Height Adjusted Versus Standardized Dose of Bupivacaine for Spinal Anesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-23

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Regional Anesthesia Morbidity Cesarean Section Complications Local Anesthetic Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled double blind trial

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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control group

intrathecal administration of a solution containing

* bupivacaine 10 mg
* morphine 100 micrograms
* sufentanil 3 micrograms

Group Type ACTIVE_COMPARATOR

standardized dose

Intervention Type OTHER

intrathecal anesthesia with 10 mg of bupivacaine

individualized group

intrathecal administration of a solution containing

* bupivacaine 0.05 mg per cm of patient's height
* morphine 100 micrograms
* sufentanil 3 micrograms

Group Type EXPERIMENTAL

adjusted dose

Intervention Type OTHER

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

Interventions

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standardized dose

intrathecal anesthesia with 10 mg of bupivacaine

Intervention Type OTHER

adjusted dose

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

Intervention Type OTHER

Other Intervention Names

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standardized dose of bupivacaine adjusted dose of bupivacaine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No