Height Adjusted Versus Standardized Dose of Bupivacaine for Spinal Anesthesia (RAMCES)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cesarean Section Complications; Regional Anesthesia Morbidity; Local Anesthetic Complication
• Intervention / Treatment: Other: standardized dose; Other: adjusted dose

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: jean-luc hanouz, M.D, Ph.D; Phone Number: +33 1 02 31 06 47 36; Email: hanouz-jl@chu-caen.fr
• Study Contact Backup: Name: thérèse simonet, M.D.; Phone Number: +33 1 02 31 06 47 36; Email: simonet-t@chu-caen.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; intrathecal administration of a solution containing; bupivacaine 10 mg; morphine 100 micrograms; sufentanil 3 micrograms	Other: standardized dose; intrathecal anesthesia with 10 mg of bupivacaine; Other Names: standardized dose of bupivacaine
Experimental: individualized group; intrathecal administration of a solution containing; bupivacaine 0.05 mg per cm of patient's height; morphine 100 micrograms; sufentanil 3 micrograms	Other: adjusted dose; intrathecal anesthesia with 0.05 mg of bupivacaine par cm of patient's height; Other Names: adjusted dose of bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
vasopressor total dose	total dose of vasopressor administered during intrathecal anesthesia	4 hours since the start of intrathecal bupivacaine administration
metameric level of intrathecal anesthesia	clinical evaluation of the metameric level obtained during intrathecal anesthesia	4 hours since the start of intrathecal bupivacaine administration
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Study Chair: jean-luc hanouz, University Hospital of Caen

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): February 10, 2022
• Last Update Submitted That Met QC Criteria: January 31, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: cesarean section; bupivacaine; morbidity; intrathecal anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 21-0217

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No