NCT05233462

Brief Summary

General anesthesia during pregnancy is associated with several major risks including unanticipated difficult airway, pulmonary aspiration, and specific anesthetic effects on the newborn. Thus, intrathecal anesthesia is the technique of choice for cesarean section. Nevertheless, the main side effect of intrathecal anesthesia is arterial hypotension which depend mainly on the dose of local anesthetic administered intrathecally. To date there is no guidelines nor evidences whic help the anesthetist to precisely estimate the required dose. Most often a "standardized dose" of 8 to 10 mg of bupivacaine is administered. However, some data suggest that a lower dose may be administered resulting in less frequent arterial hypotension. Nevertheless, a well designed randomized study is lacking.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress87%
Feb 2022Dec 2026

First Submitted

Initial submission to the registry

January 31, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

February 23, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

July 25, 2025

Status Verified

July 1, 2025

Enrollment Period

3.9 years

First QC Date

January 31, 2022

Last Update Submit

July 22, 2025

Conditions

Regional Anesthesia MorbidityCesarean Section ComplicationsLocal Anesthetic Complication

Keywords

cesarean sectionintrathecal anesthesiabupivacainemorbidity

Outcome Measures

Primary Outcomes (1)

  • rate of arterial hypotension

    rate of arterial hypotension defined as a 20% or more decrease in systolic arterial pressure as compared with baseline systolic arterial pressure measured at 32 weeks

    4 hours since the start of intrathecal bupivacaine administration

Secondary Outcomes (5)

  • vasopressor total dose

    4 hours since the start of intrathecal bupivacaine administration

  • metameric level of intrathecal anesthesia

    4 hours since the start of intrathecal bupivacaine administration

  • lower limb motor block at the end of the caesarean section

    5 min after the end of caesarean section at newborn umbilical cord clamp

  • rate of need for general anesthesia

    5 min after the end of caesarean section at newborn umbilical cord clamp

  • patient's comfort self evaluation

    4 hours since the start of intrathecal bupivacaine administration

Study Arms (2)

control group

ACTIVE COMPARATOR

intrathecal administration of a solution containing * bupivacaine 10 mg * morphine 100 micrograms * sufentanil 3 micrograms

Other: standardized dose

individualized group

EXPERIMENTAL

intrathecal administration of a solution containing * bupivacaine 0.05 mg per cm of patient's height * morphine 100 micrograms * sufentanil 3 micrograms

Other: adjusted dose

Interventions

standardized doseOTHER

intrathecal anesthesia with 10 mg of bupivacaine

Also known as: standardized dose of bupivacaine
control group
adjusted doseOTHER

intrathecal anesthesia with 0.05 mg of bupivacaine par cm of patient's height

Also known as: adjusted dose of bupivacaine
individualized group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnancy and scheduled cesarean section
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • scheduled cesarean section with intrathecal anesthesia
  • term pregnancy \> 35 weeks
  • signed informed consent

You may not qualify if:

  • unscheduled or emergent cesarean section
  • any contra indication to intrathecal anesthesia
  • any antihypertensive drug prescribed to control arterial pressure during pregnancy
  • pre-eclampsia and eclampsia
  • history of Marfan or Ehlers Danlos disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital

Caen, France

RECRUITING

MeSH Terms

Interventions

EPOCH protocol

Study Officials

  • jean-luc hanouz

    University Hospital of Caen

    STUDY CHAIR

Central Study Contacts

jean-luc hanouz, M.D, Ph.D

CONTACT

02 31 06 47 36hanouz-jl@chu-caen.fr

thérèse simonet, M.D.

CONTACT

02 31 06 47 36simonet-t@chu-caen.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Neither the patient nor the care provider nor the outcome assessor will know the allocation group. Bupivacaine syringe will be prepare, according to the protocol, by a separate anesthetist not involved in the care of the patient. The solution in both groups will have the same volume.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized controlled double blind trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2022

First Posted

February 10, 2022

Study Start

February 23, 2022

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

July 25, 2025

Record last verified: 2025-07

Locations

FR(1)