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NCT Number: NCT05233462

Height Adjusted Versus Standardized Dose of Bupivacaine for Spinal Anesthesia

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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Key information

Conditions

Regional Anesthesia Morbidity Cesarean Section Complications Local Anesthetic Complication

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Caen University Hospital

Caen, France

Location status: Recruiting

Location contact

Jean Luc Hanouz

CONTACT

[email protected]

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standardized dose

Other

intrathecal anesthesia with 10 mg of bupivacaine

Other names: standardized dose of bupivacaine

adjusted dose

Other

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

Other names: adjusted dose of bupivacaine

Primary outcomes

  1. rate of arterial hypotension

    Time frame: 4 hours since the start of intrathecal bupivacaine administration

    rate of arterial hypotension defined as a 20% or more decrease in systolic arterial pressure as compared with baseline systolic arterial pressure measured at 32 weeks

Secondary outcomes

  1. vasopressor total dose

    Time frame: 4 hours since the start of intrathecal bupivacaine administration

    total dose of vasopressor administered during intrathecal anesthesia

  2. metameric level of intrathecal anesthesia

    Time frame: 4 hours since the start of intrathecal bupivacaine administration

    clinical evaluation of the metameric level obtained during intrathecal anesthesia

  3. 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

    lower limb motor block at the end of the caesarean section using Bromage score

  4. rate of need for general anesthesia

    Time frame: 5 min after the end of caesarean section at newborn umbilical cord clamp

    rate of need for general anesthesia because of intrathecal anesthesia failure or overdose

  5. patient's comfort self evaluation

    Time frame: 4 hours since the start of intrathecal bupivacaine administration

    patient's comfort self evaluation using a verbal rating scale from 0 (uncomfortable) to 10 (totally comfortable)

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

02 31 06 47 36 ext. +33 1

thérèse simonet, M.D.

CONTACT

[email protected]

02 31 06 47 36 ext. +33 1

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Acronym: RAMCES

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Feb 10, 2022
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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