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Recruiting NCT05233462

Height Adjusted Versus Standardized Dose of Bupivacaine for Spinal Anesthesia

No phase Interventional Regional Anesthesia Morbidity Cesarean Section Complications Local Anesthetic Complication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: standardized dose, adjusted dose.
Who it may be relevant to
Registry conditions: Regional Anesthesia Morbidity, Cesarean Section Complications, Local Anesthetic Complication. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Height Adjusted Versus Standardized Dose of Bupivacaine in Spinal Anesthesia for Caesarean Delivery - A Randomized Double-blind Interventional Study

Overview

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.

Detailed description

The present controlled randomized double blind trial was designed to compare 2 intrathecal dose of bupivacaine for cesarean section

* a "standard" dose of 10 mg of intrathecal bupivacaine associated with morphine 100 micrograms and sufentanil 3 micrograms * a height-calculated dose of bupivacaine (0.05 mg per cm of height) on associated with morphine 100 micrograms and sufentanil 3 micrograms

The main outcome is the rate of hypotension defined as a 20% or more decrease in systolic arterial pressure.

Secondary outcomes focused on intrathecal anesthesia efficacy, success or failure and on interventions required to manage arterial hypotension

Interventions

  • Other standardized dose
    intrathecal anesthesia with 10 mg of bupivacaine
  • Other adjusted dose
    intrathecal anesthesia with 0.05 mg of bupivacaine par cm of patient's height

Primary outcome measures

  • rate of arterial hypotension [Time frame: 4 hours since the start of intrathecal bupivacaine administration]
Secondary outcome measures (5)
  • vasopressor total dose [Time frame: 4 hours since the start of intrathecal bupivacaine administration]
  • metameric level of intrathecal anesthesia [Time frame: 4 hours since the start of intrathecal bupivacaine administration]
  • lower limb motor block at the end of the caesarean section [Time frame: 5 min after the end of caesarean section at newborn umbilical cord clamp]
  • rate of need for general anesthesia [Time frame: 5 min after the end of caesarean section at newborn umbilical cord clamp]
  • patient's comfort self evaluation [Time frame: 4 hours since the start of intrathecal bupivacaine administration]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

France · 1 center
  • Caen University Hospital — Caen

Identifiers

NCT: NCT05233462 · 21-0217

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗