivery
Acronym
QETAL
Official Title
Alkalinization of Adrenalized Lidocaine in Extending Epidural Analgesia for Extremely Urgent Cesarean Section During Labor: a Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prospective randomized study comparing the use of lidocaine 2% with epinephrine buffered with sodium bicarbonate and lidocaine 2% with epinephrine as epidural top-up for extremely urgent cesarean section during labour.
Detailed Description
General anesthesia in pregnant women remains burdened by a significant maternal-fetal morbidity and mortality. An increased risk of orotracheal intubation difficulty, gastric inhalation syndrome and neonatal respiratory depression is described.
The rate of epidural analgesia during labor is about 85% in France. In addition to the comfort provided, epidural analgesia allows emergency Caesarean sections to be performed by converting epidural analgesia to epidural anesthesia, a technique known as "epidural extension" or "epidural top-up". The effectiveness and the time necessary to obtain this surgical anesthesia depends on the protocols used and determines the possibility of performing fetal extractions, even the most urgent ones, without resorting to general anesthesia.
We define an extremely urgent cesarean delivery as a delivery required in the event of an immediate threat to maternal or fetal vital prognosis, with a target of less than 15 minutes between the extraction decision time and birth.
In France, the latest recommendations date from 2007 and recommend the practice of epidural extension with 15 to 20 ml of 2% adrenaline lidocaine. With this technique, surgical anesthesia is typically obtained within 10 to 15 minutes. This time remains too long in certain obstetrical emergency situations, notably extremely urgent cesarean sections, which require frequent recourse to general anesthesia to compensate for this length of nerve block installation.
The alkalinization of local anesthetics with sodium bicarbonate has been experimentally studied since the 1970s and makes it possible to accelerate the time of action of local anesthetics. Alkalinization of local anesthetics is practiced in 35% of epidural extensions in Denmark and 12% of epidural extensions in the United Kingdom.
Since 2016, this technique has been used in the anesthesia departments of maternity units of Bayonne and Bordeaux hospitals. In the former, a retrospective study of 51 cases from January 2019 to July 2019 showed a decrease of more than 80% in the rate of recourse to general anesthesia in extremely urgent caesarean sections (4/4 vs 0/7) and a 50% decrease in the time required to obtain adequate epidural anesthesia (5 min vs 10 min).
The main objective of the current prospective study is to prospectively confirm the decrease in the use of general anesthesia in extremely urgent cesarean sections.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Labor Complications
Keywords
epidural analgesia, caesarean section, sodium bicarbonate, local anesthetics, obstetric labor, alkalinization, extremely urgent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
In this arm patients will receive for epidural extension a Lidocaine epinephrine buffered with sodium bicarbonate.
Arm Title
Comparator group
Arm Type
Active Comparator
Arm Description
In this arm patients will receive for epidural extension only Lidocaine epinephrine.
Intervention Type
Drug
Intervention Name(s)
Lidocaine epinephrine buffered with sodium bicarbonate
Intervention Description
When an extremely urgent fetal extraction by caesarean section is decided, the patient will be randomized. An epidural top-up will then be performed with Lidocaine epinephrine buffered with sodium bicarbonate.
Intervention Type
Drug
Intervention Name(s)
Lidocaine epinephrine
Intervention Description
When an extremely urgent fetal extraction by caesarean section is decided, the patient will be randomized. An epidural top-up will then be performed with Lidocaine epinephrine.
Primary Outcome Measure Information:
Title
Resort to general anaesthesia
Description
Resort to general anaesthesia for insufficient analgesia after epidural extension for extremely urgent caesarean section.
Time Frame
15 minutes after inclusion
Secondary Outcome Measure Information:
Title
Delay between fetal extraction decision and birth
Description
Minutes between the decision to extract the fetus by the obstetrical team and the clamping of the umbilical cord
Time Frame
Between inclusion and birth
Title
Delay between fetal extraction decision and incision
Description
Minutes between the decision to extract the fetus by the obstetrical team and the surgical incision
Time Frame
Between inclusion and cesarean section
Title
Maternal complications
Description
Maternal complications after epidural top-up, including nausea-vomiting in the peroperative and postoperative period, desaturation episode, difficult orotracheal intubation, bronchial inhalation syndrome, hypotensive episode before fetal extraction, extended sensory or motor block.
Time Frame
up to 24 hours after inclusion
Title
Complementary medicines
Description
Use and characterization of complementary medicines necessary for maternal well-being during caesarean section.
Time Frame
Between inclusion and cesarean section
Title
Postpartum hemorrhage
Description
Postpartum hemorrhage (blood loss of more than 500 ml)
Time Frame
up to 24 hours after inclusion
Title
Paediatric wellness
Description
Paediatric wellness criteria (umbilical cord pH less than 7.0 ; umbilical cord lactate)
Time Frame
at birth
Title
Anesthesia level
Description
Anesthesia level one hour after surgical incision
Time Frame
one hour after surgical incision
Title
Maternal satisfaction
Description
Maternal satisfaction regarding analgesia and anesthesia during caesarean section.
Time Frame
up to 4 hours after inclusion
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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. extremely urgent caesarean section)
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 : adrenalized lidocaine ; sodium bicarbonate.
Persons placed under judicial protection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas DENIER D'APRIGNY
Phone
0556795679
Ext
+33
Email
thomas.denier-daprigny@chu-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas BOURGOIN
Phone
0556795679
Ext
+33
Email
nicolas.bourgoin@chu-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas LECHAT, Dr
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antoine BENARD, Dr
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Karine NOUETTE-GAULAIN, Pr
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Study Director
Facility Information:
Facility Name
CH de la Côte Basque
City
Bayonne
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérémy HENRIOT, Dr
Email
jhenriot@ch-cotebasque.fr
First Name & Middle Initial & Last Name & Degree
Jérémy HENRIOT, Dr
Facility Name
CHU de Bordeaux
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas DENIER D'APRIGNY
Email
thomas.denier-daprigny@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Nicolas BOURGOIN
Email
nicolas.bourgoin@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Thomas LECHAT, Dr
12. IPD Sharing Statement
Plan to Share IPD
No
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Quick Epidural Top-up With Alkalinized Lidocaine for Emergent Caesarean Delivery
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