Clinical trial NCT05233462: Height Adjusted Versus Standardized Dose of Bupivacaine for Spinal Anesthesia
Official title: Height Adjusted Versus Standardized Dose of Bupivacaine in Spinal Anesthesia for Caesarean Delivery - A Randomized Double-blind Interventional Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Regional Anesthesia Morbidity
Cesarean Section Complications
Local Anesthetic Complication
Keywords: cesarean section
intrathecal anesthesia
bupivacaine
morbidity
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled double blind trial
Primary purpose: PREVENTION

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.

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

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

Primary outcomes:
measure: rate of arterial hypotension
timeFrame: 4 hours since the start of intrathecal bupivacaine administration
Secondary outcomes:
measure: vasopressor total dose
timeFrame: 4 hours since the start of intrathecal bupivacaine administration
measure: metameric level of intrathecal anesthesia
timeFrame: 4 hours since the start of intrathecal bupivacaine administration
measure: lower limb motor block at the end of the caesarean section
timeFrame: 5 min after the end of caesarean section at newborn umbilical cord clamp
measure: rate of need for general anesthesia
timeFrame: 5 min after the end of caesarean section at newborn umbilical cord clamp
measure: patient's comfort self evaluation
timeFrame: 4 hours since the start of intrathecal bupivacaine administration
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital of Caen
name: jean-luc hanouz
role: STUDY_CHAIR
References: