Height Adjusted Versus Standardized Dose of Bupivacaine for Spinal Anesthesia

Cesarean Section Complications Clinical Trial

— RAMCES  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05233462
• Other study ID #: 21-0217
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2021
• Source: University Hospital, Caen
• Contact: jean-luc hanouz, M.D, Ph.D
• Phone: 02 31 06 47 36
• Email: hanouz-jl[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• standardized dose
intrathecal anesthesia with 10 mg of bupivacaine
• adjusted dose
intrathecal anesthesia with 0.05 mg of bupivacaine par cm of patient's height

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of arterial hypotension	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	4 hours since the start of intrathecal bupivacaine administration
Secondary	vasopressor total dose	total dose of vasopressor administered during intrathecal anesthesia	4 hours since the start of intrathecal bupivacaine administration
Secondary	metameric level of intrathecal anesthesia	clinical evaluation of the metameric level obtained during intrathecal anesthesia	4 hours since the start of intrathecal bupivacaine administration
Secondary	lower limb motor block at the end of the caesarean section	lower limb motor block at the end of the caesarean section using Bromage score	5 min after the end of caesarean section at newborn umbilical cord clamp
Secondary	rate of need for general anesthesia	rate of need for general anesthesia because of intrathecal anesthesia failure or overdose	5 min after the end of caesarean section at newborn umbilical cord clamp
Secondary	patient's comfort self evaluation	patient's comfort self evaluation using a verbal rating scale from 0 (uncomfortable) to 10 (totally comfortable)	4 hours since the start of intrathecal bupivacaine administration