Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
ID05233462

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

Led by University Hospital, Caen · Updated on 2025-07-25

250

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the risks associated with general anesthesia during pregnancy, such as airway difficulties and effects on the newborn, which make intrathecal anesthesia the preferred method for cesarean sections. However, a common side effect of intrathecal anesthesia is arterial hypotension, which depends mainly on the dose of local anesthetic given. There is currently no clear guideline to help anesthetists determine the optimal dose, as a standard dose of 8 to 10 mg of bupivacaine is often used, though lower doses might reduce hypotension risks. This trial compares two doses of intrathecal bupivacaine for cesarean delivery: a fixed standard dose of 10 mg combined with morphine and sufentanil, and a height-adjusted dose calculated as 0.05 mg per cm of the patient's height, also combined with morphine and sufentanil. The study is randomized and double-blind, evaluating how these dosing strategies affect the rate of arterial hypotension and related anesthesia outcomes. Participants will undergo cesarean section with one of the two dosing regimens, and researchers will monitor blood pressure for 4 hours after administration to measure hypotension rates. Secondary measures include anesthesia efficacy, motor block, need for general anesthesia, vasopressor use, and patient comfort. The study aims to provide clearer guidance on dosing to improve anesthesia safety in pregnant women undergoing cesarean delivery.

CONDITIONS

Brief Title

Height Adjusted Versus Standardized Dose of Bupivacaine for Spinal Anesthesia

Who Can Participate

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Scheduled cesarean section with intrathecal anesthesia
  • Term pregnancy greater than 35 weeks
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Unscheduled or emergent cesarean section
  • Any contraindication to intrathecal anesthesia
  • Use of antihypertensive drugs during pregnancy
  • Pre-eclampsia or eclampsia
  • History of Marfan or Ehlers Danlos disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 4 hours since the start of intrathecal bupivacaine administration

Participants receive spinal anesthesia with either a standardized dose or a height-adjusted dose of bupivacaine along with morphine and sufentanil during cesarean delivery.

1 visit (in-person, during cesarean section)

Trial Site Locations

Total: 1 location

1

Caen University Hospital

Caen, France

Actively Recruiting

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Research Team

J

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

T

thérèse simonet, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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