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Height Adjusted Versus Standardized Dose of Bupivacaine for Spinal Anesthesia

NCT05233462 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-07-25

No results posted yet for this study

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.

Conditions

  • Regional Anesthesia Morbidity
  • Cesarean Section Complications
  • Local Anesthetic Complication

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

Sponsors & Collaborators

  • University Hospital, Caen

    lead OTHER

Principal Investigators

  • jean-luc hanouz · University Hospital of Caen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-23
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05233462 on ClinicalTrials.gov